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Comparison of Tapered- vs. Cylindrical-shaped Tube Cuffs Pressure Alteration With Nitrous Oxide Diffusion Under General Anesthesia
When using nitrous oxide for general anesthesia, nitrous oxide diffusion induces intracuff hyperinflation of the endotracheal tube. Furthermore the difference among various types of cuffed endotracheal tubes in cuff pressure behavior during nitrous oxide exposure. TaperGuard(TM) tube has been newly introduced and has tapered-shape cuff. In vitro study, the intracuff pressure of TaperGuard(TM) tube was lower than that of conventional tube with cylindrical-shaped cuff of the conventional tube(Hi-Lo(TM) tube). Therefore, this clinical study is needed to evaluate the intracuff pressure during general anesthesia with nitrous oxide exposure.
During 60 minutes after routine anesthetic induction and intubation of the endotracheal tubes, intracuff pressures will be measured every 10 minutes with a manometer (VBM, Sulz, Germany). 60% nitrous oxide will be added at time 0. For 60 minutes from the beginning of general anesthesia, intracuff pressures will be measured every 10 minutes. After 60 minutes, Intracuff pressures will be maintained around 20 cm H2O during the remaining period of the surgery. The questionnaire for a sore throat, hoarseness, and dysphagia will be questioned at about 1, 6, and 24 hours after the surgery and the general anesthesia.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Dongguk University Ilsan Hospital
Goyang, Gyeonggido, South Korea
Start Date
January 1, 2014
Primary Completion Date
February 1, 2015
Completion Date
April 1, 2015
Last Updated
April 7, 2016
38
ACTUAL participants
Cylindrical-shape cuff ETT (Group C)
DEVICE
Tapered-shape cuff ETT (Group T)
DEVICE
Lead Sponsor
DongGuk University
NCT06091631
NCT05941767
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View ClinicalTrials.gov Terms and ConditionsNCT03902704