Comparison of Tapered- vs. Cylindrical-shaped Tube Cuffs Pressure Alteration With Nitrous Oxide
NCT ID: NCT01812915
Last Updated: 2016-04-07
Study Results
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Basic Information
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COMPLETED
NA
38 participants
INTERVENTIONAL
2014-01-31
2015-04-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TRIPLE
Study Groups
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Cylindrical-shape cuff ETT (Group C)
Control group: Mallinckrodt HiLo(TM) endotracheal tube. Intracuff pressures of the tubes every 10 minutes, Adult patients under general anesthesia with Mallinckrodt Hi-Lo(TM) tube.
Cylindrical-shape cuff ETT (Group C)
Randomized allocation of the endotracheal cuffs for general anesthesia, mechanical ventilation will be maintained with Mallinckrodt Hi-Lo(TM) endotracheal tube.
Tapered-shape cuff ETT (Group T)
Experimental group: Mallinckrodt TaperGuard(TM) endotracheal tube. Intracuff pressures of the tubes every 10 minutes, Adult patients under general anesthesia with Mallinckrodt TaperGuard(TM) tube.
Tapered-shape cuff ETT (Group T)
Randomized allocation of the endotracheal cuffs for general anesthesia, mechanical ventilation will be maintained with Mallinckrodt TaperGuard(TM) endotracheal tube.
Interventions
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Cylindrical-shape cuff ETT (Group C)
Randomized allocation of the endotracheal cuffs for general anesthesia, mechanical ventilation will be maintained with Mallinckrodt Hi-Lo(TM) endotracheal tube.
Tapered-shape cuff ETT (Group T)
Randomized allocation of the endotracheal cuffs for general anesthesia, mechanical ventilation will be maintained with Mallinckrodt TaperGuard(TM) endotracheal tube.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18\~70 years old
* American society of anesthesiologists physical status 1-2
* Body mass index \< 30 kg/m2
Exclusion Criteria
* Difficult intubation
* Cormack-Lehane grade \> 3
* Airway-related or pulmonary diseases
* Short or long operation time (\< 1 hour or \> 3 hours)
18 Years
70 Years
ALL
No
Sponsors
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DongGuk University
OTHER
Responsible Party
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Junyong In, MD
Associate Professor
Principal Investigators
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Junyong In, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
DongGuk University
Locations
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Dongguk University Ilsan Hospital
Goyang, Gyeonggido, South Korea
Countries
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References
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Tsuboi S, Miyashita T, Yamaguchi Y, Yamamoto Y, Sakamaki K, Goto T. The TaperGuard endotracheal tube intracuff pressure increase is less than that of the Hi-Lo tube during nitrous oxide exposure: a model trachea study. Anesth Analg. 2013 Mar;116(3):609-12. doi: 10.1213/ANE.0b013e318279b399. Epub 2013 Feb 11.
Other Identifiers
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J In 2013-1
Identifier Type: -
Identifier Source: org_study_id
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