Risk Factors of Difficult Intubation and Related Complications in Adults in Intensive Care Units: FRIDA-Rea (FRIDA-Rea)
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|ClinicalTrials.gov Identifier: NCT01532063|
Recruitment Status : Completed
First Posted : February 13, 2012
Last Update Posted : April 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Difficult Intubation||Procedure: INTUBATION IN INTENSIVE CARE UNIT||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1400 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Risk Factors of Difficult Intubation and Related Complications in Adults in Intensive Care Units(ICU)|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
Subjects intubed in Intensive Care Unit
Procedure: INTUBATION IN INTENSIVE CARE UNIT
Standard intubation procedure used in Intensive Care Unit
- Difficult intubation [ Time Frame: until to 10 minutes ]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 ]
- 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 ]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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01532063
|University Hospital of Montpellier, Saint Eloi|
|Montpellier, France, 34295|
|Principal Investigator:||Samir SJ JABER, MD,PhD||University Hospital, Montpellier|