INVIBO: Evaluation of the Feasibility and Tolerance of an Intubation Procedure Performed by Means of the Bonfils Fiberscope in Awake Patients With Predicted Difficult Intubation in the Context of ENT Cancer Surgery
18 Years
N/A
Both
Carcinoma
Trial Information
INVIBO: Evaluation of the Feasibility and Tolerance of an Intubation Procedure Performed by Means of the Bonfils Fiberscope in Awake Patients With Predicted Difficult Intubation in the Context of ENT Cancer Surgery
Inclusion Criteria:
- Male or female patients aged ≥ 18 years
- Requiring a surgical intervention for an ENT carcinoma
- Presenting with a PDI defined either as an Arne Score > 11, or a previous history of
DI or by the surgeon's judgment.
- Able to understand, read and write French
- Signed, written informed consent
Exclusion Criteria:
- Impossible mask ventilation
- Patient with a laryngeal stridor indicative of upper airway stenosis
- Patient requiring an intubation by nasal route
- Glasgow score < 12
- BMI > 35
- Pregnant or lactating women
- Documented history of cognitive or psychiatric disorders
- Difficult follow-up
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment
Outcome Measure:
The rate of BFI meeting quality requirements: the procedure must be successful on the one hand (≤ 2 attempts and duration < 180 sec); and well tolerated on the other hand (Fahey score < 2).
Outcome Time Frame:
180 sec after the beginning of the intubation
Safety Issue:
Yes
Principal Investigator
Jean-Edgard Mazères, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Centre Léon Bérard
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
INVIBO
NCT ID:
NCT01070537
Start Date:
February 2008
Completion Date:
April 2009
Related Keywords:
- Carcinoma
- Otolaryngology
- Equipment and Supplies
- Intubation
- Carcinoma
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