Risk Factors of Difficult Intubation and Related Complications in Adults in Intensive Care Units: FRIDA-Rea
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Risk Factors of Difficult Intubation and Related Complications in Adults in Intensive Care Units(ICU)|
- Difficult intubation [ Time Frame: until to 10 minutes ] [ Designated as safety issue: No ]According to ASA criteria, difficult intubation is measured by attempts lasting more than 10 min or more than two attempts
- Complications of intubation in ICU [ Time Frame: up to one hour after intubation ] [ Designated as safety issue: No ]
- 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),
- 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 [ Time Frame: up to 28 days after difficult intubation ] [ Designated as safety issue: No ]Survival status at Day 28 or date of death if patient dead before.
- Incidence of difficult intubation in ICU [ Time Frame: up to day 28 ] [ Designated as safety issue: No ]
|Study Start Date:||October 2011|
|Study Completion Date:||April 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Subjects intubed in Intensive Care Unit
Procedure: INTUBATION IN INTENSIVE CARE UNIT
Standard intubation procedure used in Intensive Care Unit
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01532063
|University Hospital of Montpellier, Saint Eloi|
|Montpellier, France, 34295|
|Principal Investigator:||Samir SJ JABER, MD,PhD||University Hospital, Montpellier|