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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02165319
Other study ID # LateralTaperedCuff-phpkhc
Secondary ID LateralCuff_SNUH
Status Not yet recruiting
Phase N/A
First received May 27, 2014
Last updated June 13, 2014
Start date July 2014
Est. completion date February 2015

Study information

Verified date June 2014
Source Seoul National University Hospital
Contact Hyun-Chang Kim, MD
Phone +821028862876
Email onidori1979@gmail.com
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

To compare the cuff pressure in lateral position between barrel-shaped cuff and taper-shaped cuff


Description:

The position of endotracheal tubes depends on the position of the patients. The change of the tube's position is known to influence the pressure of tube's cuff. The shape of the cuff (barrel-shaped versus tapered-shaped) may affect the tube's migration degree because of the difference of the frictional force.

The investigator try to compare the the cuff pressure after supine-to-lateral position change between barrel-shaped cuff and taper-shaped cuff.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 58
Est. completion date February 2015
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Patient scheduled for nephrectomy in lateral decubitus position

Exclusion Criteria:

- Pregnancy

- Patients with difficult airway

- Patients with neck motion disorder

- Patients with history of neck surgery

- Patients with history of oral and pharyngeal surgery

- Patients with body mass index > 35

- Patients without teeth

Study Design

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


Related Conditions & MeSH terms


Intervention

Device:
Barrel
Barrel-shaped endotracheal tube will be used during general anesthesia.
Tapered
Tapered-shaped tube will be used during general anesthesia.

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary The cuff pressure after supine-to-lateral position change The cuff pressure will be measured after supine-to-lateral position change using the Manometer Portex®. At 10 minutes after anesthetic induction Yes
Secondary The distance from the tube to the carina The distance from the tube to the carina will be measured using bronchoscopy after supine-to-lateral position change. At 10 minutes after anesthetic induction No
Secondary Complications related to endotracheal tube Complications related to endotracheal tube (sore throat, hoarseness, dysphagia and cough) will be measured as 0:none, 1:mild, 2:moderate, 3:severe at 0, 2, and 24 hours postoperatively. At 0, 2, and 24 hours postoperatively Yes
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