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

This study has been completed.
Sponsor:
Information provided by:
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT01070537
First received: February 15, 2010
Last updated: February 17, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Carcinoma
Device: Bonfils fiberscope intubation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
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

Further study details as provided by Centre Leon Berard:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of well-tolerated BFI procedures [ Time Frame: At the end of the intubation ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Frequency and type of difficulties met by the operator [ Time Frame: At the end of the intubation ] [ Designated as safety issue: No ]
  • Frequency and type of adverse events experienced by the patient [ Time Frame: At the end of the intubation ] [ Designated as safety issue: Yes ]
  • Patient's perception of the intubation procedure [ Time Frame: In the recovery room and 7 days after the intubation ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: February 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01070537

Locations
France
Centre Léon Bérard
Lyon Cedex 08, France, 69373
Sponsors and Collaborators
Centre Leon Berard
Investigators
Principal Investigator: Jean-Edgard Mazères, MD Centre Léon Bérard
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jean-Edgard MAZERES, Centre Léon Bérard - 28 rue Laennec - 69373 LYON Cedex 08 - France
ClinicalTrials.gov Identifier: NCT01070537     History of Changes
Other Study ID Numbers: INVIBO, ET2007-036
Study First Received: February 15, 2010
Last Updated: February 17, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Leon Berard:
Otolaryngology
Equipment and Supplies
Intubation

ClinicalTrials.gov processed this record on November 24, 2014