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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01070537

Acronym

INVIBO

Enrollment

Registered

2010-02-18

Start date

2008-02-29

Completion date

2009-04-30

Last updated

2010-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma

Keywords

Otolaryngology, Equipment and Supplies, Intubation

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.

Interventions

DEVICEBonfils fiberscope intubation

Study design

Allocation

Intervention model

SINGLE_GROUP

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Patient's perception of the intubation procedure	In the recovery room and 7 days after 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
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026