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

Not Applicable

Completed

• Conditions: Difficult Intubation
• Interventions: Procedure: INTUBATION IN INTENSIVE CARE UNIT

• Registration Number: NCT01532063
• Lead Sponsor: University Hospital, Montpellier

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.

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 Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-02-08
• Study First Submitted QC: 2012-02-10
• Study First Posted: 2012-02-13
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2013-03
• Last Update Submitted: 2017-04-20
• Last Update Posted: 2017-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
INTUBATION	INTUBATION IN INTENSIVE CARE UNIT	Subjects intubed in Intensive Care Unit

Primary Outcome Measures

Name	Time	Method
Difficult intubation	until to 10 minutes	According to ASA criteria, difficult intubation is measured by attempts lasting more than 10 min or more than two attempts

Secondary Outcome Measures

Name	Time	Method
Complications of intubation in ICU	up to one hour after intubation	* 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
Mortality at 28 days after difficult intubation	up to 28 days after difficult intubation	Survival status at Day 28 or date of death if patient dead before.
Incidence of difficult intubation in ICU	up to day 28

Trial Locations

Locations (1)

University Hospital of Montpellier, Saint Eloi; 🇫🇷 Montpellier, France