NCT01865643

Brief Summary

The aim of this study is to compare the hemodynamic response to tracheal intubations using the standard technique versus the alternative GS intubation technique. As secondary outcomes the investigators will analyze procedure time, success rate and injury rate. The investigators hypothesize that the alternative intubation technique will have a shorter procedure time and lower injury rate when compared to the standard technique of GS intubation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2013

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

Study Start

First participant enrolled

May 1, 2013

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 31, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

August 21, 2014

Status Verified

August 1, 2014

Enrollment Period

1 year

First QC Date

May 28, 2013

Last Update Submit

August 19, 2014

Conditions

Keywords

LaryngoscopyIntubationGlidescope

Outcome Measures

Primary Outcomes (1)

  • Hemodynamic response to tracheal intubation

    Heart rate and non-invasive blood pressure will be measured before induction, and throughout and after laryngoscopy and induction

    24 hours

Secondary Outcomes (3)

  • Procedure time

    10 minutes

  • Success rate

    10 minutes

  • Injury rate

    30 minutes

Study Arms (2)

Standard GlideScope intubation

OTHER

This standard GlideScope (GS) technique involves a midline larygoscopy followed by insertion of a styleted endotracheal tube, once an adequate view of the vocal cords is achieved.

Device: GlideScope

Alternative GlideScope intubation

EXPERIMENTAL

Alternative GlideScope (GS) intubation involves the insertion of the endotracheal tube under direct vision as a "fish hook" at the side of the mouth before the GS blade is introduced into the oropharynx.

Device: GlideScope

Interventions

The GlideScope is used to assist with difficult tracheal intubation.

Alternative GlideScope intubationStandard GlideScope intubation

Eligibility Criteria

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

You may qualify if:

  • Patients of ASA physical status 1-2
  • Patients aged 18 years and older
  • Patients undergoing elective surgery that requires tracheal intubation

You may not qualify if:

  • Patients in whom a rapid sequence intubation or alternative intubation method is indicated
  • Patients with a known or suspected oral, pharyngeal or laryngeal mass
  • Patients previously flagged as a difficult intubation
  • Patients with hypertension (treated or untreated, poor dentition, symptomatic gastro-esophageal reflux or cervical spine instability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

Study Officials

  • Zeev Friedman, MD

    MOUNT SINAI HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2013

First Posted

May 31, 2013

Study Start

May 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

August 21, 2014

Record last verified: 2014-08

Locations