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

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ClinicalTrials.gov Identifier: NCT02327026
Recruitment Status : Completed
First Posted : December 30, 2014
Last Update Posted : May 10, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE December 23, 2014
First Posted Date  ICMJE December 30, 2014
Last Update Posted Date May 10, 2017
Actual Study Start Date  ICMJE March 9, 2015
Actual Primary Completion Date March 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2017)
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 Measures  ICMJE
 (submitted: December 29, 2014)
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
Change History Complete list of historical versions of study NCT02327026 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 29, 2014)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tracheal Intubation vs. Bag-valve-mask Ventilation in Patients With Out-of-Hospital Cardiac Arrest _ CAAM STUDY
Official Title  ICMJE 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 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Out-of-hospital Cardiac Arrest
Intervention  ICMJE
  • 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.
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Procedure: bag-valve-mask ventilation
  • 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.
    Intervention: Procedure: tracheal intubation
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2017)
2043
Original Estimated Enrollment  ICMJE
 (submitted: December 29, 2014)
2000
Actual Study Completion Date  ICMJE March 30, 2017
Actual Primary Completion Date March 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02327026
Other Study ID Numbers  ICMJE P130932
2014-A01109-38 ( Other Identifier: IDRCB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Frédéric ADNET, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP