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

University Hospital Center (CHU)

Status: Completed

Conditions: Difficult Intubation

Treatments: Procedure: INTUBATION IN INTENSIVE CARE UNIT

Study type: Interventional

Funder types: Other

Identifiers

NCT01532063

8819

2012-A00651-42 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1,400 participants in 1 patient group

INTUBATION

Other group

Description:

Subjects intubed in Intensive Care Unit

Treatment:

Procedure: INTUBATION IN INTENSIVE CARE UNIT