Pre Hospital Evaluation of Video Laryngoscopy (EVE)
Primary Purpose
Cardiac Arrest, Respiratory Distress Syndrome, Shock
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Classical intubation
GLIDESCOPE
Sponsored by
About this trial
This is an interventional treatment trial for Cardiac Arrest focused on measuring Emergency intubation, Glide scope Ranger, Pre hospital
Eligibility Criteria
Inclusion Criteria:
- patients of more than 18 years old
- requiring an intubation
- by medical out of hospital emergency operators
- medical insurance
- Consent signed
Exclusion Criteria:
- Age <18, pregnant women
- Refusal of consent or inability for understanding study
- small mouth opening makes it impossible intubate
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1: Classical intubation
2: Glidescope intubation
Arm Description
Outcomes
Primary Outcome Measures
IDS score in each group
Secondary Outcome Measures
Vomit / regurgitation or inhalation per-procedure
Dental or throat traumatism
Broncho/laryngospasm
Hypoxia
Hemodynamic instability
Inhalation pneumonia
Failure of intubate
Full Information
NCT ID
NCT01374061
First Posted
May 25, 2011
Last Updated
May 7, 2014
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Ministry of Health, France
1. Study Identification
Unique Protocol Identification Number
NCT01374061
Brief Title
Pre Hospital Evaluation of Video Laryngoscopy
Acronym
EVE
Official Title
Pre Hospital Evaluation of Video Laryngoscopy : a Comparative Study of Macintosh and GLIDESCOPE Ranger®
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor decision
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Ministry of Health, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Respiratory Distress Syndrome, Shock, Acute Post-trauma Stress State, Drug Toxicity, Trauma, Nervous System
Keywords
Emergency intubation, Glide scope Ranger, Pre hospital
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1: Classical intubation
Arm Type
Active Comparator
Arm Title
2: Glidescope intubation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Classical intubation
Intervention Description
Classical intubation
Intervention Type
Device
Intervention Name(s)
GLIDESCOPE
Intervention Description
GLIDESCOPE intubation
Primary Outcome Measure Information:
Title
IDS score in each group
Time Frame
during the intubation
Secondary Outcome Measure Information:
Title
Vomit / regurgitation or inhalation per-procedure
Time Frame
during the intubation
Title
Dental or throat traumatism
Time Frame
during the intubation
Title
Broncho/laryngospasm
Time Frame
during the intubation
Title
Hypoxia
Time Frame
per intubation
Title
Hemodynamic instability
Time Frame
per intubation
Title
Inhalation pneumonia
Time Frame
within 24 hours following the inclusion
Title
Failure of intubate
Time Frame
during the intubation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients of more than 18 years old
requiring an intubation
by medical out of hospital emergency operators
medical insurance
Consent signed
Exclusion Criteria:
Age <18, pregnant women
Refusal of consent or inability for understanding study
small mouth opening makes it impossible intubate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sébastien GALLULA, Ph
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patrick PLAISANCE, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Pre Hospital Evaluation of Video Laryngoscopy
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