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Trial record 4 of 4 for:    9602574 [PUBMED-IDS]

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

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ClinicalTrials.gov Identifier: NCT01070537
Recruitment Status : Completed
First Posted : February 18, 2010
Last Update Posted : February 18, 2010
Sponsor:
Information provided by:
Centre Leon Berard

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.


Condition or disease Intervention/treatment Phase
Carcinoma Device: Bonfils fiberscope intubation Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
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
Study Start Date : February 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Leon Berard

Publications:

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 ( Registry Identifier: CENTRE LEON BERARD )
First Posted: February 18, 2010    Key Record Dates
Last Update Posted: February 18, 2010
Last Verified: February 2010

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