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

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.

Study Overview

• Status: Completed
• Conditions: Carcinoma
• Intervention / Treatment: Device: Bonfils fiberscope intubation

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Lyon Cedex 08, France, 69373
    • Centre Léon Bérard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Leon Berard
• Investigators: Principal Investigator: Jean-Edgard Mazères, MD, Centre Léon Bérard

Publications and helpful links

General Publications

• 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.
• 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.
• Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11.
• 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.
• Fleming TR. One-sample multiple testing procedure for phase II clinical trials. Biometrics. 1982 Mar;38(1):143-51.
• 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. Erratum In: Anesthesiology 1993 Jan;78(1):224.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: February 15, 2010
• First Submitted That Met QC Criteria: February 17, 2010
• First Posted (Estimate): February 18, 2010

Study Record Updates

• Last Update Posted (Estimate): February 18, 2010
• Last Update Submitted That Met QC Criteria: February 17, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: Intubation; Otolaryngology; Equipment and Supplies
• Other Study ID Numbers: INVIBO; ET2007-036 (Registry Identifier: CENTRE LEON BERARD)