Trials / Completed
CompletedNCT01812915
Comparison of Tapered- vs. Cylindrical-shaped Tube Cuffs Pressure Alteration With Nitrous Oxide
Comparison of Tapered- vs. Cylindrical-shaped Tube Cuffs Pressure Alteration With Nitrous Oxide Diffusion Under General Anesthesia
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 38 (actual)
- Sponsor
- DongGuk University · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Adverse Effect of Other General Anesthetics
- Anesthesia Intubation Complication
- Inhalation of Nitrous Oxide
- Trachea
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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. |
| DEVICE | 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. |
Timeline
- Start date
- 2014-01-01
- Primary completion
- 2015-02-01
- Completion
- 2015-04-01
- First posted
- 2013-03-18
- Last updated
- 2016-04-07
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01812915. Inclusion in this directory is not an endorsement.