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Anesthesiology (all articles)

RCT: Interruption of Oral Anticoagulation during TAVI Reduces Bleeding Without Increasing Thromboembolic Events

7 Sep, 2024 | 12:43h | UTC

Study Design and Population: This international, open-label, randomized noninferiority trial examined 858 patients undergoing transcatheter aortic-valve implantation (TAVI) who had an indication for oral anticoagulation due to concomitant diseases. Patients were randomized 1:1 to either continue or interrupt their oral anticoagulation during the procedure, with the primary outcome being a composite of cardiovascular death, stroke, myocardial infarction, major vascular complications, or major bleeding within 30 days.

Main Findings: Primary outcome events occurred in 16.5% of the continuation group and 14.8% of the interruption group, showing a non-significant risk difference of 1.7 percentage points (95% CI, -3.1 to 6.6). Thromboembolic events were similar between groups (8.8% in continuation vs. 8.2% in interruption). However, bleeding events were significantly higher in the continuation group (31.1% vs. 21.3%; risk difference, 9.8 percentage points; 95% CI, 3.9 to 15.6).

Implications for Practice: Interrupting oral anticoagulation during TAVI significantly reduces bleeding without increasing thromboembolic risks, suggesting it may be a safer strategy for patients undergoing TAVI. These findings could influence clinical decision-making regarding anticoagulation management in this population.

Reference: van Ginkel, D.J. et al. (2024). Continuation versus Interruption of Oral Anticoagulation during TAVI. The New England Journal of Medicine. https://doi.org/10.1056/NEJMoa2407794

 


RCT: Continuing Aspirin vs. Antiplatelet Cessation Before Surgery Did Not Reduce Ischemic Events in Patients With Coronary Stents Over 1 Year Post-Implantation

7 Sep, 2024 | 12:29h | UTC

Study Design and Population: This randomized controlled trial (ASSURE-DES) investigated the perioperative management of antiplatelet therapy in 926 patients with coronary drug-eluting stents (DES) undergoing low-to-intermediate-risk noncardiac surgery. The patients, at least one year post-stent implantation, were randomized to continue aspirin monotherapy or stop all antiplatelet therapy five days prior to surgery.

Main Findings: The study found no significant difference in the primary composite outcome (death, myocardial infarction, stent thrombosis, or stroke) between the aspirin monotherapy group (0.6%) and the no antiplatelet group (0.9%). However, minor bleeding was more frequent in the aspirin group (14.9% vs 10.1%, P=0.027), with no difference in major bleeding.

Implications for Practice: These results suggest that for stable patients with DES undergoing noncardiac surgery, temporarily discontinuing aspirin may be a safe option, as continuing aspirin did not reduce ischemic events but did increase minor bleeding risk. Further research is needed to assess outcomes in higher-risk surgical settings.

Reference: Kang, D.-Y. et al. (2024). Aspirin monotherapy vs no antiplatelet therapy in stable patients with coronary stents undergoing low-to-intermediate risk noncardiac surgery. Journal of the American College of Cardiology. https://doi.org/10.1016/j.jacc.2024.08.024

 


News Release: SCOFF Trial Confirms Fasting Not Necessary Before Cardiac Catheterisation Procedures

7 Sep, 2024 | 10:10h | UTC

1 September 2024 – London, United Kingdom – New findings from the SCOFF trial, presented at ESC Congress 2024, suggest that fasting prior to minimally invasive cardiac catheterisation procedures under conscious sedation does not increase the risk of complications. The trial supports reconsidering current guidelines on pre-procedural fasting.

Key Points for Physicians:

– No increased complications: The SCOFF trial found no significant difference in adverse outcomes, such as aspiration pneumonia or hypoglycemia, between patients who fasted and those who ate normally before cardiac catheterisation.

– Improved patient satisfaction: Patients who did not fast reported higher satisfaction, with fewer complaints of discomfort and hunger.

– Potential guideline change: These findings, in line with previous studies like CHOW-NOW and TONIC, challenge the necessity of fasting before such procedures.

The trial’s lead investigator, Dr. David Ferreira (John Hunter Hospital, Australia), emphasized that avoiding fasting may improve patient experience without increasing risks, making it time to reconsider fasting guidelines for these procedures.

Study Overview:

– Trial design: Prospective, randomized, open-label, with blinded endpoint assessment.

– Participants: 716 patients undergoing coronary angiography, coronary intervention, or cardiac implantable electronic device procedures.

– Primary endpoint: Composite of hypotension, aspiration pneumonia, hyperglycemia, and hypoglycemia, showing a lower event rate in the non-fasting group (12.0%) compared to the fasting group (19.1%).

These results are likely to influence future clinical practice, providing greater flexibility for both patients and healthcare systems.

Source: https://www.escardio.org/The-ESC/Press-Office/Press-releases/SCOFF-trial-confirms-that-fasting-is-not-needed-before-cath-lab-procedures

 


RCT: No Difference in Postoperative Complications Between Continuation and Discontinuation of Renin-Angiotensin System Inhibitors Before Major Surgery – JAMA

31 Aug, 2024 | 19:12h | UTC

Study Design and Population: This multicenter randomized clinical trial included 2,222 patients who had been treated with renin-angiotensin system inhibitors (RASIs) for at least 3 months and were scheduled for major noncardiac surgery at 40 hospitals in France between January 2018 and April 2023. The participants were randomly assigned to either continue RASIs until the day of surgery or to discontinue them 48 hours before surgery.

Main Findings: The trial found no significant difference in the primary outcome—a composite of all-cause mortality and major postoperative complications within 28 days—between the continuation and discontinuation groups (22% in both groups, RR 1.02, 95% CI 0.87-1.19). However, the continuation group experienced a higher incidence of intraoperative hypotension (54% vs. 41%, RR 1.31, 95% CI 1.19-1.44).

Implications for Practice: Continuation of RASIs before major noncardiac surgery does not increase the risk of postoperative mortality or major complications, but it does elevate the risk of intraoperative hypotension. Clinicians should weigh these risks when deciding whether to continue or discontinue RASIs before surgery.

Reference: Legrand M, Falcone J, Cholley B, et al. (2024). Continuation vs Discontinuation of Renin-Angiotensin System Inhibitors Before Major Noncardiac Surgery: The Stop-or-Not Randomized Clinical Trial. JAMA. https://doi.org/10.1001/jama.2024.17123

 


Meta-Analysis: ERAS Protocols Improve Recovery and Reduce Complications After Emergency Laparotomy – Am J Surg

18 Aug, 2024 | 19:32h | UTC

Study Design and Population: This systematic review and meta-analysis assessed the effects of Enhanced Recovery After Surgery (ERAS) protocols compared to standard care (SC) in patients undergoing emergency laparotomy. The analysis included six randomized clinical trials (RCTs) with a total of 509 patients.

Main Findings: The ERAS group showed a reduction in length of hospital stay (mean difference: -2.92 days) and quicker recovery milestones, such as time to ambulation (mean difference: -1.67 days) and first bowel opening (mean difference: -1.26 days). The ERAS protocols were also associated with lower rates of pulmonary complications (odds ratio [OR]: 0.43) and surgical site infections (OR: 0.33). Mortality rates were similar between the ERAS and SC groups.

Implications for Practice: These findings suggest that ERAS protocols may enhance recovery and reduce complications in patients undergoing emergency laparotomy. Implementation of these protocols could be beneficial in emergency surgical settings, where feasible.

Reference: Amir AH, Davey MG, Donlon NE. (2024). Evaluating the Impact of Enhanced Recovery After Surgery Protocols following Emergency Laparotomy – A Systematic Review and Meta-Analysis of Randomised Clinical Trials. The American Journal of Surgery. DOI: https://doi.org/10.1016/j.amjsurg.2024.115857.

 


Updated Guidelines on Perioperative Management of Anticoagulant and Antiplatelet Therapy for Interventional Techniques – Pain Physician

18 Aug, 2024 | 14:52h | UTC

Introduction: The American Society of Interventional Pain Physicians (ASIPP) has published updated guidelines for the perioperative management of patients undergoing interventional techniques while receiving antiplatelet and anticoagulant therapy. These guidelines are essential for clinicians to balance the risk of thromboembolism against the risk of bleeding during interventional procedures.

Key Points:

1 – Risk of Thromboembolic Events:

– Thromboembolic events have a higher risk of morbidity and mortality compared to the risk of epidural hematoma. Thus, interruption of antithrombotic therapy should be carefully considered.

2 – Risk Stratification of Procedures:

– Interventional techniques are classified into three categories based on risk: low, moderate, or high. For high-risk procedures, cessation of anticoagulant or antiplatelet therapy is recommended, whereas for low to moderate-risk procedures, therapy may continue under certain conditions.

3 – Management of Direct Oral Anticoagulants (DOACs):

– DOACs such as dabigatran, apixaban, rivaroxaban, and edoxaban should generally be discontinued for 2 days before high-risk procedures and one day for moderate-risk procedures. Adjustments are needed based on renal function, specially for dabigatran.

4 – Discontinuation of Aspirin:

– For high-risk interventional procedures, discontinuation of aspirin (81 or 325 mg) is recommended 6 days before the procedure. However, for low to moderate-risk procedures, aspirin therapy may be continued or stopped for 3 days depending on individual risk factors and clinical judgment.

5 – Discontinuation of Other Antiplatelet Agents:

– Clopidogrel (Plavix) and Prasugrel (Effient): These agents should be discontinued 6 days before high-risk procedures. For low-risk procedures, these medications can be continued.

– Ticagrelor (Brilinta): Discontinue for 5 days before high-risk procedures, with consideration of patient-specific risk factors.

6 – Timing for Restarting Therapy:

– Antithrombotic therapy should typically be resumed within 12-24 hours after low to moderate-risk procedures and within 24-48 hours after high-risk procedures, depending on bleeding risk and patient status.

7 – Shared Decision-Making:

– Decisions on whether to continue or discontinue antithrombotic therapy should involve shared decision-making between the patient, the interventional pain specialist, and other treating physicians, considering all associated risks.

Conclusion: These guidelines provide a comprehensive framework for managing the delicate balance between thromboembolic and bleeding risks in patients on anticoagulant or antiplatelet therapy undergoing interventional procedures. They emphasize the importance of personalized care and multidisciplinary collaboration.

Guideline Reference: Manchikanti, L., et al. (2024). Perioperative Management of Antiplatelet and Anticoagulant Therapy in Patients Undergoing Interventional Techniques: 2024 Updated Guidelines From The American Society Of Interventional Pain Physicians (ASIPP). Pain Physician, 27(S1-S94).

 


Review: Prevention and Management of Device-Associated Complications in the Intensive Care Unit – The BMJ

17 Aug, 2024 | 20:04h | UTC

Introduction:

This review article, published by experts from the David Geffen School of Medicine at UCLA, focuses on the complications associated with invasive devices commonly used in the Intensive Care Unit (ICU). While these devices are essential for managing critically ill patients, they also pose significant risks, necessitating a thorough understanding of their potential complications and strategies for prevention and management.

Key Points:

1 – Central Venous Catheters (CVCs):

– CVCs are widely used in ICU patients but carry risks like vascular injury, pneumothorax, thrombosis, and infection.

– Use of real-time ultrasound guidance and careful operator technique are crucial for minimizing these risks.

– Prompt removal of unnecessary CVCs is essential to reduce the risk of complications.

2 – Arterial Catheters:

– Commonly used for hemodynamic monitoring, these catheters can lead to complications such as vascular occlusion, nerve injury, and infection.

– Ultrasound guidance is recommended to reduce the risk of complications, and catheters should be discontinued as soon as clinically feasible.

3 – Airway Devices (Endotracheal Tubes and Tracheostomies):

– Complications include laryngeal injury, tracheal stenosis, and tracheomalacia.

– Strategies to reduce these risks include minimizing intubation attempts, ensuring proper tube placement, and managing cuff pressures carefully.

4 – Extracorporeal Membrane Oxygenation (ECMO):

– ECMO is associated with significant complications, including bleeding, thromboembolic events, and neurologic injuries.

– Proper cannulation technique and vigilant monitoring are essential to mitigate these risks.

5 – Infection Control:

– Strict adherence to aseptic techniques and the use of chlorhexidine-impregnated dressings are recommended to prevent device-associated infections.

Conclusion:

This review underscores the importance of judicious use and timely removal of invasive devices in the ICU to minimize complications. Healthcare professionals must remain vigilant and employ best practices to prevent and manage these complications effectively.

Reference: Hixson, R., Jensen, K. S., Melamed, K. H., & Qadir, N. (2024). Device associated complications in the intensive care unit. BMJ, 386, e077318. http://dx.doi.org/10.1136/bmj-2023-077318

 


RCT: Hypothermic Oxygenated Perfusion Trends Toward Lower Primary Graft Dysfunction in Heart Transplantation – The Lancet

17 Aug, 2024 | 19:38h | UTC

Study Design and Population: This randomized, controlled, open-label, multicenter clinical trial evaluated the safety and efficacy of hypothermic oxygenated machine perfusion (HOPE) compared to static cold storage (SCS) in preserving donor hearts for transplantation. Conducted across 15 transplant centers in eight European countries, the study enrolled 229 adult heart transplant candidates between November 2020 and May 2023. The trial included 204 patients who received a transplant and met the study’s inclusion and exclusion criteria.

Main Findings: The primary composite endpoint, including cardiac-related death, graft dysfunction, and rejection within 30 days post-transplant, occurred in 19% of patients in the HOPE group compared to 30% in the SCS group, reflecting a 44% risk reduction (HR 0.56, 95% CI 0.32–0.99, p=0.059). Notably, primary graft dysfunction was significantly lower in the HOPE group (11% vs. 28%, RR 0.39, 95% CI 0.20–0.73). The incidence of major adverse cardiac transplant events was also reduced with HOPE (18% vs. 32%, RR 0.56, 95% CI 0.34–0.92).

Implications for Practice: HOPE showed a potential clinical benefit by reducing the incidence of primary graft dysfunction and major adverse cardiac events after heart transplantation. Although the primary endpoint was not statistically significant, the observed risk reductions suggest that HOPE could improve outcomes in heart transplantation. Further research is needed to confirm these findings and optimize donor heart preservation strategies.

Reference: Rega, F., Lebreton, G., Para, M., Michel, S., Schramm, R., Begot, E., et al. (2024). Hypothermic oxygenated perfusion of the donor heart in heart transplantation: the short-term outcome from a randomised, controlled, open-label, multicentre clinical trial. The Lancet, 404(10453), 670-682. DOI: https://doi.org/10.1016/S0140-6736(24)01078-X.

 


RCT: Routine Protamine Administration Enhances Hemostasis and Reduces Vascular Complications in TAVI – JAMA Cardiol

17 Aug, 2024 | 19:09h | UTC

Study Design and Population: The ACE-PROTAVI trial was a double-blind, placebo-controlled randomized clinical trial conducted at three Australian hospitals. It involved 410 patients (median age 81 years) undergoing transfemoral transcatheter aortic valve implantation (TAVI). The trial evaluated the efficacy and safety of routine protamine administration versus placebo.

Main Findings: Patients receiving protamine showed a higher rate of successful hemostasis (97.9% vs. 91.6%) and a significantly shorter time to hemostasis (median 181 vs. 279 seconds). Protamine administration also led to a reduced risk of composite vascular complications (5.2% vs. 12.8%), primarily due to fewer minor vascular events. No adverse events were associated with protamine.

Implications for Practice: Routine protamine administration after TAVI improves hemostasis, reduces minor vascular complications, and shortens procedural and postprocedural recovery times, suggesting it should be considered in standard TAVI protocols.

Reference: Vriesendorp, P. A., Nanayakkara, S., Heuts, S., et al. (2024). Routine Protamine Administration for Bleeding in Transcatheter Aortic Valve Implantation: The ACE-PROTAVI Randomized Clinical Trial. JAMA Cardiology. Published online August 14, 2024. DOI: 10.1001/jamacardio.2024.2454.

 


New AHA Guidelines for Managing Elevated Blood Pressure in Acute Care Settings – Hypertension

13 Aug, 2024 | 13:13h | UTC

Introduction:

The American Heart Association (AHA) has released a scientific statement focusing on the management of elevated blood pressure (BP) in acute care settings. This guideline addresses the significant variation in practice due to a lack of robust evidence for managing BP in such environments, particularly in emergencies or when elevated BP is asymptomatic.

Key Points:

1 – Classification of Elevated BP: Elevated BP in acute care settings is categorized into asymptomatic elevated BP and hypertensive emergency, the latter requiring immediate treatment due to acute target-organ damage.

2 – Hypertensive Emergency: Immediate treatment is necessary for patients with BP >180/110–120 mm Hg and evidence of new or worsening target-organ damage, typically using intravenous antihypertensive medications in a closely monitored environment.

3 – Asymptomatic Elevated BP: In cases where elevated BP is present without symptoms or target-organ damage, the use of antihypertensive medications should be approached cautiously. Recent studies suggest potential harm from aggressive treatment, highlighting the importance of verifying BP readings and identifying reversible causes before intervention.

4 – Proper BP Measurement: Accurate BP measurement is crucial. The guidelines stress using recently calibrated devices and following correct measurement techniques to avoid unnecessary treatment due to erroneous readings.

5 – PRN Orders: The use of “as needed” (PRN) antihypertensive medications for asymptomatic elevated BP is discouraged due to the risks of overtreatment and variability in BP control, which can lead to adverse outcomes.

6 – Treatment Thresholds: The guidelines recommend a high threshold for initiating or intensifying antihypertensive treatment in asymptomatic patients, emphasizing the need for repeated measurements and assessment of underlying causes.

7 – Post-Discharge Care: It is crucial to maintain prehospital antihypertensive regimens and avoid intensification at discharge unless clearly indicated. Effective care coordination and patient education are vital for successful transitions from hospital to home care.

Conclusion:

These guidelines represent a significant step toward standardizing BP management in acute care settings. By focusing on accurate measurement, cautious treatment of asymptomatic elevated BP, and proper follow-up, clinicians can reduce unnecessary interventions and improve patient outcomes.

Guideline Reference: Bress, A.P., et al. (2024). “The Management of Elevated Blood Pressure in the Acute Care Setting: A Scientific Statement from the American Heart Association.” Hypertension, 81–e106.

 


RCT: Eliminating Fasting Before Contrast-Enhanced CT in Outpatients Reduces Nausea and Vomiting Without Increasing Acute Adverse Reactions – Insights Imaging

11 Aug, 2024 | 13:41h | UTC

Study Design and Population: This single-center, randomized clinical trial was conducted in Spain with 1,103 adult outpatients undergoing non-emergency contrast-enhanced CT scans. Patients were randomized into two groups: one group fasted for at least 6 hours (control), while the other group had no food restrictions (intervention). The primary aim was to assess whether eliminating fasting affects the incidence of acute adverse reactions (AARs), such as nausea and vomiting.

Main Findings: The study found no significant difference in the overall incidence of acute adverse reactions between the fasting and non-fasting groups (3.21% vs. 2.30%; p = 0.36). However, the non-fasting group had a significantly lower incidence of nausea and vomiting (0.92% vs. 2.86%; p = 0.02). Multivariate logistic regression identified fasting, age, allergies, neurological diseases, and contrast media concentration as independent risk factors for nausea and vomiting.

Implications for Practice: The findings suggest that the traditional practice of fasting before contrast-enhanced CT scans is unnecessary and may increase the risk of nausea and vomiting. Therefore, unrestricted food intake should be allowed for most contrast-enhanced CT exams, reserving fasting only for specific imaging procedures.

Reference: Zitan Saidi et al. (2024). Fasting before contrast-enhanced CT and the incidence of acute adverse reactions: a single-center randomized clinical trial. Insights into Imaging, 15(195). DOI: 10.1186/s13244-024-01767-9.

 


Meta-Analysis: Daily Sedation Interruption Shortens PICU Stay Without Impacting Mortality or Ventilation Duration in Pediatric MV Patients – JAMA Netw Open

11 Aug, 2024 | 13:19h | UTC

Study Design and Population: This systematic review and meta-analysis included six randomized clinical trials (RCTs) involving 2,810 pediatric patients receiving mechanical ventilation (MV) in the pediatric intensive care unit (PICU). The trials compared the effects of daily sedation interruption (DSI) with continuous intravenous (IV) sedation on clinical outcomes such as MV duration and PICU length of stay.

Main Findings: The analysis found that DSI was associated with a significant reduction in the length of PICU stay (mean difference of -1.45 days, p = 0.03). However, there was no significant difference in the duration of MV between DSI and continuous sedation (mean difference of -0.93 days, p = 0.06). Additionally, there were no significant differences in total sedative doses, adverse events, or mortality between the two groups.

Implications for Practice: The findings suggest that DSI may reduce the length of PICU stay without increasing the risk of adverse events, making it a potentially valuable strategy in managing sedation for pediatric patients on MV. However, further research is needed to explore the long-term neurodevelopmental outcomes associated with DSI.

Reference: Shu Wen Toh, T. et al. (2024). Daily Sedation Interruption vs Continuous Sedation in Pediatric Patients Receiving Mechanical Ventilation: A Systematic Review and Meta-analysis. JAMA Network Open, 7(8), e2426225. DOI: 10.1001/jamanetworkopen.2024.26225.

 


RCT: Intravenous Amino Acids Reduce AKI Incidence in Cardiac Surgery Patients – N Engl J Med

3 Aug, 2024 | 19:12h | UTC

Study Design and Population: In this multinational, double-blind, randomized clinical trial, 3511 adult patients scheduled for cardiac surgery with cardiopulmonary bypass were recruited from 22 centers across three countries. Patients were randomly assigned to receive an intravenous infusion of either a balanced mixture of amino acids (2 g/kg/day) or a placebo (Ringer’s solution) for up to three days.

Main Findings: The primary outcome, occurrence of acute kidney injury (AKI), was significantly lower in the amino acid group (26.9%) compared to the placebo group (31.7%) with a relative risk of 0.85 (95% CI, 0.77 to 0.94; P=0.002). The incidence of severe AKI (stage 3) was also reduced in the amino acid group (1.6% vs. 3.0%; relative risk, 0.56; 95% CI, 0.35 to 0.87). There were no substantial differences between the groups regarding secondary outcomes such as the use and duration of kidney-replacement therapy or all-cause 30-day mortality.

Implications for Practice: The infusion of amino acids in adult patients undergoing cardiac surgery appears to reduce the incidence of AKI, indicating a potential protective renal effect. However, this intervention did not significantly impact other secondary outcomes, including mortality and the use of kidney-replacement therapy. These findings suggest that amino acids could be considered as a strategy to mitigate AKI risk in this patient population, although further research is needed to explore long-term benefits and other clinical outcomes.

Reference: Landoni G, Monaco F, Ti LK, Baiardo Redaelli M, Bradic N, Comis M, Kotani Y, for the PROTECTION Study Group. (2024). A randomized trial of intravenous amino acids for kidney protection. New England Journal of Medicine, 390(24), 1765-1774. DOI: 10.1056/NEJMoa2403769.


RCT: Liberal vs. Restrictive Transfusion Strategy Shows No Significant Difference in Neurologic Outcomes for Traumatic Brain Injury Patients – N Engl J Med

3 Aug, 2024 | 19:06h | UTC

Study Design and Population: This randomized clinical trial evaluated the effects of liberal versus restrictive red cell transfusion strategies in 742 adults with moderate to severe traumatic brain injury (TBI) and anemia. Participants were randomized to either a liberal transfusion strategy (initiated at hemoglobin ≤10 g/dL) or a restrictive strategy (initiated at hemoglobin ≤7 g/dL). The primary outcome was an unfavorable neurologic outcome at 6 months, assessed using the Glasgow Outcome Scale–Extended.

Main Findings: The study found that 68.4% of patients in the liberal-strategy group and 73.5% in the restrictive-strategy group experienced an unfavorable outcome (adjusted absolute difference of 5.4 percentage points; 95% CI, −2.9 to 13.7). No significant difference in mortality or depression was observed between the two groups. Although some functional independence and quality of life measures were better in the liberal group among survivors, venous thromboembolic events and acute respiratory distress syndrome rates were comparable.

Implications for Practice: The findings indicate that a liberal transfusion strategy does not significantly improve neurologic outcomes at 6 months in critically ill TBI patients compared to a restrictive strategy. Clinicians may consider maintaining a restrictive transfusion strategy, given the similar outcomes and potential for fewer transfusions. Further research is needed to explore specific subgroups that might benefit from different transfusion strategies.

Reference: Turgeon AF, Fergusson DA, Clayton L, et al. (2024). Liberal or Restrictive Transfusion Strategy in Patients with Traumatic Brain Injury. New England Journal of Medicine, 390(24), 1234-1245. DOI: 10.1056/NEJMoa2404360.


Guidelines on the use of intravenous albumin in various clinical settings – CHEST

25 May, 2024 | 18:49h | UTC

The International Collaboration for Transfusion Medicine Guidelines provides comprehensive guidelines on the use of intravenous albumin across various clinical settings, including critical care, cardiovascular surgery, kidney replacement therapy, and complications of cirrhosis. The guideline emphasizes that there are few evidence-based indications supporting the routine use of albumin to improve patient outcomes. Key findings include:

 

1 – Critical Care: Limited recommendations for using albumin in adult, pediatric, and neonatal critical care, primarily advising against its routine use for volume replacement or managing hypoalbuminemia due to low or very low certainty of evidence.

2 – Cardiovascular Surgery: No recommendations for using albumin to prime cardiovascular bypass circuits or for volume replacement due to moderate to very low certainty of evidence.

3 – Kidney Replacement Therapy: Albumin is not suggested for preventing or managing intradialytic hypotension or improving ultrafiltration due to very low certainty of evidence.

4 – Cirrhosis Complications: Some conditional recommendations for using albumin in specific scenarios like large-volume paracentesis and spontaneous bacterial peritonitis due to low certainty of evidence; however, it is generally not suggested for other complications of cirrhosis.

 

Overall, the guidelines advise a cautious approach to albumin use, highlighting the need for more robust evidence to support its broader application in clinical practice.

 

Reference (link to free full-text):

Callum J et al. (2024). Use of Intravenous Albumin: A Guideline From the International Collaboration for Transfusion Medicine Guidelines. CHEST, 2024. DOI: https://doi.org/10.1016/j.chest.2024.02.049.

 


RCT: Triple combination of paracetamol, ibuprofen, and dexamethasone reduces morphine use post-hip arthroplasty – Lancet Rheumatol

11 May, 2024 | 14:18h | UTC

Study Design and Population: The RECIPE trial was a randomized, blinded, placebo-controlled multicenter study conducted across nine Danish hospitals to evaluate the effectiveness of non-opioid analgesic combinations in managing postoperative pain following total hip arthroplasty. A total of 1,060 adults scheduled for surgery were enrolled and randomly assigned to one of four treatment groups, receiving combinations of paracetamol, ibuprofen, and dexamethasone. The study’s primary endpoint was the 24-hour intravenous morphine consumption, with a predefined minimal important difference set at 8 mg.

Main Findings: The trial results indicated significant reductions in 24-hour morphine consumption in the group receiving paracetamol, ibuprofen, and dexamethasone combined, compared to other groups, though none reached the minimal important difference. Specifically, this group consumed a median of 15 mg morphine, which was less than the other groups ranging from 16 mg to 24 mg. However, the differences did not meet the study’s threshold for a clinically important effect. Adverse events were lowest in the combined treatment group, suggesting a better safety profile primarily characterized by fewer incidents of nausea, vomiting, and dizziness.

Implications for Practice: The findings support the use of a combined regimen of paracetamol, ibuprofen, and dexamethasone for reducing morphine consumption post-total hip arthroplasty, which could be significant in clinical settings aiming to minimize opioid use. The improved safety profile also highlights the potential benefits of multimodal analgesia. Further research may explore the optimization of dosing schedules and long-term outcomes to enhance patient recovery and satisfaction.

 

Reference (link to abstract – $ for full-text):

Steiness J et al. (2024). Non-opioid analgesic combinations following total hip arthroplasty (RECIPE): a randomised, placebo-controlled, blinded, multicentre trial. The Lancet Rheumatology, 6(4), e205-e215. DOI: 10.1016/S2665-9913(24)00020-1

 


Cluster Randomized Trial: Hyperangulated video laryngoscopy reduces intubation attempts in surgical patients – JAMA

11 May, 2024 | 13:39h | UTC

Study Design and Population: This cluster randomized multiple crossover clinical trial was conducted at a single U.S. academic hospital to compare the effectiveness of hyperangulated video laryngoscopy versus direct laryngoscopy in reducing the number of intubation attempts during surgery. The study involved 7,736 adult patients, aged 18 years or older, undergoing elective or emergent cardiac, thoracic, or vascular surgical procedures that required single-lumen endotracheal intubation for general anesthesia. The trial randomized two sets of 11 operating rooms on a weekly basis to use either video laryngoscopy or direct laryngoscopy for the initial intubation attempt from March 2021 to December 2022.

Main Findings: Hyperangulated video laryngoscopy significantly decreased the number of intubation attempts compared to direct laryngoscopy. Specifically, 1.7% of surgical procedures using video laryngoscopy required more than one intubation attempt versus 7.6% for direct laryngoscopy, with an estimated proportional odds ratio of 0.20 (95% CI, 0.14-0.28; P < .001). Furthermore, intubation failure was markedly lower with video laryngoscopy (0.27%) compared to direct laryngoscopy (4.0%). However, there was no significant difference in the rates of airway and dental injuries between the two methods.

Implications for Practice: The findings indicate that hyperangulated video laryngoscopy enhances initial intubation success and reduces the need for multiple intubation attempts in a variety of surgical settings. This suggests that video laryngoscopy could be considered a preferable technique for endotracheal intubation in the operating room, potentially improving patient outcomes and efficiency. Further research might explore the generalizability of these results to other medical centers and different patient populations.

 

Reference (link to abstract – $ for full-text):

Ruetzler, K. et al. (2024). Cluster Randomized Trial: Hyperangulated Video Laryngoscopy Reduces Intubation Attempts in Surgical Patients. JAMA, 331(15), 1279-1286. DOI: 10.1001/jama.2024.0762

 


RCT: Video laryngoscopy improves first-attempt intubation success in neonates compared to direct laryngoscopy – N Engl J Med

11 May, 2024 | 13:37h | UTC

Study Design and Population: This single-center randomized clinical trial investigated the efficacy of video laryngoscopy versus direct laryngoscopy for urgent intubation in neonates. A total of 226 neonates requiring intubation either in the delivery room or neonatal intensive care unit (NICU) were enrolled and stratified by gestational age into two groups: less than 32 weeks and 32 weeks or more. The study primarily focused on the success rate of the first intubation attempt, monitored through exhaled carbon dioxide detection.

Main Findings: The trial included 214 neonates, analyzing the success of intubation on the first attempt. Video laryngoscopy significantly outperformed direct laryngoscopy, achieving a first-attempt success rate of 74% (95% confidence interval [CI], 66 to 82) compared to 45% (95% CI, 35 to 54) in the direct laryngoscopy group. Moreover, the median number of attempts for successful intubation was lower in the video-laryngoscopy group (1 attempt, 95% CI, 1 to 1) versus the direct-laryngoscopy group (2 attempts, 95% CI, 1 to 2). Additionally, neonates in the video laryngoscopy group experienced higher median lowest oxygen saturations and heart rates during intubation.

Implications for Practice: The findings suggest that video laryngoscopy could be more effective than direct laryngoscopy for urgent neonatal intubation, particularly in increasing the likelihood of success on the first attempt. These results recommend reconsidering current intubation techniques in neonatal care settings to incorporate video laryngoscopy, potentially leading to safer and more efficient intubation processes in this vulnerable population.

 

Reference (link to abstract – $ for full-text):

Geraghty, L.E. et al. (2024). Video versus Direct Laryngoscopy for Urgent Intubation of Newborn Infants. The New England Journal of Medicine. DOI: 10.1056/NEJMoa2402785.

 


RCT: Serratus anterior plane block reduces pain and opioid use in rib fracture patients – JAMA Surgery

2 May, 2024 | 23:20h | UTC

Study Design and Population:
This study was a multicenter, open-label, pragmatic randomized clinical trial conducted across eight emergency departments in New South Wales, Australia. The trial included 210 patients aged 16 years or older who had clinically suspected or radiologically confirmed rib fractures. Patients intubated, transferred for urgent surgical intervention, or with major concomitant nonthoracic injuries were excluded.

 

Main Findings:
In the trial, patients were randomized to receive either a serratus anterior plane block (SAPB) along with standard rib fracture management or standard care alone. The primary outcome was a composite pain score measured 4 hours post-enrollment. The SAPB group showed a significant increase in patients achieving the desired pain score reduction (41% in SAPB group vs. 19.6% in control; RR 0.73, 95% CI 0.60-0.89, P = 0.001). Additionally, SAPB recipients had significantly lower opioid consumption at 24 hours compared to the control group.

 

Implications for Practice:

The trial’s results support the addition of a serratus anterior plane block (SAPB) to standard rib fracture management for providing effective early pain relief and reducing opioid use. However, it’s important to note that this study did not include a sham group, and patients were aware of whether they received the intervention. This lack of blinding could influence patient-reported outcomes due to placebo effects. Despite this limitation, the reduction in pain and opioid consumption suggests that SAPB is a beneficial component of care for patients with rib fractures.

 

Reference (link to abstract – $ for full-text):

Reference: Partyka, C. et al. (2024). Serratus Anterior Plane Blocks for Early Rib Fracture Pain Management The SABRE Randomized Clinical Trial. JAMA Surg. Published online May 1, 2024. DOI: 10.1001/jamasurg.2024.0969

 


RCT: Free Access to Water vs. Fasting Pre-Cesarean Reduces Vomiting and Increases Maternal Satisfaction

25 Mar, 2024 | 11:17h | UTC

Study Design and Population: This randomized controlled trial was carried out at the Obstetric Unit, Universiti Malaya Medical Center from October 2020 to May 2022. A total of 504 women scheduled for planned cesarean delivery under spinal anesthesia were randomized into two groups: 252 were allowed free access to water up until being called to the operating theater, and 252 were required to fast from midnight before the procedure. The study primarily aimed to evaluate the effects of these preoperative oral intake policies on perioperative vomiting and maternal satisfaction.

Main Findings: The results demonstrated significant benefits for the group with free access to water. Specifically, perioperative vomiting was observed in 3.6% of women with water access compared to 9.5% of those fasting, indicating a relative risk reduction. Maternal satisfaction scores were notably higher in the water access group, with median scores of 9 versus 5 for the fasting group. Additional findings included lower reports of thirst, fewer instances of preoperative intravenous hydration, reduced ketone presence in urine, and a lower average number of vasopressor doses needed. Significantly, 95.2% of participants in the water access group would recommend their regimen to a friend, compared to only 39.7% in the fasting group.

Implications for Practice: Allowing free access to water up until the time of surgery for women scheduled for cesarean delivery under spinal anesthesia significantly reduces the risk of perioperative vomiting and improves maternal satisfaction, without adversely affecting post-cesarean recovery or neonatal outcomes. These findings support revising current preoperative fasting guidelines to improve patient experience and potentially enhance clinical outcomes.

Reference: Ng, Y. L., Segaran, S., Yim, C. C. W., Lim, B. K., Hamdan, M., Gan, F., & Tan, P. C. (2024). Preoperative free access to water compared to fasting for planned cesarean under spinal anesthesia: A randomized controlled trial. American Journal of Obstetrics and Gynecology, S0002-9378(24)00447-2. DOI: 10.1016/j.ajog.2024.03.018.


Nested Case-Control Study: Increased risk of major bleeding in atrial fibrillation patients with concomitant SSRI and oral anticoagulant use

23 Mar, 2024 | 20:48h | UTC

Study Design and Population

This nested case-control study investigated the association between the concomitant use of selective serotonin reuptake inhibitors (SSRIs) and oral anticoagulants (OACs) on the risk of major bleeding among patients with atrial fibrillation. Conducted within the UK’s Clinical Practice Research Datalink, the study included 42,190 cases of major bleeding matched to 1,156,641 controls based on age, sex, cohort entry date, and follow-up duration. Patients initiating OACs between January 2, 1998, and March 29, 2021, were included, with risk-set sampling utilized for control selection.

Main Findings

The study found that concomitant use of SSRIs and OACs was associated with a 33% increased risk of major bleeding compared to OAC use alone, with the highest risk observed within the first 30 days of concurrent use. The increased risk was consistent across different ages, sexes, and patient histories, including those with chronic kidney disease or previous bleeding events. Notably, the elevated risk of bleeding extended up to 6 months of concomitant use but did not vary significantly with the potency of SSRIs or the type of OAC used (direct OACs or vitamin K antagonists).

Implications for Practice

These findings underscore the need for healthcare professionals to closely monitor patients with atrial fibrillation who are prescribed SSRIs in addition to OACs, particularly during the initial months of treatment. This study highlights the importance of managing bleeding risk factors and suggests reconsidering the necessity and duration of concomitant SSRI and OAC use. Future research should focus on strategies to mitigate this bleeding risk and explore alternative treatments for managing depression in patients requiring anticoagulation.

Reference

Rahman AA, Platt RW, Beradid S, et al. (2024). Concomitant Use of Selective Serotonin Reuptake Inhibitors With Oral Anticoagulants and Risk of Major Bleeding. JAMA Netw Open, 7(3):e243208. DOI: 10.1001/jamanetworkopen.2024.3208.


RCT: Lower oxygenation target improves days alive without life support in severe COVID-19 hypoxemia

21 Mar, 2024 | 13:46h | UTC

Study Design and Population: This multicenter randomized clinical trial investigated the impact of different oxygenation targets on the survival of adult patients with COVID-19 and severe hypoxemia in the ICU. Conducted across 11 European ICUs from August 2020 to March 2023, the study involved 726 patients requiring at least 10 L/min of oxygen or mechanical ventilation. Participants were randomly assigned to receive an oxygenation target of either 60 mm Hg (lower oxygenation group, n=365) or 90 mm Hg (higher oxygenation group, n=361) for up to 90 days.

Main Findings: The primary outcome was the number of days alive without life support at 90 days post-intervention. Patients in the lower oxygenation group achieved a median of 80.0 days alive without life support compared to 72.0 days in the higher oxygenation group, a difference that was statistically significant (P=0.009). Although there was a slight reduction in mortality at 90 days in the lower oxygenation group (30.2% vs 34.7% in the higher group), this was not statistically significant. No significant differences were observed in the proportion of patients with serious adverse events or the number of days alive and out of hospital.

Implications for Practice: Targeting a lower Pao2 of 60 mm Hg in ICU patients with COVID-19 and severe hypoxemia appears to increase the days alive without life support compared to a higher target of 90 mm Hg, without increasing serious adverse events. This finding suggests that a lower oxygenation target could be more beneficial for this patient population, potentially guiding clinical practice in managing oxygen therapy for severe COVID-19 cases.

Reference

Reference: Nielsen FM et al. (2024). Randomized Clinical Trial: Effect of Oxygenation Targets on Survival Without Life Support in COVID-19 Patients with Severe Hypoxemia. JAMA, Published online March 19, 2024. DOI: 10.1001/jama.2024.2934. Access the study here: [Link]


RCT: Propafenone leads to quicker sinus rhythm restoration than amiodarone in supraventricular arrhythmias related to septic shock

1 Oct, 2023 | 15:19h | UTC

Study Design & Population: The research was a two-center, prospective, controlled parallel-group, double-blind trial involving 209 septic shock patients who had new-onset supraventricular arrhythmia and a left ventricular ejection fraction above 35%. Patients were randomized to receive either intravenous propafenone (70 mg bolus followed by 400–840 mg/24 h) or amiodarone (300 mg bolus followed by 600–1800 mg/24 h).

Main Findings: The primary outcomes focused on the proportion of patients in sinus rhythm 24 hours post-infusion, time to the first sinus rhythm restoration, and arrhythmia recurrence rates. No significant difference was observed in 24-hour sinus rhythm rates between the propafenone (72.8%) and amiodarone (67.3%) groups (p=0.4). Time to the first rhythm restoration was significantly shorter for the propafenone group (median 3.7 hours) compared to the amiodarone group (median 7.3 hours, p=0.02). Recurrence of arrhythmia was notably lower in the propafenone group (52%) than in the amiodarone group (76%, p<0.001). In the subgroup of patients with a dilated left atrium, amiodarone appeared to be more effective.

Implications & Limitations: The study suggests that while propafenone doesn’t offer better rhythm control at 24 hours compared to amiodarone, it does provide faster cardioversion and fewer arrhythmia recurrences, especially in patients with a non-dilated left atrium. No significant differences were observed in clinical outcomes, such as ICU or long-term mortality, between propafenone and amiodarone in the trial. Limitations include potential underpowering of the study and the inability to fully account for the impact of multiple covariates involved in the complex therapy of septic shock.

Article: Balik, M., Maly, M., Brozek, T. et al. Propafenone versus amiodarone for supraventricular arrhythmias in septic shock: a randomised controlled trial. Intensive Care Med (2023)

 

Commentary on Twitter:

 


RCT | Restrictive vs. liberal red blood cell transfusion strategy for critically injured patients

11 Aug, 2023 | 15:08h | UTC

The Restrictive Red Blood Cell Transfusion Strategy for Critically Injured Patients (RESTRIC) trial: a cluster-randomized, crossover, non-inferiority multicenter trial of restrictive transfusion in trauma – Journal of Intensive Care

 


Review | Regional anesthesia in the emergency department outside the operating theatre

8 Aug, 2023 | 13:17h | UTC

Regional anesthesia in the emergency department outside the operating theatre – Current Opinion in Anaesthesiology

 


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