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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01532063
Acronym
FRIDA-Rea
Enrollment
1400
Registered
2012-02-13
Start date
2011-10-31
Completion date
2012-04-30
Last updated
2025-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Difficult Intubation

Keywords

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

Brief summary

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

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

PROCEDUREINTUBATION IN INTENSIVE CARE UNIT

Standard intubation procedure used in Intensive Care Unit

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Difficult intubationuntil to 10 minutesAccording to ASA criteria, difficult intubation is measured by attempts lasting more than 10 min or more than two attempts

Secondary

MeasureTime frameDescription
Complications of intubation in ICUup 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 intubationup to 28 days after difficult intubationSurvival status at Day 28 or date of death if patient dead before.
Incidence of difficult intubation in ICUup to day 28

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026