NCT01235065

Brief Summary

The purpose of this study is to assess if the GlideScope video laryngoscope is superior to the Macintosh direct laryngoscope for definitive airway management in acutely-injured patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
623

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2008

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2010

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 5, 2010

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2016

Completed
6.5 years until next milestone

Results Posted

Study results publicly available

June 1, 2023

Completed
Last Updated

June 1, 2023

Status Verified

June 1, 2018

Enrollment Period

8.4 years

First QC Date

October 22, 2010

Results QC Date

February 7, 2018

Last Update Submit

May 4, 2023

Conditions

Oral Intubation

Keywords

airway managementtraumaintubation

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Survived to Hospital Discharge

    Assessment of whether or not the patient was discharged alive from the study center

    2 weeks, on average

Secondary Outcomes (1)

  • Length of Time to Perform the Intubation Procedure

    Up to 100 seconds

Study Arms (2)

direct laryngoscope

ACTIVE COMPARATOR

emergency intubation with direct laryngoscopy technique

Device: type of laryngoscope

video laryngoscope

ACTIVE COMPARATOR

emergency intubation with video laryngoscopy technique

Device: type of laryngoscope

Interventions

type of laryngoscopeDEVICE

Patients who require emergency rapid sequence intubation are randomized to intubation with either the direct laryngoscope or the video laryngoscope

Also known as: Macintosh direct laryngoscope vs. GlideScope video laryngoscope
direct laryngoscopevideo laryngoscope

Eligibility Criteria

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

You may qualify if:

  • require emergency intubation

You may not qualify if:

  • age \< 18
  • require surgical airway on initial assessment
  • have known or strongly suspected spinal cord injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

R Adams Cowley Shock Trauma Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Results Point of Contact

Title
Dale Yeatts, Principal Investigator
Organization
R Adams Cowley Shock Trauma Center
djyeatts@gmail.com
443-909-0648

Study Officials

  • Dale Yeatts, MD

    University of Maryland

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

October 22, 2010

First Posted

November 5, 2010

Study Start

July 1, 2008

Primary Completion

November 16, 2016

Study Completion

November 16, 2016

Last Updated

June 1, 2023

Results First Posted

June 1, 2023

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

None exists

Locations

US(1)