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

NCT02327026 | Completed DMC

• 2 other identifiers: P1309322014-A01109-38
• Study Type: interventional
• Target: 2,043
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Out-of-hospital Cardiac Arrest

Keywords

Out-of-hospital cardiac arrest; Bag-valve-mask ventilation; Tracheal intubation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• 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

Study Arms (2)

bag-valve-mask ventilation

EXPERIMENTAL

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

tracheal intubation

ACTIVE COMPARATOR

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

Interventions

bag-valve-mask ventilation PROCEDURE

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.

bag-valve-mask ventilation

tracheal intubation PROCEDURE

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

tracheal intubation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Avicenne Hospital - Aphp

Bobigny, Île-de-France Region, 93000, France

Location

Related Publications (1)

• 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.

  PMID: 29486039 DERIVED

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Interventions

Intubation, Intratracheal

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Intubation; Investigative Techniques

Study Officials

• Frédéric ADNET, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2014
• First Posted: December 30, 2014
• Study Start: March 9, 2015
• Primary Completion: March 30, 2017
• Study Completion: March 30, 2017
• Last Updated: May 10, 2017

Record last verified: 2017-05

Locations

FR (1)