- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00906932
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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Texas
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Dallas, Texas, Förenta staterna, 75390
- University of Texas Southwestern Medical Center
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Males and females
- 18 years old and older
Exclusion Criteria:
- Individuals less than 18
- Pregnant patients
- Inability to give consent
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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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
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
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).
Tidsram: 6 months
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6 months
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Sekundära resultatmått
Resultatmått |
Tidsram |
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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.
Tidsram: 6 months
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6 months
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Samarbetspartners och utredare
Samarbetspartners
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- IRB# 022004-040
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