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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01532063
Other study ID # 8819
Secondary ID 2011-A001122-39
Status Completed
Phase N/A
First received February 8, 2012
Last updated April 20, 2017
Start date October 2011
Est. completion date April 2012

Study information

Verified date March 2013
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1400
Est. completion date April 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
INTUBATION IN INTENSIVE CARE UNIT
Standard intubation procedure used in Intensive Care Unit

Locations

Country Name City State
France University Hospital of Montpellier, Saint Eloi Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difficult intubation According to ASA criteria, difficult intubation is measured by attempts lasting more than 10 min or more than two attempts until to 10 minutes
Secondary Complications of intubation in ICU 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
up to one hour after intubation
Secondary Mortality at 28 days after difficult intubation Survival status at Day 28 or date of death if patient dead before. up to 28 days after difficult intubation
Secondary Incidence of difficult intubation in ICU up to day 28
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