HealthyNCT00906932
Comparison Study of a New Fiberoptic Intubation Device to Standard Intubation Techniques
An observational study of Healthy, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Sep 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Medical students with no prior intubation experience and patients requiring intubation for elective surgery
Who may be able to join
- Males and females
- 18 years old and older
Who cannot join
- Individuals less than 18
- Pregnant patients
- Inability to give consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: A Prospective Study Comparing the Trachview Videoscope to Standard Direct Laryngoscopy for Orotracheal Intubation
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.
Read the 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
- Keywords
- Fiberoptic intubation, direct laryngoscopy, Trachview, Comparison of a fiberoptic intubating videoscope to direct laryngoscopy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startMar 2004
- Primary completionSep 2004
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Parker Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906932
- Sponsor's protocol ID
- IRB# 022004-040
- Status last verified
- May 2009
- First submitted
- 19 May 2009
- Last updated
- 21 May 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18434462Rowinsky 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.
PubMed 1678781
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Comparing the Trachview Videoscope to Standard Direct Laryngoscopy for Orotracheal Intubation
- ClinicalTrials.gov ID
- NCT00906932
- Acronym / sponsor ID
- IRB# 022004-040
- Conditions
- Healthy
- Keywords
- Fiberoptic intubation, direct laryngoscopy, Trachview, Comparison of a fiberoptic intubating videoscope to direct laryngoscopy.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Parker Medical
- Study start
- Mar 2004
- Primary completion
- Sep 2004 (actual)
- Study completion
- Sep 2004 (actual)
- First posted
- 21 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Medical students with no prior intubation experience and patients requiring intubation for elective surgery
Key inclusion criteria (2 listed)
- Males and females
- 18 years old and older
Key exclusion criteria (3 listed)
- Individuals less than 18
- Pregnant patients
- Inability to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2009.
- Results publication: PubMed 18434462Kim 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.
- Results publication: PubMed 1678781Rowinsky 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.
- This is the manufacturer of the Trachview videoscopeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00906932, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2009.