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Completed

NCT Number: NCT01532063

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

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.

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Key information

Conditions

Difficult Intubation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Montpellier, Saint Eloi

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

INTUBATION IN INTENSIVE CARE UNIT

Procedure

Standard intubation procedure used in Intensive Care Unit

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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.

  3. Incidence of difficult intubation in ICU

    Time frame: up to day 28

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: FRIDA-Rea

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 13, 2012
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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