Risk Factors of Difficult Intubation and Related Complications in Adults in Intensive Care Units: FRIDA-Rea

NCT ID: NCT01532063

Last Updated: 2025-10-02

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

COMPLETED

Clinical Phase

NA

Total Enrollment

1400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-04-30

Brief Summary

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Difficult intubation is challenging in intensive care units. There are limited data regarding risk factors of difficult intubation in ICU. The primary purpose of the investigators study is to assess the risk factors of difficult airway in adults in ICU.

Detailed Description

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PURPOSE: Intubation in ICU strongly differs from intubation in operative rooms. The results of studies about risk factors of difficult intubation performed in operative rooms cannot therefore be extrapolated directly to ICU.

The primary purpose of this trial (cf Part "Design" of this registration) is "other" and more particularly "Prognosis" because it is is an assessment of risk factors of difficult airway in intensive care units.

DESIGN AND METHODOLOGY: This is an open prospective multicentric study of intubation in ICU in more than 50 centres. Consecutive intubations will be included in each centre, in order to reach the sample size required (at least 1000 procedures intubations). The usual risk factors of difficult intubation in operative rooms, the demographic parameters and the complications of intubation will be assessed, as well as survival status at 28 days.

Conditions

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Difficult Intubation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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INTUBATION

Subjects intubed in Intensive Care Unit

Group Type OTHER

INTUBATION IN INTENSIVE CARE UNIT

Intervention Type PROCEDURE

Standard intubation procedure used in Intensive Care Unit

Interventions

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INTUBATION IN INTENSIVE CARE UNIT

Standard intubation procedure used in Intensive Care Unit

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* More or equal to 18 years old
* Men and women
* Informed patient
* Affiliated or benefit from an disease insurance
* Available for a 28 days follow-up
* Intubated patients in Intensive Care Unit

Exclusion Criteria

* Law protected patients
* Opposed to participate to study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samir SJ JABER, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

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University Hospital of Montpellier, Saint Eloi

Montpellier, , France

Site Status

Countries

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France

References

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Perbet S, De Jong A, Delmas J, Futier E, Pereira B, Jaber S, Constantin JM. Incidence of and risk factors for severe cardiovascular collapse after endotracheal intubation in the ICU: a multicenter observational study. Crit Care. 2015 Jun 18;19(1):257. doi: 10.1186/s13054-015-0975-9.

Reference Type DERIVED
PMID: 26084896 (View on PubMed)

De Jong A, Molinari N, Pouzeratte Y, Verzilli D, Chanques G, Jung B, Futier E, Perrigault PF, Colson P, Capdevila X, Jaber S. Difficult intubation in obese patients: incidence, risk factors, and complications in the operating theatre and in intensive care units. Br J Anaesth. 2015 Feb;114(2):297-306. doi: 10.1093/bja/aeu373. Epub 2014 Nov 27.

Reference Type DERIVED
PMID: 25431308 (View on PubMed)

De Jong A, Molinari N, Terzi N, Mongardon N, Arnal JM, Guitton C, Allaouchiche B, Paugam-Burtz C, Constantin JM, Lefrant JY, Leone M, Papazian L, Asehnoune K, Maziers N, Azoulay E, Pradel G, Jung B, Jaber S; AzuRea Network for the Frida-Rea Study Group. Early identification of patients at risk for difficult intubation in the intensive care unit: development and validation of the MACOCHA score in a multicenter cohort study. Am J Respir Crit Care Med. 2013 Apr 15;187(8):832-9. doi: 10.1164/rccm.201210-1851OC.

Reference Type DERIVED
PMID: 23348979 (View on PubMed)

Other Identifiers

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2012-A00651-42

Identifier Type: OTHER

Identifier Source: secondary_id

8819

Identifier Type: -

Identifier Source: org_study_id

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