Adverse Effect of Other General Anesthetics, Anesthesia Intubation Complication, Inhalation of Nitrous Oxide, Trachea
Conditions
Keywords
Cuff pressure, Cylindrical cuff, Endotracheal tube, Nitrous oxide, Tapered cuff
Brief 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.
Interventions
DEVICECylindrical-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.
DEVICETapered-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.
Sponsors
DongGuk University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients who will undergo general anesthesia in a supine position with a neutral position of the head (hand and forearm sugery) * 18\ 70 years old * American society of anesthesiologists physical status 1-2 * Body mass index \< 30 kg/m2
Exclusion criteria
* Contraindication for nitrous oxide * Difficult intubation * Cormack-Lehane grade \> 3 * Airway-related or pulmonary diseases * Short or long operation time (\< 1 hour or \> 3 hours)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intracuff pressure of the endotracheal tube after 60 min (1 hour) with exposure to nitrous oxide | One hour after the exposure to nitrous oxide under general anesthesia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intracuff pressure of the endotracheal tubes | 0, 10, 20, 30, 40, 50 minutes after exposure to nitrous oxide | Intracuff pressures will be measured with a manometer (VBM, Sulz, Germany) |
| Postoperative sore throat: incidence | About 1, 6, 24 hours after termination of anesthesia | — |
| Postoperative hoarseness: incidence | About 1, 6, 24 hours after termination of anesthesia | — |
| Postoperative dysphagia: incidence | About 1, 6, 24 hours after termination of anesthesia | — |
Countries
South Korea
Outcome results
None listed