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

Out-of-hospital Cardiac Arrest Clinical Trial

— CAAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02327026
• Other study ID #: P130932
• Secondary ID: 2014-A01109-38
• Status: Completed
• Phase: N/A
• First received: December 23, 2014
• Last updated: May 9, 2017
• Start date: March 9, 2015
• Est. completion date: March 30, 2017

Study information

• Verified date: May 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2043
• Est. completion date: March 30, 2017
• Est. primary completion date: March 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

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.
• 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

Locations

Country	Name	City	State
France	Avicenne Hospital - Aphp	Bobigny	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Survival at hospital admission		Day 0
Secondary	Survival		Day 28
Secondary	Survival at hospital discharge		up to Day 28
Secondary	Neurologic outcomes assessed by modified Rankin scale score		Day 28
Secondary	Rate of return of spontaneous circulation (ROSC)		Day 0
Secondary	Intubation difficulty assessed by Intubation difficulty Scale score		Day 0
Secondary	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	Day 0
Secondary	Complications related to bag-valve-mask ventilation	Complications related to bag-valve-mask ventilation during advanced CPR: regurgitation of gastric content	Day 0
Secondary	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)	Day 0, Day 28
Secondary	Ventilation difficulty with bag-valve-mask measured with a visual-analog-scale (VAS)		Day 0
Secondary	Han's mask ventilation classification		Day 0
Secondary	Difficult mask ventilation signs		Day 0
Secondary	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	Day 0
Secondary	Duration of the interruption of chest compression during TI procedure	Duration of the interruption of chest compression during TI procedure	Day 0
Secondary	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)	Day 0
Secondary	Duration of advanced CPR	Duration of advanced CPR (from medical team's arrival to decision to stop CPR)	Day 0