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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01532063
First Posted: February 13, 2012
Last Update Posted: April 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Montpellier
  Purpose
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.

Condition Intervention
Difficult Intubation Procedure: INTUBATION IN INTENSIVE CARE UNIT

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Risk Factors of Difficult Intubation and Related Complications in Adults in Intensive Care Units(ICU)

Further study details as provided by University Hospital, Montpellier:

Primary Outcome 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 Outcome 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 ]

Enrollment: 1400
Study Start Date: October 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
INTUBATION
Subjects intubed in Intensive Care Unit
Procedure: INTUBATION IN INTENSIVE CARE UNIT
Standard intubation procedure used in Intensive Care Unit

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
France
University Hospital of Montpellier, Saint Eloi
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Samir SJ JABER, MD,PhD University Hospital, Montpellier
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01532063     History of Changes
Other Study ID Numbers: 8819
2011-A001122-39 ( Other Identifier: RCB number )
First Submitted: February 8, 2012
First Posted: February 13, 2012
Last Update Posted: April 21, 2017
Last Verified: March 2013

Keywords provided by University Hospital, Montpellier:
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