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

Carcinoma Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01070537
• Other study ID #: INVIBO
• Secondary ID: ET2007-036
• Status: Completed
• Phase: Phase 2
• First received: February 15, 2010
• Last updated: February 17, 2010
• Start date: February 2008
• Est. completion date: April 2009

Study information

• Verified date: February 2010
• Source: Centre Leon Berard
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment

Related Conditions & MeSH terms

• Carcinoma

Intervention

Device:
• Bonfils fiberscope intubation

Locations

Country	Name	City	State
France	Centre Léon Bérard	Lyon Cedex 08

Sponsors (1)

Lead Sponsor	Collaborator
Centre Leon Berard

Country where clinical trial is conducted

France, 

References & Publications (12)

Arné J, Descoins P, Fusciardi J, Ingrand P, Ferrier B, Boudigues D, Ariès 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. — View Citation

Bein B, Worthmann F, Scholz J, Brinkmann F, Tonner PH, Steinfath M, Dörges 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. — View Citation

Bein B, Yan M, Tonner PH, Scholz J, Steinfath M, Dörges V. Tracheal intubation using the Bonfils intubation fibrescope after failed direct laryngoscopy. Anaesthesia. 2004 Dec;59(12):1207-9. — View Citation

Benumof JL. Management of the difficult adult airway. With special emphasis on awake tracheal intubation. Anesthesiology. 1991 Dec;75(6):1087-110. Review. Erratum in: Anesthesiology 1993 Jan;78(1):224. — View Citation

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. French. — View Citation

Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11. — View Citation

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. — View Citation

Fleming TR. One-sample multiple testing procedure for phase II clinical trials. Biometrics. 1982 Mar;38(1):143-51. — View Citation

Halligan M, Charters P. A clinical evaluation of the Bonfils Intubation Fibrescope. Anaesthesia. 2003 Nov;58(11):1087-91. — View Citation

Loh KS, Irish JC. Traumatic complications of intubation and other airway management procedures. Anesthesiol Clin North America. 2002 Dec;20(4):953-69. Review. — View Citation

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. — View Citation

Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Number of well-tolerated BFI procedures		At the end of the intubation	Yes
Secondary	Duration of the intubation procedure among patients with a successful BFI (= 2 attempts and duration < 180 sec)		At the end of the intubation	No
Secondary	Frequency and type of difficulties met by the operator		At the end of the intubation	No
Secondary	Frequency and type of adverse events experienced by the patient		At the end of the intubation	Yes
Secondary	Patient's perception of the intubation procedure		In the recovery room and 7 days after the intubation	No