NCT03486171

Brief Summary

In prehospital emergency setting, tracheal intubation is a frequent procedure (8% of interventions). Its objective is to control and protect upper airways and to optimize ventilation and oxygenation in patients with life-threatening distress. Intubation is a technical procedure which is associated with few difficulties with, in rare cases, the impossibility to do it. There are specificities of the out-of-hospital emergency with some risk factors that have been recognized in this context as well as the impossibility of assessing predictive factors of difficult intubation linked to the patient. The objective of the investigators was to describe the quality of tracheal intubation in prehospital emergency setting.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

5 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 3, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

April 3, 2018

Status Verified

March 1, 2018

Enrollment Period

1.2 years

First QC Date

January 24, 2018

Last Update Submit

March 26, 2018

Conditions

Keywords

difficult intubationprehospital emergencyrisk factors

Outcome Measures

Primary Outcomes (1)

  • Difficult intubation rate

    Difficult intubation is defined with an Intubation Difficult Scale score \> 5; Intubation Difficult Sale (IDS) is ranged from 0 (easy intubation) to infinity (impossibility to intubate trachea).

    One hour

Secondary Outcomes (3)

  • Risk factors of difficult intubation

    one hour

  • Patient characteristics

    one hour

  • Events during and after intubation

    one hour

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients with life-threatening distress requiring emergency intubation.

You may qualify if:

  • all patients intubated by Emergency Medical System (EMS) team

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHU DE BORDEAUX- Hôpital PELLEGRIN - SAMU-SMUR 33

Bordeaux, 33000, France

RECRUITING

Aphp, Hopital Raymond Poincare - Samu-Smur 92

Garches, 92380, France

RECRUITING

Ch Garges Les Gonesses

Garges-lès-Gonesse, 95141, France

RECRUITING

Chu de Grenoble - Samu-Smur 38

Grenoble, 38000, France

RECRUITING

Ch de Perigueux - Samu-Smur 24

Périgueux, 24000, France

RECRUITING

Study Officials

  • MICHEL GALINSKI

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

MICHEL GALINSKI, M.D; Ph.D.

CONTACT

MICHEL GALINSKI

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 24, 2018

First Posted

April 3, 2018

Study Start

March 1, 2017

Primary Completion

May 31, 2018

Study Completion

September 1, 2018

Last Updated

April 3, 2018

Record last verified: 2018-03

Locations