Clinical trial NCT01532063: Risk Factors of Difficult Intubation and Related Complications in Adults in Intensive Care Units: FRIDA-Rea
Official title: Risk Factors of Difficult Intubation and Related Complications in Adults in Intensive Care Units(ICU)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Difficult Intubation
Keywords: Difficult intubation
Intensive care units
Risk factors
Incidence
Complications
Intubation in Intensive Care Unit
More than 2 attempts of intubation
Intubation attempts lasting more than 10 minutes
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2012-02-13
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difficult intubation
timeFrame: until to 10 minutes
Secondary outcomes:
measure: Complications of intubation in ICU
timeFrame: up to one hour after intubation
measure: Mortality at 28 days after difficult intubation
timeFrame: up to 28 days after difficult intubation
measure: Incidence of difficult intubation in ICU
timeFrame: up to day 28
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital of Montpellier, Saint Eloi
Study officials:
affiliation: University Hospital, Montpellier
name: Samir SJ JABER, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.