NCT01532063

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 13, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

February 8, 2012

Last Update Submit

September 26, 2025

Conditions

Difficult Intubation

Keywords

Difficult intubationIntensive care unitsRisk factorsIncidenceComplicationsIntubation in Intensive Care UnitMore than 2 attempts of intubationIntubation attempts lasting more than 10 minutes

Outcome Measures

Primary Outcomes (1)

  • Difficult intubation

    According to ASA criteria, difficult intubation is measured by attempts lasting more than 10 min or more than two attempts

    until to 10 minutes

Secondary Outcomes (3)

  • Complications of intubation in ICU

    up to one hour after intubation

  • Mortality at 28 days after difficult intubation

    up to 28 days after difficult intubation

  • Incidence of difficult intubation in ICU

    up to day 28

Study Arms (1)

INTUBATION

OTHER

Subjects intubed in Intensive Care Unit

Procedure: INTUBATION IN INTENSIVE CARE UNIT

Interventions

INTUBATION IN INTENSIVE CARE UNITPROCEDURE

Standard intubation procedure used in Intensive Care Unit

INTUBATION

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Law protected patients
  • Opposed to participate to study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Montpellier, Saint Eloi

Montpellier, 34295, France

Location

Related Publications (3)

  • 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.

    PMID: 26084896DERIVED

  • 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.

    PMID: 25431308DERIVED

  • 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.

    PMID: 23348979DERIVED

MeSH Terms

Interventions

IntubationIntensive Care Units

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative TechniquesHospital UnitsHealth FacilitiesHealth Care Facilities Workforce and Services

Study Officials

  • Samir SJ JABER, MD,PhD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2012

First Posted

February 13, 2012

Study Start

October 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

October 2, 2025

Record last verified: 2025-09

Locations

FR(1)