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

A Prospective Study Comparing the Trachview Videoscope to Standard Direct Laryngoscopy for Orotracheal Intubation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00906932
Enrollment
159
Registered
2009-05-21
Start date
2004-03-31
Completion date
2004-09-30
Last updated
2009-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Fiberoptic intubation, direct laryngoscopy, Trachview, Comparison of a fiberoptic intubating videoscope to direct laryngoscopy.

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.

Interventions

None listed

Sponsors

Parker Medical
CollaboratorUNKNOWN
University of Texas Southwestern Medical Center
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Males and females * 18 years old and older

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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).6 months

Secondary

MeasureTime frame
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.6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026