Tracheal Intubation vs. Bag-valve-mask Ventilation in Patients With Out-of-Hospital Cardiac Arrest _ CAAM STUDY (CAAM)

Initial Airway Management in Patients With Out-of-Hospital Cardiac Arrest: Tracheal Intubation vs. Bag-valve-mask Ventilation - CAAM STUDY

The aim of this study is to improve the management of patients in cardiac arrest, and this by comparing two initial airway management methods: Tracheal intubation and bag-valve-mask ventilation.

The survival rate at 28-day with favorable neurological function will be compared in the tracheal intubation group versus the bag-valve-mask group

Study Overview

• Status: Completed
• Conditions: Out-of-hospital Cardiac Arrest
• Intervention / Treatment: Procedure: bag-valve-mask ventilation; Procedure: tracheal intubation

Detailed Description

It is a multicenter prospective non-inferiority open randomized controlled trial in patients with out-of-hospital cardiac arrest carried out in physician-staffed emergency medical services.

The investigators hypothesis is that basic airway management (i.e. bag-valve-mask ventilation) is safe and may avoid the deleterious effects of tracheal intubation including interruption of chest compressions.

On medical team's arrival at the scene and after verification of participant's eligibility, patients will be enrolled in the study and randomly assigned to either initial bag-valve-mask ventilation or tracheal intubation. After the hospital admission, all patients will be intubated whatever the initial airway management.

• Study Type: Interventional
• Enrollment (Actual): 2043
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Ile de France
    • Bobigny, Ile de France, France, 93000
      • Avicenne Hospital - Aphp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 years or older;
• Patient with out-of-hospital cardiac arrest on medical team's arrival
• Resuscitation attempted
• Medical insurance

Exclusion Criteria:

• Massive suspected aspiration
• Presence of do-not-resuscitate order
• Pregnancy
• Prisoners

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: bag-valve-mask ventilation; Airway management including initial bag-valve-mask ventilation by the medical team during OHCA. When standard bag-valve-mask ventilation is possible, the patient will be intubated in case of a return of spontaneous circulation. When standard bag-valve-mask ventilation is impossible or in case of massive regurgitation of gastric content (after randomisation), intubation of patient is the preferred alternative	Procedure: bag-valve-mask ventilation; Airway management including initial bag-valve-mask ventilation by the medical team during OHCA. When standard bag-valve-mask ventilation is possible, the patient will be intubated in case of a return of spontaneous circulation. When standard bag-valve-mask ventilation is impossible or in case of massive regurgitation of gastric content (after randomisation), intubation of patient is the preferred alternative.
Active Comparator: tracheal intubation; Tracheal intubation during OHCA by the medical team: The standard intubation procedure is to use a non-styletted tube and no sedation. When standard laryngoscopy-assisted intubation is not possible, an alternate procedure will be used based on the French consensus conference guidelines on difficult airway management.	Procedure: tracheal intubation; Tracheal intubation during OHCA by the medical team: The standard intubation procedure is to use a non-styletted tube and no sedation. When standard laryngoscopy-assisted intubation is not possible, an alternate procedure will be used based on the French consensus conference guidelines on difficult airway management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival with favorable neurological function defined as Glasgow-Pittsburgh Cerebral Performance Categories (CPC) of 2 or less.	Survival at 28-day with favorable neurological function defined as Glasgow-Pittsburgh Cerebral Performance Categories (CPC) of 2 or less. In case of neurological disability before randomization, the survival associated the same degree of disability will be considered a favorable neurological function	Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival at hospital admission		Day 0
Survival		Day 28
Survival at hospital discharge		up to Day 28
Neurologic outcomes assessed by modified Rankin scale score		Day 28
Rate of return of spontaneous circulation (ROSC)		Day 0
Intubation difficulty assessed by Intubation difficulty Scale score		Day 0
Complications related to tracheal intubation	Complications related to tracheal intubation during advanced Cardiopulmonary Resuscitation (CPR): failure, esophageal intubation, mainstem intubation, vomiting, pulmonary aspiration, dental trauma, extubation	Day 0
Complications related to bag-valve-mask ventilation	Complications related to bag-valve-mask ventilation during advanced CPR: regurgitation of gastric content	Day 0
Technique's failure defined as mortality	Technique's failure defined as mortality at 28-day or regurgitation during the procedure or failure of the procedure (failure to ventilate in the bag-valve-mask ventilation or failure to intubate in the intubation group)	Day 0, Day 28
Ventilation difficulty with bag-valve-mask measured with a visual-analog-scale (VAS)		Day 0
Han's mask ventilation classification		Day 0
Difficult mask ventilation signs		Day 0
Time to completion of tracheal intubation (TI) procedure	Time to completion of tracheal intubation (TI) procedure measured from the instant that the laryngoscope blade touches the patient to the moment that the tracheal tube cuff is inflated	Day 0
Duration of the interruption of chest compression during TI procedure	Duration of the interruption of chest compression during TI procedure	Day 0
Duration of the interruption of chest compression during advanced CPR (from medical team's arrival to decision to stop CPR)	Duration of the interruption of chest compression during advanced CPR (from medical team's arrival to decision to stop CPR)	Day 0
Duration of advanced CPR	Duration of advanced CPR (from medical team's arrival to decision to stop CPR)	Day 0

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Frédéric Adnet, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• Jabre P, Penaloza A, Pinero D, Duchateau FX, Borron SW, Javaudin F, Richard O, de Longueville D, Bouilleau G, Devaud ML, Heidet M, Lejeune C, Fauroux S, Greingor JL, Manara A, Hubert JC, Guihard B, Vermylen O, Lievens P, Auffret Y, Maisondieu C, Huet S, Claessens B, Lapostolle F, Javaud N, Reuter PG, Baker E, Vicaut E, Adnet F. Effect of Bag-Mask Ventilation vs Endotracheal Intubation During Cardiopulmonary Resuscitation on Neurological Outcome After Out-of-Hospital Cardiorespiratory Arrest: A Randomized Clinical Trial. JAMA. 2018 Feb 27;319(8):779-787. doi: 10.1001/jama.2018.0156.

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2015
• Primary Completion (Actual): March 30, 2017
• Study Completion (Actual): March 30, 2017

Study Registration Dates

• First Submitted: December 23, 2014
• First Submitted That Met QC Criteria: December 29, 2014
• First Posted (Estimate): December 30, 2014

Study Record Updates

• Last Update Posted (Actual): May 10, 2017
• Last Update Submitted That Met QC Criteria: May 9, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Tracheal intubation; Out-of-hospital cardiac arrest; Bag-valve-mask ventilation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: P130932; 2014-A01109-38 (Other Identifier: IDRCB)