Out-of-hospital Cardiac ArrestCAAMNCT02327026
Tracheal Intubation vs. Bag-valve-mask Ventilation in Patients With Out-of-Hospital Cardiac Arrest _ CAAM STUDY
A study testing bag-valve-mask ventilation and tracheal intubation in people with Out-of-hospital Cardiac Arrest, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-of-hospital Cardiac Arrest
- What is being tested?
- bag-valve-mask ventilation and tracheal intubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,043 participants
- Where
- 1 siteFrance
- Study dates
- 9 Mar 2015to 30 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older;
- Patient with out-of-hospital cardiac arrest on medical team's arrival
- Resuscitation attempted
- Medical insurance
Who cannot join
- Massive suspected aspiration
- Presence of do-not-resuscitate order
- Pregnancy
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Initial Airway Management in Patients With Out-of-Hospital Cardiac Arrest: Tracheal Intubation vs. Bag-valve-mask Ventilation - 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
Read the 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.
- Conditions
- Out-of-hospital Cardiac Arrest
- Being tested
- bag-valve-mask ventilation, tracheal intubation
- Keywords
- Out-of-hospital cardiac arrest, Bag-valve-mask ventilation, Tracheal intubation
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bag-valve-mask ventilationProcedure or surgery
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 intubationProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| bag-valve-mask ventilation | Experimental | 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 Receives: Procedure: bag-valve-mask ventilation |
| tracheal intubation | Active comparator | 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. Receives: Procedure: tracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 28
Secondary outcomes (16)
Survival at hospital admission
Measured: Day 0
Survival
Measured: Day 28
Survival at hospital discharge
Measured: up to Day 28
Neurologic outcomes assessed by modified Rankin scale score
Measured: Day 28
Rate of return of spontaneous circulation (ROSC)
Measured: Day 0
Intubation difficulty assessed by Intubation difficulty Scale score
Measured: Day 0
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
Measured: Day 0
Complications related to bag-valve-mask ventilation
Complications related to bag-valve-mask ventilation during advanced CPR: regurgitation of gastric content
Measured: Day 0
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)
Measured: Day 0, Day 28
Ventilation difficulty with bag-valve-mask measured with a visual-analog-scale (VAS)
Measured: Day 0
Han's mask ventilation classification
Measured: Day 0
Difficult mask ventilation signs
Measured: Day 0
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
Measured: Day 0
Duration of the interruption of chest compression during TI procedure
Duration of the interruption of chest compression during TI procedure
Measured: Day 0
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)
Measured: Day 0
Duration of advanced CPR
Duration of advanced CPR (from medical team's arrival to decision to stop CPR)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2014 (estimated)
- Study start9 Mar 2015
- Primary completion30 Mar 2017
- Study completion30 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Out-of-hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,043 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric ADNET, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02327026
- Sponsor's protocol ID
- P130932
- Other IDs
- 2014-A01109-38
- Acronym
- CAAM
- Status last verified
- May 2017
- First submitted
- 23 Dec 2014
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 29486039
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Airway Management in Patients With Out-of-Hospital Cardiac Arrest: Tracheal Intubation vs. Bag-valve-mask Ventilation - CAAM STUDY
- ClinicalTrials.gov ID
- NCT02327026
- Acronym / sponsor ID
- CAAM / P130932
- Conditions
- Out-of-hospital Cardiac Arrest
- Keywords
- Out-of-hospital cardiac arrest, Bag-valve-mask ventilation, Tracheal intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,043 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 9 Mar 2015 (actual)
- Primary completion
- 30 Mar 2017 (actual)
- Study completion
- 30 Mar 2017 (actual)
- First posted
- 30 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bag-valve-mask ventilation | Experimental | Procedure: bag-valve-mask ventilationAirway 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 | Active comparator | Procedure: tracheal intubationTracheal 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older;
- Patient with out-of-hospital cardiac arrest on medical team's arrival
- Resuscitation attempted
- Medical insurance
Key exclusion criteria (4 listed)
- Massive suspected aspiration
- Presence of do-not-resuscitate order
- Pregnancy
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bag-valve-mask ventilationAirway 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 or surgery | bag-valve-mask ventilation |
| tracheal intubationTracheal 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 or surgery | tracheal intubation |
Primary outcome
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
16 secondary outcomes
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 bag-valve-mask ventilation
Time frame: Day 0
Technique's failure defined as mortality
Time frame: Day 0, Day 28
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
Duration of the interruption of chest compression during TI procedure
Time frame: Day 0
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 advanced CPR
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Derived from this study: PubMed 29486039Jabre 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédéric ADNET, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bag-valve-mask ventilation and tracheal intubation in people with Out-of-hospital Cardiac Arrest, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival with favorable neurological function defined as Glasgow-Pittsburgh Cerebral Performance Categories (CPC) of 2 or less. (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02327026, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2017.