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

Difficult Intubation Clinical Trial

— FRIDA-Rea  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01532063
• Other study ID #: 8819
• Secondary ID: 2011-A001122-39
• Status: Completed
• Phase: N/A
• First received: February 8, 2012
• Last updated: April 20, 2017
• Start date: October 2011
• Est. completion date: April 2012

Study information

• Verified date: March 2013
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1400
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Difficult Intubation

Intervention

Procedure:
• INTUBATION IN INTENSIVE CARE UNIT
Standard intubation procedure used in Intensive Care Unit

Locations

Country	Name	City	State
France	University Hospital of Montpellier, Saint Eloi	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Incidence of difficult intubation in ICU		up to day 28