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

Risk Factors of Difficult Intubation and Related Complications in Adults in Intensive Care Units(ICU)

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.

Study Overview

• Status: Completed
• Conditions: Difficult Intubation
• Intervention / Treatment: Procedure: INTUBATION IN INTENSIVE CARE UNIT

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 1400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • University Hospital of Montpellier, Saint Eloi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: INTUBATION; Subjects intubed in Intensive Care Unit	Procedure: INTUBATION IN INTENSIVE CARE UNIT; Standard intubation procedure used in Intensive Care Unit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications of intubation in ICU	Respiratory (inhalation, oesophageal intubation, SpO2<80%); Hemodynamic(SAP<65 mm Hg, elevated or low cardiac frequency,rythm troubles, heart attack),; Neurologic (agitation),; Local (dental trauma, laryngal trauma),; Death; Complications occuring during one hour after intubation: respiratory (major desaturation: SpO2<80%, pneumothorax, persistent hypoxia with SpO2<80%), hemodynamic (persistent hypotension: SAP<90 mm Hg despite of vascular filling, rythm troubles, heart attack, introduction or majoration of amines posology), neurologic(agitation), death	up to one hour after intubation
Mortality at 28 days after difficult intubation	Survival status at Day 28 or date of death if patient dead before.	up to 28 days after difficult intubation
Incidence of difficult intubation in ICU		up to day 28

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Samir SJ JABER, MD,PhD, University Hospital, Montpellier

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: February 8, 2012
• First Submitted That Met QC Criteria: February 10, 2012
• First Posted (Estimated): February 13, 2012

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 26, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Incidence; Risk factors; Complications; Difficult intubation; Intensive care units; Intubation in Intensive Care Unit; More than 2 attempts of intubation; Intubation attempts lasting more than 10 minutes
• Additional Relevant MeSH Terms: Investigative Techniques; Therapeutics; Health Care Facilities Workforce and Services; Health Facilities; Hospital Units; Intubation; Intensive Care Units
• Other Study ID Numbers: 8819; 2012-A00651-42 (Other Identifier: RCB number)