NCT01374061

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2011

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2011

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 15, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 8, 2014

Status Verified

May 1, 2014

Enrollment Period

1.5 years

First QC Date

May 25, 2011

Last Update Submit

May 7, 2014

Conditions

Cardiac ArrestRespiratory Distress SyndromeShockAcute Post-trauma Stress StateDrug ToxicityTrauma, Nervous System

Keywords

Emergency intubationGlide scope RangerPre hospital

Outcome Measures

Primary Outcomes (1)

  • IDS score in each group

    during the intubation

Secondary Outcomes (7)

  • Vomit / regurgitation or inhalation per-procedure

    during the intubation

  • Dental or throat traumatism

    during the intubation

  • Broncho/laryngospasm

    during the intubation

  • Hypoxia

    per intubation

  • Hemodynamic instability

    per intubation

  • +2 more secondary outcomes

Study Arms (2)

1: Classical intubation

ACTIVE COMPARATOR
Device: Classical intubation

2: Glidescope intubation

EXPERIMENTAL
Device: GLIDESCOPE

Interventions

Classical intubationDEVICE

Classical intubation

1: Classical intubation
GLIDESCOPEDEVICE

GLIDESCOPE intubation

2: Glidescope intubation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients of more than 18 years old
  • requiring an intubation
  • by medical out of hospital emergency operators
  • medical insurance
  • Consent signed

You may not qualify if:

  • Age \<18, pregnant women
  • Refusal of consent or inability for understanding study
  • small mouth opening makes it impossible intubate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart ArrestRespiratory Distress SyndromeShockDrug-Related Side Effects and Adverse ReactionsTrauma, Nervous System

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesRespiration DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsChemically-Induced DisordersNervous System DiseasesWounds and Injuries

Study Officials

  • Sébastien GALLULA, Ph

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

  • Patrick PLAISANCE, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2011

First Posted

June 15, 2011

Study Start

June 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

May 8, 2014

Record last verified: 2014-05