Tracheal Intubation and Prehospital Emergency Setting

NCT ID: NCT03486171

Last Updated: 2018-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-01

Study Completion Date

2018-09-01

Brief Summary

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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.

Detailed Description

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National and international guidelines have the objective to optimize the airway management modalities and to minimize the risk of complications in relation to this procedure. In contrast to the operating-room where intubation is performed daily in standardized conditions, in prehospital emergency setting, the environment and circumstances are variable and have an impact on the gesture as has been demonstrated. However, there are few studies about this issue, and these one are relatively ancients although that orotracheal intubation procedures in emergency are now well defined and that the algorithms for the management of difficult intubation have been well diffused in the emergency area these last 10 years. The last study about this topic has been published in 2012 involving more than 600 patients included between 2008 and 2010.

Difficult intubation rate, defined with a number of attempts over 2 or the use of an alternative technic was 11%. Another study with more than 2000 patients had found a rate of 6%. A study comparing the intubation difficulty scale score between two types of blades in 800 patients had found a rate of difficult intubation from 9 to 12%. The algorithms of the management of difficult intubation were largely based on the result of studies performed by anesthesiologists in operating ward. The objective will be to describe the quality of intubation and to measure risk factors of difficult intubation. The investigators are going to collect data about all patients intubated in prehospital emergency setting with the objective to measure the difficult intubation rate and to describe variables associated with difficult intubation. The follow up will be restricted to the area of prehospital emergency setting.

Conditions

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Tracheal Intubation Morbidity Emergency Medicine

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* none
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Michel GALINSKI

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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MICHEL GALINSKI

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

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CHU DE BORDEAUX- Hôpital PELLEGRIN - SAMU-SMUR 33

Bordeaux, , France

Site Status RECRUITING

Aphp, Hopital Raymond Poincare - Samu-Smur 92

Garches, , France

Site Status RECRUITING

Ch Garges Les Gonesses

Garges-lès-Gonesse, , France

Site Status RECRUITING

Chu de Grenoble - Samu-Smur 38

Grenoble, , France

Site Status RECRUITING

Ch de Perigueux - Samu-Smur 24

Périgueux, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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MICHEL GALINSKI, M.D; Ph.D.

Role: CONTACT

+335.56.79.48.26

MICHEL GALINSKI

Role: CONTACT

+33678549415

Facility Contacts

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MICHEL GALINSKI, M.D, Ph.D

Role: primary

+335.56.79.48.26

PAUL-GEORGES REUTER

Role: primary

MIRKO RUSCEV

Role: primary

GUILLAUME DEBATY

Role: primary

JEAN-PAUL LORENDEAU

Role: primary

Other Identifiers

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CHUBX-URG-01

Identifier Type: -

Identifier Source: org_study_id

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