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

Overview

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 Title of Study: “Risk Factors of Difficult Intubation and Related Complications in Adults in Intensive Care Units(ICU)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2012

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.

Interventions

  • Procedure: INTUBATION IN INTENSIVE CARE UNIT
    • Standard intubation procedure used in Intensive Care Unit

Arms, Groups and Cohorts

  • Other: INTUBATION
    • Subjects intubed in Intensive Care Unit

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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), 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Montpellier
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Samir SJ JABER, MD,PhD, Principal Investigator, University Hospital, Montpellier

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