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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Difficult Intubation

Intervention / Treatment
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* Procedure: INTUBATION IN INTENSIVE CARE UNIT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: INTUBATION<br>Subjects intubed in Intensive Care Unit | Procedure: INTUBATION IN INTENSIVE CARE UNIT<br>* Standard intubation procedure used in Intensive Care Unit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Incidence of difficult intubation in ICU |  | up to day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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