NCT02769819

Brief Summary

This study is designed to identify patients' features predictive of difficult endotracheal intubation using a flexible fiberscope.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
420

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

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

First Submitted

Initial submission to the registry

May 10, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2017

Completed
Last Updated

October 9, 2017

Status Verified

October 1, 2017

Enrollment Period

12 months

First QC Date

May 10, 2016

Last Update Submit

October 6, 2017

Conditions

Keywords

Flexible fiberscope

Outcome Measures

Primary Outcomes (1)

  • Morphologic and morphometric predictors of difficult intubation with the flexible fiberscope.

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

EXPERIMENTAL

Following induction of general anesthesia and administration of a neuromuscular blocking agent, intubation will be performed using a flexible fiberscope.

Device: Flexible fiberscope

Interventions

* 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 after silicon spray lubrication * Intubation will be performed with the flexible fiberscope with the patient in supine position with head and neck in neutral position * With the tip of the fiberscope in satisfactory position, the endotracheal tube will be advanced into the trachea. The scope will then be removed. * Accurate positioning of the endotracheal tube will be confirmed by capnography and lung auscultation.

Intubation with a flexible 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

Related Publications (1)

  • Toure T, Williams SR, Kerouch M, Ruel M. Patient factors associated with difficult flexible bronchoscopic intubation under general anesthesia: a prospective observational study. Can J Anaesth. 2020 Jun;67(6):706-714. doi: 10.1007/s12630-020-01568-w. Epub 2020 Jan 17.

Study Officials

  • Stephan R Williams, MD, PhD

    Centre hospitalier de l'Université de Montréal (CHUM)

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 10, 2016

First Posted

May 12, 2016

Study Start

October 1, 2016

Primary Completion

September 12, 2017

Study Completion

September 12, 2017

Last Updated

October 9, 2017

Record last verified: 2017-10

Locations