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

NCT ID: NCT00906932

Last Updated: 2009-05-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 159 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-03-31
• Study Completion Date: 2004-09-30

Brief Summary

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.

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.

Conditions

Healthy

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

See above

See above

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Males and females
• 18 years old and older

Exclusion Criteria

• Individuals less than 18
• Pregnant patients
• Inability to give consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Parker Medical

UNKNOWN

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

University of Texas Southwestern

Locations

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

References

Kim HJ, Chung SP, Park IC, Cho J, Lee HS, Park YS. Comparison of the GlideScope video laryngoscope and Macintosh laryngoscope in simulated tracheal intubation scenarios. Emerg Med J. 2008 May;25(5):279-82. doi: 10.1136/emj.2007.052803.

Reference Type: RESULT

PMID: 18434462 (View on PubMed)

Rowinsky EK, McGuire WP, Guarnieri T, Fisherman JS, Christian MC, Donehower RC. Cardiac disturbances during the administration of taxol. J Clin Oncol. 1991 Sep;9(9):1704-12. doi: 10.1200/JCO.1991.9.9.1704.

Reference Type: RESULT

PMID: 1678781 (View on PubMed)

Related Links

http://www.parkermedical.com

This is the manufacturer of the Trachview videoscope

Other Identifiers

IRB# 022004-040

Identifier Type: -

Identifier Source: org_study_id