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

February 8, 2012
March 14, 2013
October 2011
April 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01532063 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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)

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Difficult Intubation
Procedure: INTUBATION IN INTENSIVE CARE UNIT
Standard intubation procedure used in Intensive Care Unit
INTUBATION
Subjects intubed in Intensive Care Unit
Intervention: Procedure: INTUBATION IN INTENSIVE CARE UNIT
De Jong A, Molinari N, Terzi N, Mongardon N, Arnal JM, Guitton C, Allaouchiche B, Paugam-Burtz C, Constantin JM, Lefrant JY, Leone M, Papazian L, Asehnoune K, Maziers N, Azoulay E, Pradel G, Jung B, Jaber S; AzuRéa Network for the Frida-Réa Study Group. Early identification of patients at risk for difficult intubation in the intensive care unit: development and validation of the MACOCHA score in a multicenter cohort study. Am J Respir Crit Care Med. 2013 Apr 15;187(8):832-9. doi: 10.1164/rccm.201210-1851OC.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1400
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01532063
UF 8819
No
University Hospital, Montpellier
University Hospital, Montpellier
Not Provided
Principal Investigator: Samir SJ JABER, MD,PhD University Hospital, Montpellier
University Hospital, Montpellier
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP