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

Léon Bérard Center

Status and phase: Completed; Phase 2

Conditions: Carcinoma

Treatments: Device: Bonfils fiberscope intubation

Study type: Interventional

Funder types: Other

Identifiers

NCT01070537

ET2007-036 (Registry Identifier)

INVIBO

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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