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Completed

NCT Number: NCT01070537

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

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.

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Key information

Conditions

Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Léon Bérard

Lyon, 69373, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bonfils fiberscope intubation

Device

Primary outcomes

  1. 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).

    Time frame: 180 sec after the beginning of the intubation

Secondary outcomes

  1. Number of well-tolerated BFI procedures

    Time frame: At the end of the intubation

  2. Duration of the intubation procedure among patients with a successful BFI (≤ 2 attempts and duration < 180 sec)

    Time frame: At the end of the intubation

  3. Frequency and type of difficulties met by the operator

    Time frame: At the end of the intubation

  4. Frequency and type of adverse events experienced by the patient

    Time frame: At the end of the intubation

  5. Patient's perception of the intubation procedure

    Time frame: In the recovery room and 7 days after the intubation

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Registry information

Official study title

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

Acronym: INVIBO

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 18, 2010
Registry last updated
Feb 18, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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