ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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


Condition or disease Intervention/treatment Phase
Out-of-hospital Cardiac Arrest Procedure: bag-valve-mask ventilation Procedure: tracheal intubation Not Applicable

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  (Clinical Trial)
Actual Enrollment : 2043 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Initial Airway Management in Patients With Out-of-Hospital Cardiac Arrest: Tracheal Intubation vs. Bag-valve-mask Ventilation - CAAM STUDY
Actual Study Start Date : March 9, 2015
Actual Primary Completion Date : March 30, 2017
Actual Study Completion Date : March 30, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Survival at hospital admission [ Time Frame: Day 0 ]
  2. Survival [ Time Frame: Day 28 ]
  3. Survival at hospital discharge [ Time Frame: up to Day 28 ]
  4. Neurologic outcomes assessed by modified Rankin scale score [ Time Frame: Day 28 ]
  5. Rate of return of spontaneous circulation (ROSC) [ Time Frame: Day 0 ]
  6. Intubation difficulty assessed by Intubation difficulty Scale score [ Time Frame: Day 0 ]
  7. 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

  8. 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

  9. 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)

  10. Ventilation difficulty with bag-valve-mask measured with a visual-analog-scale (VAS) [ Time Frame: Day 0 ]
  11. Han's mask ventilation classification [ Time Frame: Day 0 ]
  12. Difficult mask ventilation signs [ Time Frame: Day 0 ]
  13. 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

  14. Duration of the interruption of chest compression during TI procedure [ Time Frame: Day 0 ]
    Duration of the interruption of chest compression during TI procedure

  15. 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)

  16. Duration of advanced CPR [ Time Frame: Day 0 ]
    Duration of advanced CPR (from medical team's arrival to decision to stop CPR)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02327026


Locations
France
Avicenne Hospital - Aphp
Bobigny, Ile de France, France, 93000
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Frédéric ADNET, MD, PhD Assistance Publique - Hôpitaux de Paris

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02327026     History of Changes
Other Study ID Numbers: P130932
2014-A01109-38 ( Other Identifier: IDRCB )
First Posted: December 30, 2014    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: May 2017

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Out-of-hospital cardiac arrest
Bag-valve-mask ventilation
Tracheal intubation

Additional relevant MeSH terms:
Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases