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NCT02949856 Clinical Trial

E-T Tube Cuff Pressure Change After Changing Position From Neutral to Hyperextension of Neck

Thyroidectomy Clinical Trial

Official title:
Endotracheal Tube Intracuff Pressure Change After Changing Position From Neutral to Hyperextension of Neck - Comparison of a Tapered Shaped- and Cylindrical Shaped Cuff

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02949856
Other study ID # 2016-05-032-001
Secondary ID
Status Not yet recruiting
Phase N/A
First received October 20, 2016
Last updated October 27, 2016
Start date October 2016
Est. completion date July 2017

Study information
Verified date October 2016
Source Keimyung University Dongsan Medical Center
Contact Yong-Cheol Lee, MD, PhD
Phone 82-53-250-7193
Email yclee@dsmc.or.kr
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This study evaluates difference of the endotracheal tube cuff pressure between a tapered- versus a cylindrical- shaped cuff after changing from neutral to hyperextension of neck.

Fifty patients undergoing thyroidectomy are randomly allocated into two groups (tapered- and cylindrical-shaped cuff). Endotracheal tube cuff pressure is initially set at 20 cmH20 in the supine neutral position and is measured after the change to the neck extension.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date July 2017
Est. primary completion date April 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- American Society of Anesthesiologists physical classification 1-3, 18-70 year old, thyroidectomy

Exclusion Criteria:

- difficult intubation, history of cervical disease, motion limitation of neck, morbid obesity

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Device:
• Mallinckrodt, COVIDIEN

• Endotracheal tube, Unomedica

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Keimyung University Dongsan Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary Change in intracuff pressure 1 year No
Secondary Change in distance from carina to tip of tube 1 year No
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