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

NCT01070537 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2010-02-18

No results posted yet for this study

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.

Conditions

  • Carcinoma

Interventions

DEVICE

Bonfils fiberscope intubation

Sponsors & Collaborators

  • Centre Leon Berard

    lead OTHER

Principal Investigators

  • Jean-Edgard Mazères, MD · Centre Leon Berard

Study Design

Allocation
NA
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01070537 on ClinicalTrials.gov