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Completed

NCT Number: NCT02327026

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

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

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Key information

Conditions

Out-Of-Hospital Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Avicenne Hospital - Aphp

Bobigny, Île-de-France Region, 93000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bag-valve-mask ventilation

Procedure

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

Procedure

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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: CAAM

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 30, 2014
Registry last updated
May 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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