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

Primary Purpose

Out-of-hospital Cardiac Arrest

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
bag-valve-mask ventilation
tracheal intubation
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Out-of-hospital Cardiac Arrest focused on measuring Out-of-hospital cardiac arrest, Bag-valve-mask ventilation, Tracheal intubation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Avicenne Hospital - Aphp

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

bag-valve-mask ventilation

tracheal intubation

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Survival at hospital admission
Survival
Survival at hospital discharge
Neurologic outcomes assessed by modified Rankin scale score
Rate of return of spontaneous circulation (ROSC)
Intubation difficulty assessed by Intubation difficulty Scale score
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
Complications related to bag-valve-mask ventilation
Complications related to bag-valve-mask ventilation during advanced CPR: regurgitation of gastric content
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)
Ventilation difficulty with bag-valve-mask measured with a visual-analog-scale (VAS)
Han's mask ventilation classification
Difficult mask ventilation signs
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
Duration of the interruption of chest compression during TI procedure
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)
Duration of the interruption of chest compression during advanced CPR (from medical team's arrival to decision to stop CPR)
Duration of advanced CPR
Duration of advanced CPR (from medical team's arrival to decision to stop CPR)

Full Information

First Posted
December 23, 2014
Last Updated
May 9, 2017
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02327026
Brief Title
Tracheal Intubation vs. Bag-valve-mask Ventilation in Patients With Out-of-Hospital Cardiac Arrest _ CAAM STUDY
Acronym
CAAM
Official Title
Initial Airway Management in Patients With Out-of-Hospital Cardiac Arrest: Tracheal Intubation vs. Bag-valve-mask Ventilation - CAAM STUDY
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 9, 2015 (Actual)
Primary Completion Date
March 30, 2017 (Actual)
Study Completion Date
March 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Out-of-hospital Cardiac Arrest
Keywords
Out-of-hospital cardiac arrest, Bag-valve-mask ventilation, Tracheal intubation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2043 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bag-valve-mask ventilation
Arm Type
Experimental
Arm Description
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
Arm Title
tracheal intubation
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
bag-valve-mask ventilation
Intervention Description
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 Type
Procedure
Intervention Name(s)
tracheal intubation
Intervention Description
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 Measure Information:
Title
Survival with favorable neurological function defined as Glasgow-Pittsburgh Cerebral Performance Categories (CPC) of 2 or less.
Description
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
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Survival at hospital admission
Time Frame
Day 0
Title
Survival
Time Frame
Day 28
Title
Survival at hospital discharge
Time Frame
up to Day 28
Title
Neurologic outcomes assessed by modified Rankin scale score
Time Frame
Day 28
Title
Rate of return of spontaneous circulation (ROSC)
Time Frame
Day 0
Title
Intubation difficulty assessed by Intubation difficulty Scale score
Time Frame
Day 0
Title
Complications related to tracheal intubation
Description
Complications related to tracheal intubation during advanced Cardiopulmonary Resuscitation (CPR): failure, esophageal intubation, mainstem intubation, vomiting, pulmonary aspiration, dental trauma, extubation
Time Frame
Day 0
Title
Complications related to bag-valve-mask ventilation
Description
Complications related to bag-valve-mask ventilation during advanced CPR: regurgitation of gastric content
Time Frame
Day 0
Title
Technique's failure defined as mortality
Description
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)
Time Frame
Day 0, Day 28
Title
Ventilation difficulty with bag-valve-mask measured with a visual-analog-scale (VAS)
Time Frame
Day 0
Title
Han's mask ventilation classification
Time Frame
Day 0
Title
Difficult mask ventilation signs
Time Frame
Day 0
Title
Time to completion of tracheal intubation (TI) procedure
Description
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
Time Frame
Day 0
Title
Duration of the interruption of chest compression during TI procedure
Description
Duration of the interruption of chest compression during TI procedure
Time Frame
Day 0
Title
Duration of the interruption of chest compression during advanced CPR (from medical team's arrival to decision to stop CPR)
Description
Duration of the interruption of chest compression during advanced CPR (from medical team's arrival to decision to stop CPR)
Time Frame
Day 0
Title
Duration of advanced CPR
Description
Duration of advanced CPR (from medical team's arrival to decision to stop CPR)
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric ADNET, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Avicenne Hospital - Aphp
City
Bobigny
State/Province
Ile de France
ZIP/Postal Code
93000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
29486039
Citation
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.
Results Reference
derived

Learn more about this trial

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

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