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NCT01812915 Clinical Trial

Comparison of Tapered- vs. Cylindrical-shaped Tube Cuffs Pressure Alteration With Nitrous Oxide

Anesthesia Intubation Complication Clinical Trial

Official title:
Comparison of Tapered- vs. Cylindrical-shaped Tube Cuffs Pressure Alteration With Nitrous Oxide Diffusion Under General Anesthesia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01812915
Other study ID # J In 2013-1
Secondary ID
Status Completed
Phase N/A
First received March 14, 2013
Last updated April 5, 2016
Start date January 2014
Est. completion date April 2015

Study information
Verified date April 2016
Source DongGuk University
Contact n/a
Is FDA regulated No
Health authority Korea: Ministry of Food and Drug SafetyKorea: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date April 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

Intervention

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.
• 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.

Locations
Country Name City State
Korea, Republic of Dongguk University Ilsan Hospital Goyang Gyeonggido

Sponsors (1)
Lead Sponsor Collaborator
DongGuk University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Intracuff pressure of the endotracheal tubes Intracuff pressures will be measured with a manometer (VBM, Sulz, Germany) 0, 10, 20, 30, 40, 50 minutes after exposure to nitrous oxide No
Secondary Postoperative sore throat: incidence About 1, 6, 24 hours after termination of anesthesia No
Secondary Postoperative hoarseness: incidence About 1, 6, 24 hours after termination of anesthesia No
Secondary Postoperative dysphagia: incidence About 1, 6, 24 hours after termination of anesthesia No
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