Comparison Study of a New Fiberoptic Intubation Device to Standard Intubation Techniques

This study has been completed.
Sponsor:
Collaborator:
Parker Medical
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00906932
First received: May 19, 2009
Last updated: May 20, 2009
Last verified: May 2009
  Purpose

This is a two part study comparing the Trachview videoscope to standard laryngoscopy in their ability to visualize the glottic opening. It is hypothesized that the glottic view is improved with the Trachview videoscope. Not only can the Trachview provide an alternative and often improved view of the airway, but can be used for teaching novice intubators. Furthermore, the Trachview requires minimal deviation from standard intubating techniques and thus, it is much easier to learn and use than many fiberoptic scopes currently available.


Condition
Healthy

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Prospective Study Comparing the Trachview Videoscope to Standard Direct Laryngoscopy for Orotracheal Intubation

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • In part one, the median POGO score for direct laryngoscopy was 25% and 90% for the TrachView™ (p<0.001). In part two, the POGO score for direct laryngoscopy was 100% in only 67 of the 122 cases while, for TrachView™ it was 100% in 109 (p<0.001). [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • In part one, the TrachView™ was "easy" to use by 68% of the trainees. In part two, the clinicians also reported that the TrachView™ was "easy" to use. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 159
Study Start Date: March 2004
Study Completion Date: September 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Groups/Cohorts
Trachview videoscope, direct laryngoscopy
Each subject served as their own control - the Trachview videoscope and direct laryngoscopy was performed on by all subjects in a sequential fashion.
See above
See above

Detailed Description:

This is a two part study. Part one: Adult airway mannequins were used. Subjects were medical students with no previous experience in intubation.

Part two: This was a convenience sample of patients undergoing elective surgery. All patients were consented. The subjects were physicians and nurse anesthetists who were going to be intubated in the operating room setting.

For both parts of the study, the subjects viewed the glottic opening using direct laryngoscopy followed or preceded by visualization of the glottic opening using the Trachview. The subjects were asked to score the amount of the glottic opening that could be visualized using the POGO (percent of glottic opening)score. Subjects were only given a very brief inservice on how to use the Trachview. Additional measurements such as presurgical airway assessments of the patients were obtained.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Medical students with no prior intubation experience and patients requiring intubation for elective surgery

Criteria

Inclusion Criteria:

  • Males and females
  • 18 years old and older

Exclusion Criteria:

  • Individuals less than 18
  • Pregnant patients
  • Inability to give consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00906932

Locations
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Parker Medical
  More Information

Additional Information:
Publications:
Responsible Party: Lynn P. Roppolo, Assistant Professor, University of Texas Southwestern
ClinicalTrials.gov Identifier: NCT00906932     History of Changes
Other Study ID Numbers: IRB# 022004-040
Study First Received: May 19, 2009
Last Updated: May 20, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Fiberoptic intubation
direct laryngoscopy
Trachview
Comparison of a fiberoptic intubating videoscope to direct laryngoscopy.

ClinicalTrials.gov processed this record on September 18, 2014