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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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


Detailed Summary:

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.


Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Survival with favorable neurological function defined as Glasgow-Pittsburgh Cerebral Performance Categories (CPC) of 2 or less. [ Time Frame: Day 28 ]

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


Original Primary Outcome: Survival with favorable neurological function defined as Glasgow-Pittsburgh Cerebral Performance Categories (CPC) of 2 or less [ Time Frame: Day 28 ]

Survival at 28-day with favorable neurological function defined as Glasgow-Pittsburgh Cerebral Performance Categories (CPC) of 2 or less


Current Secondary Outcome:

  • Survival at hospital admission [ Time Frame: Day 0 ]
  • Survival [ Time Frame: Day 28 ]
  • Survival at hospital discharge [ Time Frame: up to Day 28 ]
  • Neurologic outcomes assessed by modified Rankin scale score [ Time Frame: Day 28 ]
  • Rate of return of spontaneous circulation (ROSC) [ Time Frame: Day 0 ]
  • Intubation difficulty assessed by Intubation difficulty Scale score [ Time Frame: Day 0 ]
  • Complications related to tracheal intubation [ Time Frame: Day 0 ]
    Complications related to tracheal intubation during advanced Cardiopulmonary Resuscitation (CPR): failure, esophageal intubation, mainstem intubation, vomiting, pulmonary aspiration, dental trauma, extubation
  • Complications related to bag-valve-mask ventilation [ Time Frame: Day 0 ]
    Complications related to bag-valve-mask ventilation during advanced CPR: regurgitation of gastric content
  • Technique's failure defined as mortality [ Time Frame: Day 0, Day 28 ]
    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)
  • Ventilation difficulty with bag-valve-mask measured with a visual-analog-scale (VAS) [ Time Frame: Day 0 ]
  • Han's mask ventilation classification [ Time Frame: Day 0 ]
  • Difficult mask ventilation signs [ Time Frame: Day 0 ]
  • Time to completion of tracheal intubation (TI) procedure [ Time Frame: Day 0 ]
    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
  • Duration of the interruption of chest compression during TI procedure [ Time Frame: Day 0 ]
    Duration of the interruption of chest compression during TI procedure
  • Duration of the interruption of chest compression during advanced CPR (from medical team's arrival to decision to stop CPR) [ Time Frame: Day 0 ]
    Duration of the interruption of chest compression during advanced CPR (from medical team's arrival to decision to stop CPR)
  • Duration of advanced CPR [ Time Frame: Day 0 ]
    Duration of advanced CPR (from medical team's arrival to decision to stop CPR)


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: December 23, 2014
Date Started: March 9, 2015
Date Completion:
Last Updated: May 9, 2017
Last Verified: May 2017