Clinical trial NCT01070537: Evaluation of the Bonfils Fiberscope for Predicted Difficult Intubation in Awake Patients With Ear, Nose, and Throat (ENT) Cancer (INVIBO)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma
Keywords: Otolaryngology
Equipment and Supplies
Intubation
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2010-02-18
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: 180 sec after the beginning of the intubation
Secondary outcomes:
measure: Number of well-tolerated BFI procedures
timeFrame: At the end of the intubation
measure: Duration of the intubation procedure among patients with a successful BFI (≤ 2 attempts and duration < 180 sec)
timeFrame: At the end of the intubation
measure: Frequency and type of difficulties met by the operator
timeFrame: At the end of the intubation
measure: Frequency and type of adverse events experienced by the patient
timeFrame: At the end of the intubation
measure: Patient's perception of the intubation procedure
timeFrame: In the recovery room and 7 days after the intubation
Other outcomes:
Locations:
city: Lyon Cedex 08
country: France
facility: Centre Léon Bérard
Study officials:
affiliation: Centre Leon Berard
name: Jean-Edgard Mazères, MD
role: PRINCIPAL_INVESTIGATOR
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