BVM vs ETI for Arrest
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Clinical Question
In adult patients with an out of hospital cardiac arrest (OHCA), is the use of simple Bag-Valve-Mask (BVM) non-inferior to Endotracheal Intubation (ETI) for advanced airway management in terms of favourable functional outcomes at 28 days.
Bottom Line
In short, Ryan Radecki put it best: "BMV is not inferior, but not non-inferior, to ETI. This is why everyone hates Journal Club."[1]
Major Points
Obtaining and maintaining a patent airway during cardiac arrest rescue therapy is paramount. Intubation during in-hospital arrest is commonplace but little is known of the long-term outcomes associated with this intervention. Previous trials have suggested that intubation during resuscitation may be harmful in both the pediatric [2] and adult populations [3]
In this trial conducted in Belgium and France, pre-hospital management of advanced airway using BVM was compared to ETI for fabourable functional outcome at 28 days. BVM did not meet the non-inferiority margin with a favourable outcome in 4.5% for BVM compared to 4.2% in ETI, but was also not inferior. Return of Spontaneous Circulation (ROSC) had a ARR with ETI of 4.7% (P = 0.03) but no difference in survival to hospital or at 28 days. Airway management difficulty, gastric regurgitation, and airway failure was more common with the BVM but 10% of ETI had esophageal intubation. Together this equalized the patient outcomes in this trial.
The generalizability of this trial may be of concern, given that physicians are part of the ACLS EMS team which may not be found in all jurisdictions. This was only reviewed in the out of hospital setting so this may not be applicable to inpatients.
The larger question, given the large number of patients to survive and the small numbers of patients to have a favourable functional survival, how best to identify those patients that will benefit from intervention.
Guidelines
As of April 2018, no guidelines have been published that reflect the results of this trial.
Design
- Multi-centre, randomized, parallel-group, non-inferiority, parallel-group trial
- N=2043
- Bag-Valve Mask (n=1020)
- Endotracheal Intubation (n=1023)
- Setting: 20 Pre-hospital emergency medical services (France n=15 and Belgium n=5)
- Enrollment: 9 March 201 to 2 January 2017
- Mean follow-up: 26 January 2017
- Analysis: Intention-to-treat, non-inferior margin -1%
- Primary Outcome: Favorable neurological outcome at 28 days
Population
Inclusion Criteria
- ≥ 18 years old
- out-of-hospital cardiac arrest
Exclusion Criteria
- suspected massive aspiration before resuscitation
- presence of a do-not-resuscitate order
- known pregnancy
- imprisonment
Baseline Characteristics
BMV group displayed
- Demographics: mean Age, 65.7 years, Female 32.6%,
- Comorbidities: Hypertension 33%, Coronary Artery Disease 19%, Diabetes 18%, Tobacco use 17%, COPD 12%, Heart Failure 10.5%, Ethanol Abuse 9%, Neurologic disorder 8%, Cancer 7%, Psychiatric disorder 5%, Dementia 3%, Liver disease 2.5%, Hemodialysis 2.5%, HIV 1%
- Activity limitation: Good health 53%, Moderate limitation 27%, Chronic disease 12%, Severe restriction 8%
- Anthropomorphics: median estimated BMI 26.0
- Arrest Etiology: cardiac 68%, non-cardiac 27%, Traumatic 5%
- Arrest: occurred at home 76%, witnessed 71%, by-stander CPR 48%, by-stander ventilation 6%, median no-flow time 5min, median time from collapse to initiation of ACLS 20min, use of mechanical compression device 21%, ECMO-CPR 3%
- Cardiac Rhythm: shockable first rhythm 17%, Asystole 72%, PEA 12%, Ventricular fibrillation 16%, Ventricular tachycardia 0.5%
- Drugs administered pre-hospital: Epinepherine 95%, Amiodarone 20%, Lidocaine 1%, Fibrinolytic 1.5%
Interventions
Interventions done with standard supports, 30:2 CPR, and BVM as part of BLS until ACLS team and physician available
- Bag-Valve-Mask (BVM)
- Endotracheal Intubation (ETI)
Outcomes
Comparisons are Bag-Valve-Mask (BVM) vs. Endotracheal Intubation (ETI).
Primary Outcomes
- Favourable functional survival at day 28
- 4.5% vs. 4.2% (difference 0.11% [1-sided 97.5% CI, −1.64% to infinity]; P for non-inferiority = 0.11)
Secondary Outcomes
- Rate of ROSC (Return of Spontaneous Circulation)
- 34.2% vs. 38.9% (difference −4.7% [95% CI, −8.8% to −0.5%]; P = 0.03)
- Survival to hospital admission
- 28.9% vs. 32.6% (difference, −3.7% [95% CI, −7.7% to 0.3%]; P = 0.07)
- Survival to day 28
- 5.4% vs. 5.3% (difference, 0.1% [95% CI, −1.8% to 2.1%]); P = 0.9)
Adverse Events
- Airway management difficulty
- 18.1% vs. 13.4% (difference 4.7% [95% CI, 1.5% to 7.9%]; P = 0.004)
- Failure
- 6.7% vs. 2.1% (difference, 4.6% [95% CI, 2.8% to 6.4%]; P < 0.001)
- Regurgitation of gastric contents
- 15.2% vs. 7.5% (difference, 7.7% [95% CI, 4.9% to 10.4%]; P < .001)
- Recognized esophageal intubation
- N/A vs. 10%
Post-Hoc Analysis
BVM n=56 vs. ETI n=59
- Chest compression fraction
- 86% vs. 87% (difference, −1% [95% CI −4% to 2%]; P = .70)
- Pauses >2-seconds
- 27 vs. 16 (difference, 11 seconds [95% CI, 7 to 15]; P < .001)
Criticisms
- Favourable Neurological Outcome (Glasgow-Pittsburgh Cerebral Performance Categories 2 or less [4]) was dichotomized for this trial
- Generalizability limited - Physician available in ACLS EMS ambulance which is not available in all jurisdictions
- Trial did not include in-patient management
- Secondary analysis failed to demonstrate non-inferiority or inferiority and can only be hypothesis generating
Funding
- French Ministry of Health - Programme Hospitalier de Recherche Clinique 2013
- Assistance Publique Hôpitaux de Paris (AP-HP)
Further Reading
- ↑ A Non-Non-Answer in Airway Management in OHCA, Emergency Medicine Literature of Note[1]
- ↑ Andersen LW et al. Association Between Tracheal Intubation During Pediatric In-Hospital Cardiac Arrest and Survival. JAMA 2016. 316:1786-1797.
- ↑ Andersen LW et al. Association Between Tracheal Intubation During Adult In-Hospital Cardiac Arrest and Survival. JAMA 2017. 317:494-506.
- ↑ Jacobs I et al. Cardiac arrest and cardiopulmonary resuscitation outcome reports: update and simplification of the Utstein templates for resuscitation registries: a statement for healthcare professionals from a task force of the International Liaison Committee on Resuscitation (American Heart Association, European Resuscitation Council, Australian Resuscitation Council, New Zealand Resuscitation Council, Heart and Stroke Foundation of Canada, InterAmerican Heart Foundation, Resuscitation Councils of Southern Africa). Circulation 2004. 110:3385-97.