NCT00956592

Brief Summary

This study aims to evaluate the utility of a video assisted device for intubation (placement of a breathing tube) during surgery. This study specifically aims to compare a video assisted intubation with the CMAC laryngoscope to conventional devices in the setting of intubations predicted to be difficult.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2009

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

August 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 11, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
3 months until next milestone

Results Posted

Study results publicly available

March 9, 2011

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

1.2 years

First QC Date

August 10, 2009

Results QC Date

January 25, 2011

Last Update Submit

April 3, 2018

Conditions

IntubationAirway Management

Keywords

Video laryngoscopyIntubation successDifficult airwayCMAC laryngoscope

Outcome Measures

Primary Outcomes (1)

  • Measure of Intubation Success

    Success was measured by confirmed tracheal tube placement with one attempt. Any removal of the laryngoscope blade constituted a failure

    During each intubation in a 14 month period

Secondary Outcomes (5)

  • Intubation Time

    During laryngoscopy procedure

  • Number of Participants Intubated With a Rescue Device

    1 year

  • Number of Participants With Complications

    1 year

  • Number of Participants With a Laryngeal View Grade of 1 or 2 vs. 3 or 4.

    1 year

  • Number of Particpants Requiring Adjuncts to Assist Intubation

    1 year

Study Arms (2)

CMAC Video laryngoscope

ACTIVE COMPARATOR

Subjects will have their intubation attempted first with the CMAC video laryngoscope

Device: CMAC video laryngoscope

Macintosh blade

ACTIVE COMPARATOR

Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade

Device: Macintosh laryngoscope

Interventions

CMAC video laryngoscopeDEVICE

Intubation utilizing the assistance of video enhancement

Also known as: CMAC, Storz laryngoscope
CMAC Video laryngoscope
Macintosh laryngoscopeDEVICE

Patients will be intubated utilizing either a Macintosh 3 or Macintosh 4 designed blade

Also known as: Mac blade
Macintosh blade

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients presenting for elective surgery who are fasted and who have one of the following difficult airway predictors:
  • mallampati classification 3
  • mallampati classification 4
  • Reduced mouth opening (\<3cm)
  • reduced cervical motion
  • history of previous difficult intubation or multiple laryngoscopy attempts

You may not qualify if:

  • Patients less than 18 years old, patients who are not fasted (\>6 hrs. NPO)
  • Patients who have contraindications to the administration of neuromuscular blocking drugs
  • Patients who have a documented history of intubation on first attempt with C-L grade 1 laryngeal view
  • Patients who are deemed to difficult and dangerous to anesthetize without first securing an airway.

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)

  • Jungbauer A, Schumann M, Brunkhorst V, Borgers A, Groeben H. Expected difficult tracheal intubation: a prospective comparison of direct laryngoscopy and video laryngoscopy in 200 patients. Br J Anaesth. 2009 Apr;102(4):546-50. doi: 10.1093/bja/aep013. Epub 2009 Feb 20.

    PMID: 19233881BACKGROUND

Results Point of Contact

Title
Michael Aziz
Organization
Oregon Health & Science University
azizm@ohsu.edu
503-494-5581

Study Officials

  • Michael Aziz, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Department of Anesthesiology & Perioperative Medicine

Study Record Dates

First Submitted

August 10, 2009

First Posted

August 11, 2009

Study Start

October 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

April 5, 2018

Results First Posted

March 9, 2011

Record last verified: 2018-04

Locations

US(1)