Evaluation of the Bonfils Fiberscope for Predicted Difficult Intubation in Awake Patients With Ear, Nose, and Throat (ENT) Cancer (INVIBO)
NCT ID: NCT01070537
Last Updated: 2010-02-18
Study Results
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Basic Information
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COMPLETED
PHASE2
41 participants
INTERVENTIONAL
2008-02-29
2009-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
Interventions
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Bonfils fiberscope intubation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Centre Leon Berard
OTHER
Responsible Party
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Centre Léon Bérard - 28 rue Laennec - 69373 LYON Cedex 08 - France
Principal Investigators
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Jean-Edgard Mazères, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Leon Berard
Locations
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Centre Léon Bérard
Lyon, , France
Countries
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References
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Benumof JL. Management of the difficult adult airway. With special emphasis on awake tracheal intubation. Anesthesiology. 1991 Dec;75(6):1087-110. doi: 10.1097/00000542-199112000-00021.
Arne J, Descoins P, Fusciardi J, Ingrand P, Ferrier B, Boudigues D, Aries J. Preoperative assessment for difficult intubation in general and ENT surgery: predictive value of a clinical multivariate risk index. Br J Anaesth. 1998 Feb;80(2):140-6. doi: 10.1093/bja/80.2.140.
Boisson-Bertrand D, Bourgain JL, Camboulives J, Crinquette V, Cros AM, Dubreuil M, Eurin B, Haberer JP, Pottecher T, Thorin D, Ravussin P, Riou B. [Difficult intubation. French Society of Anesthesia and Intensive Care. A collective expertise]. Ann Fr Anesth Reanim. 1996;15(2):207-14. No abstract available. French.
Halligan M, Charters P. A clinical evaluation of the Bonfils Intubation Fibrescope. Anaesthesia. 2003 Nov;58(11):1087-91. doi: 10.1046/j.1365-2044.2003.03407.x.
Bein B, Worthmann F, Scholz J, Brinkmann F, Tonner PH, Steinfath M, Dorges V. A comparison of the intubating laryngeal mask airway and the Bonfils intubation fibrescope in patients with predicted difficult airways. Anaesthesia. 2004 Jul;59(7):668-74. doi: 10.1111/j.1365-2044.2004.03778.x.
Bein B, Yan M, Tonner PH, Scholz J, Steinfath M, Dorges V. Tracheal intubation using the Bonfils intubation fibrescope after failed direct laryngoscopy. Anaesthesia. 2004 Dec;59(12):1207-9. doi: 10.1111/j.1365-2044.2004.03967.x.
Fahey MR, Morris RB, Miller RD, Sohn YJ, Cronnelly R, Gencarelli P. Clinical pharmacology of ORG NC45 (NorcuronTM): a new nondepolarizing muscle relaxant. Anesthesiology. 1981 Jul;55(1):6-11. doi: 10.1097/00000542-198107000-00003.
Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11.
Fleming TR. One-sample multiple testing procedure for phase II clinical trials. Biometrics. 1982 Mar;38(1):143-51.
Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. doi: 10.1136/bmj.2.5920.656.
Mallampati SR, Gatt SP, Gugino LD, Desai SP, Waraksa B, Freiberger D, Liu PL. A clinical sign to predict difficult tracheal intubation: a prospective study. Can Anaesth Soc J. 1985 Jul;32(4):429-34. doi: 10.1007/BF03011357.
Loh KS, Irish JC. Traumatic complications of intubation and other airway management procedures. Anesthesiol Clin North Am. 2002 Dec;20(4):953-69. doi: 10.1016/s0889-8537(02)00022-6.
Mazeres JE, Lefranc A, Cropet C, Steghens A, Bachmann P, Perol O, Rosay H. Evaluation of the Bonfils intubating fibrescope for predicted difficult intubation in awake patients with ear, nose and throat cancer. Eur J Anaesthesiol. 2011 Sep;28(9):646-50. doi: 10.1097/EJA.0b013e3283495b85.
Other Identifiers
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ET2007-036
Identifier Type: REGISTRY
Identifier Source: secondary_id
INVIBO
Identifier Type: -
Identifier Source: org_study_id
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