NCT01975987

Brief Summary

This study is designed to identify patients' features predictive of successful intubation using the Bonfils fiberscope. Our hypothesis is that some patients' characteristics are predictors of successful intubation with the Bonfils fiberscope.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 5, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

July 18, 2014

Status Verified

July 1, 2014

Enrollment Period

6 months

First QC Date

October 22, 2013

Last Update Submit

July 17, 2014

Conditions

Keywords

IntubationBonfils fiberscope

Outcome Measures

Primary Outcomes (1)

  • Morphologic and morphometric predictors of successful tracheal intubation with the Bonfils fiberscope

    This study will correlate patients' morphometric and morphologic characteristics with the number of attempts and time needed for intubation using the Bonfils fiberscope.

    Patients will be followed from induction of anesthesia until the end of intubation, an average of 10 minutes

Secondary Outcomes (3)

  • Time to successful intubation

    Patients will be followed from induction of anesthesia until the end of intubation, an average of 10 minutes

  • Number of attempts to successful intubation

    Patients will be followed from induction of anesthesia until the end of intubation, an average of 10 minutes

  • Score on the Intubation Difficulty Scale

    Patients will be followed from induction of anesthesia until the end of intubation, an average of 10 minutes

Study Arms (1)

Intubation with the Bonfils fiberscope

EXPERIMENTAL

* Characteristics of patients will be assessed before induction of general anesthesia * Glottic visualization will be evaluated by direct laryngoscopy. * The endotracheal tube will be loaded onto the scope * Intubation will be performed with the Bonfils fiberscope with the patient in supine position with head and neck in neutral position * Bonfils fiberscope will be inserted from the right side of the patient's mouth, alongside the molars and advanced underneath the epiglottis. With the tip of the Bonfils in satisfactory position, the endotracheal tube will be advanced into the trachea using gentle rotary motions. The scope will then be removed. * Accurate positioning of the endotracheal tube will be confirmed by capnography and lung auscultation.

Device: Bonfils fiberscope

Interventions

Intubation with the Bonfils fiberscope

Eligibility Criteria

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

You may qualify if:

  • Age 18 and older
  • Patients undergoing elective surgery under general anesthesia, requiring endotracheal intubation

You may not qualify if:

  • Induction planned without neuromuscular blocking agents
  • Need for a rapid sequence induction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2L 4M1, Canada

Location

Study Officials

  • Arnaud Robitaille, MD, FRCPC

    Centre hospitalier de l'Université de Montréal (CHUM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2013

First Posted

November 5, 2013

Study Start

January 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

July 18, 2014

Record last verified: 2014-07

Locations