Clinical trial NCT01374061: Pre Hospital Evaluation of Video Laryngoscopy
Official title: Pre Hospital Evaluation of Video Laryngoscopy : a Comparative Study of Macintosh and GLIDESCOPE Ranger®
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
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
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2011-06-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: IDS score in each group
timeFrame: during the intubation
Secondary outcomes:
measure: Vomit / regurgitation or inhalation per-procedure
timeFrame: during the intubation
measure: Dental or throat traumatism
timeFrame: during the intubation
measure: Broncho/laryngospasm
timeFrame: during the intubation
measure: Hypoxia
timeFrame: per intubation
measure: Hemodynamic instability
timeFrame: per intubation
measure: Inhalation pneumonia
timeFrame: within 24 hours following the inclusion
measure: Failure of intubate
timeFrame: during the intubation
Other outcomes:
Locations:
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Sébastien GALLULA, Ph
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Patrick PLAISANCE, MD, PhD
role: STUDY_DIRECTOR
References: