NCT01632683

Brief Summary

This study evaluates success rates of tracheal intubation (passing a breathing tube)for patients who may be more challenging to intubate while utilizing one of two devices that facilitate placement of the tube with video technology.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,100

participants targeted

Target at 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2012

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 3, 2012

Completed
10 months until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
2 months until next milestone

Results Posted

Study results publicly available

October 7, 2014

Completed
Last Updated

November 30, 2017

Status Verified

October 1, 2017

Enrollment Period

1.1 years

First QC Date

June 14, 2012

Results QC Date

September 30, 2014

Last Update Submit

October 25, 2017

Conditions

Keywords

difficult airwayvideo laryngoscopy

Outcome Measures

Primary Outcomes (1)

  • Intubation Success Rate

    Success rate is defined as a single blade insertion with successful tracheal tube placement confirmed by return of end-tidal carbon dioxide

    1 week

Secondary Outcomes (4)

  • Intubation Time

    1 week

  • Graded Score of Laryngeal View Achieved

    1 week

  • Number of Particpants Requiring Adjuncts to Assist Intubation

    1 week

  • Number of Participants With Observed Complications

    1 week

Study Arms (2)

C-MAC

ACTIVE COMPARATOR

Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation

Device: C-MAC

Glidescope

ACTIVE COMPARATOR

Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation

Device: Glidescope

Interventions

C-MACDEVICE

C-MAC arm

C-MAC

Glidescope arm

Glidescope

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult 18 years of age
  • Mallampati classification scale score of 3 or 4
  • Neck circumference greater than 40cm for males, 38 cm for females
  • mouth opening less than 3cm, but greater than 2cm

You may not qualify if:

  • children
  • prisoners
  • history of easy intubation (success on first attempt with direct laryngoscopy)
  • known unstable cervical spine injury
  • emergency surgery
  • nasal intubation route
  • planned awake technique

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

  • Aziz MF, Dillman D, Fu R, Brambrink AM. Comparative effectiveness of the C-MAC video laryngoscope versus direct laryngoscopy in the setting of the predicted difficult airway. Anesthesiology. 2012 Mar;116(3):629-36. doi: 10.1097/ALN.0b013e318246ea34.

    PMID: 22261795BACKGROUND

Results Point of Contact

Title
Michael Aziz, MD
Organization
Oregon Health & Science University

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 14, 2012

First Posted

July 3, 2012

Study Start

May 1, 2013

Primary Completion

June 1, 2014

Study Completion

August 1, 2014

Last Updated

November 30, 2017

Results First Posted

October 7, 2014

Record last verified: 2017-10

Locations