Comparison Study of a New Fiberoptic Intubation Device to Standard Intubation Techniques
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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 |
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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 |
- 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 ]
- 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 |
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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.
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See above
See above
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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 |
Medical students with no prior intubation experience and patients requiring intubation for elective surgery
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 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:
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Fiberoptic intubation direct laryngoscopy Trachview Comparison of a fiberoptic intubating videoscope to direct laryngoscopy. |
ClinicalTrials.gov processed this record on June 18, 2013