Verdicts from our biggest study reviews of 2024
Dec 20, 2024We look at:
- The DEVICE Trial
- The CAPE COD Trial
- Management of Cardiogenic Shock in Elderly Patients
- Magnesium in Atrial Fibrillation: 4 Trials
- Pad Placement and Energy levels in Cardioverting AF: 2 Trials
- UK REBOA Trial
- The ARREST Trial
- The PARAMEDIC-3 Trial
- The NEW PECARN C-Spine Rules
1. The DEVICE Trial
Prekker M.E. et al Video versus Direct Laryngoscopy for Tracheal Intubation of Critically iLL Adults. NEJM June 16 2023
This was a pragmatic, multicentre, randomised, unblinded, parallel-group trial in which Video laryngoscopy was compared to Direct Laryngoscopy for intubation of critically ill patients. It was conducted in 7 Emergency Departments and 10 ICUs. There was 1:1 randomisation to DL or VL. There was no specification of brand or blade size or use of stylette or bougie. Those decisions were all left to the operator.
Primary Outcome
Successful intubation on first attempt.
Verdict
VL results in greater first attempt success than DL and this is more pronounced in those operators with less intubation experience. VL 85.1% / DL 70.8%. (95% CI 9.9-18.7 p<0.001)
2. The CAPE COD Trial
Dequin PF et al. Hydrocortisone in Severe Community Acquired Pneumonia. NEJM 388;21 May 25 2023 pp1931-1941. https://pubmed.ncbi.nlm.nih.gov/36942789/
This was a double-blind, randomised, controlled, superiority trial. conducted in 31 French ICUs.
N=800
Intravenous hydrocortisone, 200mg, was given within 24 hours of onset of severity criteria (median time < 15 hours). It was continued for 4 days and then changed according to pre-defined criteria.
Primary Outcome
Death from any cause at 28 days
Verdict
At 28 days death rate was lower in the hydrocortisone group (6.9% vs 11.9%)
This is an interesting study and one that shows a significant positive effect of steroids in severe community acquired pneumonia. Prior trials, although showing positive effects of steroids, found that they had no effect on mortality.
Given they was no increase in mortality, it’s reasonable to say that glucocorticoids should be considered at < 24 hours in patients meeting the criteria for severe community acquired pneumonia in the CAPE COD Trial, but not in septic shock or with influenza.
3. Management of Cardiogenic Shock in Elderly Patients
Cardiogenic Shock in Older Adults: A Focus on Age-Associated Risks and Approach to Management: A Scientific Statement from the American Heart Association. Circulation. 2024;149:e1051–e1065
This is an AHA Review:
Verdict
Currently there is a lack of good evidence for the very elderly, especially those patients > 80 years of age. Using age only for decision making ignores the presence of other co-morbidities.
There is a higher rate of Acute Myocardial Infarction(AMI)-related cardiogenic shock in patients > 75 years of age in both ST elevation(STE) and non-STE myocardial infarctions(MI)
Solely using hypotension criteria may not be adequate to predict outcomes and measures of rising lactate and creatinine, or measures of combined hypotension and hypoperfusion may be better predictors of mortality.
26 recommendations are made in this study.
4. Magnesium in Atrial Fibrillation
We looked at 4 studies here:
STUDY 1: The LOMAGHI Study which compared low and high dose IV magnesium to placebo and found a difference in the control of rate, but no difference in rhythm control
Bouida W et al. Low-dose magnesium sulfate versus high dose in the early Management of Rapid Atrial Fibrillation: Randomised Controlled Double-blind Study. Acad Emerg Med 2019;26:183-191
This was a prospective, randomised, double-blind study in 3 emergency departments.
Patients were randomised to receive one of three treatments:
- Low Dose Magnesium (4.5 g IV in 100mL normal saline)
- High dose Magnesium (9 g IV in 100 mL normal saline)
- Placebo (100mL normal saline)
Primary Outcome: Ventricular Rate Control at 4 hours ( ie < 90 bpm or reduced by 20%)
There was a significant difference between both Magnesium Groups and the Placebo group in terms of therapeutic decrease in ventricular rate.
Conversion to sinus rhythm was not statistically significant between groups at 4 hours.
STUDY 2: An RCT looking at low dose magnesium alone which found no difference to placebo for rate or rhythm control at 2 hours.
Chu K, ey al. Magnesium sulfate versus placebo for paroxysmal atrial fibrillation: a randomized clinical trial. Acad Emerg Med 2009;16:295–300.
This was a double-blinded, placebo-controlled randomised trial, conducted in one emergency department. Patients were adults with atrial fibrillation of less than 48 hours duration.
Primary Objective: Compare heart rate at 2 hours post treatment.
This was a small study, but found no difference in rate or rhythm control with Magnesium
STUDY 3: A systematic review that found that magnesium was effective in both rate and rhythm control
Onalan O et al. Meta-Analysis of Magnesium Therapy for the Acute Management of Rapid Atrial Fibrillation. Am J Card. 2007;99:1726-1732.
This was a systematic review and meta-analysis of 8 randomised controlled trials on the effectiveness of magnesium therapy for the acute management of rapid atrial fibrillation.
Primary Outcomes: Success in achieving rate and/or rhythm control.
Magnesium was more effective than control treatments for: Rate (OR 1.96, 95% CI, 1.24 to 3.08) and Rhythm control (OR 1.60, 95% CI 1.07 to 2.39).
This study also included patients with chronic atrial fibrillation. It may overestimate the effects of magnesium.
STUDY 4: A systematic review that found that magnesium reduces rate, but is not effective at cardioverting AF patients to sinus rhythm
Ho K M. Use of intravenous magnesium to treat acute onset atrial fibrillation: a meta-analysis. Heart 2007;93:1433-1440.
This was a meta analysis of 10 trials, with a mixture of settings including emergency departments, ICU and wards.
They found that IV magnesium is more effective than placebo in reducing the fast ventricular response rate when added to digoxin. In patients with normal serum magnesium levels magnesium but not effective in converting AF to sinus rhythm.
Verdict
Magnesium, may assist in rate control, but is not effective for rhythm control.
5. Pad Placement and Energy Levels for Cardioverting AF
The EPIC Trial
Schmidt A S. Antero-Lateral Versus Anterior-Posterior Electrode Position for Converting Atrial Fibrillation. Circulation. 2021;144:1995–2003.
This was a multicentre, investigator initiated, randomised open-label, blinded-outcome assessment trial. That looked at defibrilator pad placement positions for cardioverting atrial fibrillation.
Primary Outcome: Proportion of patients in sinus rhythm 1 minute after shock.
They patients in sinus rhythm 1 minute after the first shock was
- 54%(126 patients) in the antero-lateral position
- 33%(77) in the antero-posterior position
Verdict
This has changed my practice and I start with anteroom-lateral pad placement
The BEST AF Trial
Glover B M, et al Biphasic Energy Selection for transthoracic cardioversion of atrial fibrillation. The BEST AF Trial. Heart. 2008 Jul;94(7):884-7
This was a Prospective, Multicentre randomised trial, using biphasic defibrillation.
Patients were randomised into 2 groups:
- Escalating Energy: 100J, 150J, 200J, 200J or
- Non-escalating: 200J, 200J, 200J.
First shock success was higher in the non-escalating energy group and certainly in patients with higher BMI. I will certainly use 200J as my first dose.
Verdict
Although this study was not an Emergency Department Study, and the patients had persistent AF, I feel confident in using the results. I would extrapolate that the results in the acute AF patient where electrical and physical remodelling has not yet taken place that using the results may lead to greater success rates.
6. UK-REBOA Trial
Jansen J O et al. Emergency Department Resuscitative Endovascular Balloon Occlusion of the Aorta in Trauma Patients with Exsanguinating Haemorrhage. The UK-REBOA Randomised Clinical Trial. JAMA. 2023;330(19):1862-1871
This was a Multicenter, open label, randomised trial. It was conducted at 16 major trauma centres in the UK. They asked the question: "Does the addition of resuscitative endovascular balloon occlusion of the aorta (REBOA) to standard care reduce mortality in trauma patients with exsanguinating hemorrhage?"
Primary Outcome: All cause mortality at 90 days.
The trial was stopped after second interim analysis, as a pre-specified rule for harm was met (>90% posterior probability or OR > 1 for mortality at 90 days) At this point 90 patients were enrolled, and the study did not achieve the originally planned 120 patients.
Verdict
This was a small sample study of predominant blunt trauma patients, where the procedure was only performed in less than half of the cases that were assigned to it.
What this study reinforces for me is timely control of haemorrhage. Delays in that control result in greater mortality.
7. The ARREST Trial
This was a prospective parallel, multi centre, open-label, randomised superiority trial. It was not blinded. They compared transfer of post OHCA patients to an arrest centre with those delivered to the closest emergency department.
Primary Outcome: all-cause mortality at 30 days
There was no difference in the 2 groups. 30 day all-cause mortality was 63% in the cardiac arrest centre group versus 63% in the standard group ie., there was no difference in patients with cardiac arrest with no ST elevation.
Secondary Outcomes: There was no difference in 3 month mortality outcomes. Neurological outcomes were similar at discharge and at 3 months.
Verdict
This study was conducted in London, a large metropolitan city, with many hospitals and short ambulance transit times.
If the study findings are really true, there is concern that what we do, perhaps provides little benefit. My instinct would say that if the patient goes to a cardiac arrest centre, they would do better, however the standard hospital care, in this study, may be of a significant level, that great care is provided.
It would be interesting to have study that included smaller rural centres. I would hypothesise that the results may be different. More studies are needed.
8. The PARAMEDIC-3 Trial
Couper K et al. A Randomised Trial of Drug Route in Out-of-Hospital Cardiac Arrest. NEJM October 31st 2024 PARAMEDIC-3 Trial
This was an open label, pragmatic, randomised trial, conducted in the United Kingdom.
The PARAMEDIC-3 Trial looked at the clinical effectiveness of an intraosseous first strategy, as compared with an intravenous-first strategy, in adults with out-of- hospital cardiac arrest.
Primary Outcome: Survival at 30 days.
Survival at 30 days was 4.5% (137/3030) (I/O) vs 5.1% (155/3034) in IV group (adjusted odds ratio, 0.94; 95% confidence interval [CI], 0.68 to 1.32; P=0.74) ie., I/O did not increase 30 day survival over IV.
Verdict
This study showed that the use of an I/O-first strategy did not result in higher 30-day survival than an IV-first strategy. The rate of ROSC was lower in those patients with I/O access. However, It would be a one try for IV, then fo to I/O. This is not the patient to be bringing the ultrasound to the bedside for.
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9. The New PECARN C-Spine Rules
Leonard J C et al. PECARN prediction rule for cervical spine imaging of children presenting to the emergency department with blunt trauma: a multicentre prospective observational study. Lancet Child Adolesc Health 2024; 8: 482–90. doi:10.1016/S2352-4642(24)00104-4
This was a prospective observational study, of children 0–17 years with known or suspected blunt trauma presenting to one of 18 PECARN affiliated level-1 paediatric trauma centres. They derived and validated a clinical prediction rule for cervical injury in children.
Primary Outcome: Cervical spine injury within 28 days of trauma requiring inpatient admission or surgical intervention.
They found that there were high risk and lower risk features. They combined these to create a 9 factor prediction rule with a:
- sensitivity of 94·3% (95% CI 90·7–97·9),
- specificity of 60·4% (59·4–61·3), and
- NPV of 99·9% (99·8–100·0).
Verdict
This is a well done study that provides a simple tiered approach to determining who needs imaging and what kind of imaging is needed.
The aim of this study was to reduce the amount of imaging, especially of CTs, as they pose a significant radiation risk and an increased incidence of cancer. There is no doubt that the high risk group, in this study, would most likely receive CT imaging. However, in the lesser risk group, that imaging may now be replaced by plain C-spine series x-rays..... which concerns me a little.
There is no mechanism incorporated into this rule and this was done on purpose. However the mechanism, for me becomes very important as some injuries are of such high risk, that we may be doing a CT early and others of such low risk, that I won't image.
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