Evaluation of the Bonfils Fiberscope for Predicted Difficult Intubation in Awake Patients With Ear, Nose, and Throat (ENT) Cancer (INVIBO)

Phase 2

Completed

• Conditions: Carcinoma

• Registration Number: NCT01070537
• Lead Sponsor: Centre Leon Berard

Brief Summary

The Bonfils intubation fiberscope (BF), a rigid medical device with a curved tip, is exclusively used in anesthesiology for orotracheal intubation (OTI). The objective of the study was to evaluate the feasibility and the tolerance of an intubation procedure realized by means of the BF (BFI) in awake adult patients with predicted difficult intubation (PDI), in the context of ENT cancer surgery.

The intubation is performed under local anesthesia (either nasal, oral, or intercricothyroidal) and sedation using Remifentanyl (AIVOC) with spontaneous ventilation. The primary endpoint is the rate of BFI meeting quality requirements: the procedure must be both successful (≤ 2 attempts and duration \< 180 sec) and well tolerated (Fahey score \< 2). The secondary endpoints include the difficulties met by the operator during the BFI and patient's perception of the intubation procedure, evaluated in the recovery room and 7 days after the intervention. Sample size is calculated using a one-stage Fleming design with p0=80%, p1=95%, alpha=5% and 80% power, for a total of 32 evaluable patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2010-02
• Study First Submitted: 2010-02-15
• Study First Submitted QC: 2010-02-17
• Last Update Submitted: 2010-02-17
• Study First Posted: 2010-02-18
• Last Update Posted: 2010-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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).	180 sec after the beginning of the intubation

Secondary Outcome Measures

Name	Time	Method
Number of well-tolerated BFI procedures	At the end of the intubation
Duration of the intubation procedure among patients with a successful BFI (≤ 2 attempts and duration < 180 sec)	At the end of the intubation
Frequency and type of difficulties met by the operator	At the end of the intubation
Frequency and type of adverse events experienced by the patient	At the end of the intubation
Patient's perception of the intubation procedure	In the recovery room and 7 days after the intubation

Trial Locations

Locations (1)

Centre Léon Bérard; 🇫🇷 Lyon Cedex 08, France