NCT01070537

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 18, 2010

Completed
Last Updated

February 18, 2010

Status Verified

February 1, 2010

Enrollment Period

1.2 years

First QC Date

February 15, 2010

Last Update Submit

February 17, 2010

Conditions

Carcinoma

Keywords

OtolaryngologyEquipment and SuppliesIntubation

Outcome Measures

Primary Outcomes (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).

    180 sec after the beginning of the intubation

Secondary Outcomes (5)

  • 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

Interventions

Bonfils fiberscope intubationDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Léon Bérard

Lyon, 69373, France

Location

Related Publications (13)

  • 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.

    PMID: 1824555BACKGROUND

  • 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.

    PMID: 9602574BACKGROUND

  • 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.

    PMID: 8734245BACKGROUND

  • 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.

    PMID: 14616594BACKGROUND

  • 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.

    PMID: 15200542BACKGROUND

  • 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.

    PMID: 15549980BACKGROUND

  • 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.

    PMID: 6113794BACKGROUND

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

    PMID: 6507827BACKGROUND

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

    PMID: 7082756BACKGROUND

  • 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.

    PMID: 4835444BACKGROUND

  • 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.

    PMID: 4027773BACKGROUND

  • 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.

    PMID: 12512271BACKGROUND

  • 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.

    PMID: 21743336DERIVED

MeSH Terms

Conditions

Carcinoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Jean-Edgard Mazères, MD

    Centre Leon Berard

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 15, 2010

First Posted

February 18, 2010

Study Start

February 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

February 18, 2010

Record last verified: 2010-02

Locations

FR(1)