Cardiac ArrestPhase 4EVENCT01374061
Pre Hospital Evaluation of Video Laryngoscopy
A Phase 4 study testing Classical intubation and GLIDESCOPE in people with Cardiac Arrest and Respiratory Distress Syndrome, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
The objective of this work is to compare standard intubation with video laryngoscope (Glide scope Ranger ) in French pre hospital multicentric study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Respiratory Distress Syndrome, Shock
- What is being tested?
- Classical intubation and GLIDESCOPE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Dec 2012
- Phase
- Phase 4
- 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
- patients of more than 18 years old
- requiring an intubation
- by medical out of hospital emergency operators
- medical insurance
- Consent signed
Who cannot join
- Age <18, pregnant women
- Refusal of consent or inability for understanding study
- small mouth opening makes it impossible intubate
About this study
Official title: Pre Hospital Evaluation of Video Laryngoscopy : a Comparative Study of Macintosh and GLIDESCOPE Ranger®
The objective of this work is to compare standard intubation with video laryngoscope (Glide scope Ranger ) in French pre hospital multicentric study.
Read the detailed description
Introduction: In France, patients in critical status brought to hospital by emergency physicians and nurses experimented in tracheal intubation. It is an invasive act allowing a protection of airways and an optimal oxygenation of the patients in distress. The reference technique is the direct laryngoscopy by Macintosh . Corresponding data shows that a video laryngoscope - GLIDESCOPE laryngoscope - improve the conditions of intubation in the surgical unit thanks to a better display(visualization) of the opening. A derived device for pre hospital emergency units (GLIDESCOPE Ranger®) deserves to be compared with the classic laryngoscopy in emergency conditions.
Objectives: compare the emergency intubation in Pre hospital meadow by Glide Scope Ranger with regard to the classic method
Progress of the study: the patients will be included by emergency physicians working in out of hospital teams of 3 major hospitals of Paris. The patients will be randomized in 2 groups: 1 group classic laryngoscopy (group 1) and a group Glide scope Ranger (group 2). The score IDS will be compared for every group as well as the arisen of a complication during the procedure. The consent will be collected on the place or during the hospitalization.
- Conditions
- Cardiac Arrest, Respiratory Distress Syndrome, Shock, Acute Post-trauma Stress State, Drug Toxicity, Trauma, Nervous System
- Being tested
- Classical intubation, GLIDESCOPE
- Keywords
- Emergency intubation, Glide scope Ranger, Pre hospital
- Medical subject headings
- Heart Arrest, Respiratory Distress Syndrome, Shock, Drug-Related Side Effects and Adverse Reactions, Trauma, Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classical intubationDevice
Classical intubation
GLIDESCOPEDevice
GLIDESCOPE intubation
| Study group | Role | What they receive |
|---|---|---|
| 1: Classical intubation | Active comparator | Not described Receives: Device: Classical intubation |
| 2: Glidescope intubation | Experimental | Not described Receives: Device: GLIDESCOPE |
What is being measured
The primary outcome is the main question the study is designed to answer.
IDS score in each group
Measured: during the intubation
Secondary outcomes (7)
Vomit / regurgitation or inhalation per-procedure
Measured: during the intubation
Dental or throat traumatism
Measured: during the intubation
Broncho/laryngospasm
Measured: during the intubation
Hypoxia
Measured: per intubation
Hemodynamic instability
Measured: per intubation
Inhalation pneumonia
Measured: within 24 hours following the inclusion
Failure of intubate
Measured: during the intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Sébastien GALLULA, Ph, Principal investigator, Assistance Publique - Hôpitaux de ParisPatrick PLAISANCE, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01374061
- Sponsor's protocol ID
- P100205
- Other IDs
- 2010-A01512-37
- Acronym
- EVE
- Status last verified
- May 2014
- First submitted
- 25 May 2011
- Last updated
- 8 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre Hospital Evaluation of Video Laryngoscopy : a Comparative Study of Macintosh and GLIDESCOPE Ranger®
- ClinicalTrials.gov ID
- NCT01374061
- Acronym / sponsor ID
- EVE / P100205
- Conditions
- Cardiac Arrest, Respiratory Distress Syndrome, Shock, Acute Post-trauma Stress State, Drug Toxicity, Trauma, Nervous System
- Keywords
- Emergency intubation, Glide scope Ranger, Pre hospital
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Jun 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 15 Jun 2011 (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 objective of this work is to compare standard intubation with video laryngoscope (Glide scope Ranger ) in French pre hospital multicentric study.
Detailed description
Introduction: In France, patients in critical status brought to hospital by emergency physicians and nurses experimented in tracheal intubation. It is an invasive act allowing a protection of airways and an optimal oxygenation of the patients in distress. The reference technique is the direct laryngoscopy by Macintosh . Corresponding data shows that a video laryngoscope - GLIDESCOPE laryngoscope - improve the conditions of intubation in the surgical unit thanks to a better display(visualization) of the opening. A derived device for pre hospital emergency units (GLIDESCOPE Ranger®) deserves to be compared with the classic laryngoscopy in emergency conditions.
Objectives: compare the emergency intubation in Pre hospital meadow by Glide Scope Ranger with regard to the classic method
Progress of the study: the patients will be included by emergency physicians working in out of hospital teams of 3 major hospitals of Paris. The patients will be randomized in 2 groups: 1 group classic laryngoscopy (group 1) and a group Glide scope Ranger (group 2). The score IDS will be compared for every group as well as the arisen of a complication during the procedure. The consent will be collected on the place or during the hospitalization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Classical intubation | Active comparator | Device: Classical intubation |
| 2: Glidescope intubation | Experimental | Device: GLIDESCOPE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients of more than 18 years old
- requiring an intubation
- by medical out of hospital emergency operators
- medical insurance
- Consent signed
Key exclusion criteria (3 listed)
- Age <18, pregnant women
- Refusal of consent or inability for understanding study
- small mouth opening makes it impossible intubate
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 |
|---|---|---|
| Classical intubationClassical intubation | Device | 1: Classical intubation |
| GLIDESCOPEGLIDESCOPE intubation | Device | 2: Glidescope intubation |
Primary outcome
IDS score in each group
Time frame: during the intubation
7 secondary outcomes
Vomit / regurgitation or inhalation per-procedure
Time frame: during the intubation
Dental or throat traumatism
Time frame: during the intubation
Broncho/laryngospasm
Time frame: during the intubation
Hypoxia
Time frame: per intubation
Hemodynamic instability
Time frame: per intubation
Inhalation pneumonia
Time frame: within 24 hours following the inclusion
Failure of intubate
Time frame: during the intubation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2014.
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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.
Sébastien GALLULA, Ph principal investigator
Assistance Publique - Hôpitaux de Paris
Patrick PLAISANCE, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Classical intubation and GLIDESCOPE in people with Cardiac Arrest and Respiratory Distress Syndrome, run by Assistance Publique - Hôpitaux de Paris.
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 5 inclusion and 3 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: withdrawn, as of the sponsor's last update on 8 May 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
IDS score in each group (time frame: during the intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2014.