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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01532063
First received: February 8, 2012
Last updated: March 14, 2013
Last verified: March 2013
  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: Open Label
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University Hospital, Montpellier

Additional 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: UF 8819
Study First Received: February 8, 2012
Last Updated: March 14, 2013
Health Authority: France: Committee for the Protection of Personnes

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

ClinicalTrials.gov processed this record on October 01, 2014