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Pre Hospital Evaluation of Video Laryngoscopy (EVE)

This study has been withdrawn prior to enrollment.
(Sponsor decision)
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01374061
First received: May 25, 2011
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

The objective of this work is to compare standard intubation with video laryngoscope (Glide scope Ranger ) in French pre hospital multicentric study.


Condition Intervention Phase
Cardiac Arrest
Respiratory Distress Syndrome
Shock
Acute Post-trauma Stress State
Drug Toxicity
Trauma, Nervous System
Device: Classical intubation
Device: GLIDESCOPE
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pre Hospital Evaluation of Video Laryngoscopy : a Comparative Study of Macintosh and GLIDESCOPE Ranger®

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • IDS score in each group [ Time Frame: during the intubation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Vomit / regurgitation or inhalation per-procedure [ Time Frame: during the intubation ] [ Designated as safety issue: Yes ]
  • Dental or throat traumatism [ Time Frame: during the intubation ] [ Designated as safety issue: Yes ]
  • Broncho/laryngospasm [ Time Frame: during the intubation ] [ Designated as safety issue: Yes ]
  • Hypoxia [ Time Frame: per intubation ] [ Designated as safety issue: Yes ]
  • Hemodynamic instability [ Time Frame: per intubation ] [ Designated as safety issue: Yes ]
  • Inhalation pneumonia [ Time Frame: within 24 hours following the inclusion ] [ Designated as safety issue: Yes ]
  • Failure of intubate [ Time Frame: during the intubation ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: June 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1: Classical intubation
NA
Device: Classical intubation
Classical intubation
Experimental: 2: Glidescope intubation
NA
Device: GLIDESCOPE
GLIDESCOPE intubation

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01374061

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Investigators
Principal Investigator: Sébastien GALLULA, Ph Assistance Publique - Hôpitaux de Paris
Study Director: Patrick PLAISANCE, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01374061     History of Changes
Other Study ID Numbers: P100205, 2010-A01512-37
Study First Received: May 25, 2011
Last Updated: May 7, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Emergency intubation
Glide scope Ranger
Pre hospital

Additional relevant MeSH terms:
Heart Arrest
Respiratory Distress Syndrome, Newborn
Stress Disorders, Post-Traumatic
Trauma, Nervous System
Anxiety Disorders
Cardiovascular Diseases
Heart Diseases
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Mental Disorders
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Stress Disorders, Traumatic
Wounds and Injuries

ClinicalTrials.gov processed this record on November 24, 2014