Clinical trial NCT01812915: Comparison of Tapered- vs. Cylindrical-shaped Tube Cuffs Pressure Alteration With Nitrous Oxide
Official title: Comparison of Tapered- vs. Cylindrical-shaped Tube Cuffs Pressure Alteration With Nitrous Oxide Diffusion Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adverse Effect of Other General Anesthetics
Anesthesia Intubation Complication
Inhalation of Nitrous Oxide
Trachea
Keywords: Cuff pressure
Cylindrical cuff
Endotracheal tube
Nitrous oxide
Tapered cuff
Lead sponsor: DongGuk University
Sponsor class: OTHER
First posted: 2013-03-18
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Intracuff pressure of the endotracheal tube after 60 min (1 hour) with exposure to nitrous oxide
timeFrame: One hour after the exposure to nitrous oxide under general anesthesia
Secondary outcomes:
measure: Intracuff pressure of the endotracheal tubes
timeFrame: 0, 10, 20, 30, 40, 50 minutes after exposure to nitrous oxide
measure: Postoperative sore throat: incidence
timeFrame: About 1, 6, 24 hours after termination of anesthesia
measure: Postoperative hoarseness: incidence
timeFrame: About 1, 6, 24 hours after termination of anesthesia
measure: Postoperative dysphagia: incidence
timeFrame: About 1, 6, 24 hours after termination of anesthesia
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: Dongguk University Ilsan Hospital
state: Gyeonggido
Study officials:
affiliation: DongGuk University
name: Junyong In, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.