NCT00178555

Brief Summary

The purpose of this study is to determine if the Video Laryngoscope (VL) is a useful instrument in patients at risk for difficult intubation. We will compare this device to the traditional Macintosh Laryngoscope.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2003

Longer than P75 for phase_4

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

August 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

March 23, 2016

Status Verified

March 1, 2016

Enrollment Period

3.5 years

First QC Date

September 12, 2005

Last Update Submit

March 22, 2016

Conditions

Intubation, Endotracheal

Keywords

Endotracheal Intubation, Video Laryngoscopy

Outcome Measures

Primary Outcomes (1)

  • 5 scale score of glottic view; Time and number of attempts required; Level of difficulty; Degree of irritation of the pharynx, epiglottis, and aryteniods

Secondary Outcomes (1)

  • Vital signs, oxygen saturation, and end-tidal carbon dioxide

Interventions

DCI Video Intubation System-Macintosh LaryngoscopeDEVICE
Macintosh LaryngoscopeDEVICE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-80
  • ASA I-III
  • Presenting for elective surgery
  • Requires general anesthesia
  • Present as a possible difficult intubation (one or more of the following)
  • history of difficult intubations
  • morbid obesity
  • small mouth opening (\<3 fingerbreadths)
  • limited neck mobility
  • Mallampati classes II-III
  • short thyromental distance (\<6 cm)

You may not qualify if:

  • Determined to be easily intubated (none of the factors listed above)
  • Considered so difficult (i.e. Mallampati IV) that an awake intubation should be performed
  • ASA IV and V

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

Study Officials

  • Carin A. Hagberg, M.D.

    The University of Texas Medical School at Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chairman, Joseph C. Gable, M.D., Endowed Chair

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

August 1, 2003

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

March 23, 2016

Record last verified: 2016-03

Locations

US(1)