The Cuff Pressure of an Endotracheal Tube After Supine-to-lateral Position Change (LateralCuff)

June 13, 2014 updated by: Hee-Pyoung Park, Seoul National University Hospital

Comparison of the Cuff Pressure of an Endotracheal Tube After Supine-to-lateral Position Change: Barrel-shaped vs. Taper-shaped Cuff

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
        • Principal Investigator:
          • Hyun-Chang Kim, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Barrel
Endotracheal tube with barrel-shaped cuff will be used during general anesthesia.
Device: Barrel
Barrel-shaped endotracheal tube will be used during general anesthesia.
Active Comparator: Tapered
Endotracheal tube with tapered-shaped cuff will be used during general anesthesia.
Device: Tapered
Tapered-shaped tube will be used during general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The cuff pressure after supine-to-lateral position change
Time Frame: At 10 minutes after anesthetic induction
The cuff pressure will be measured after supine-to-lateral position change using the Manometer Portex®.
At 10 minutes after anesthetic induction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The distance from the tube to the carina
Time Frame: At 10 minutes after anesthetic induction
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
Complications related to endotracheal tube
Time Frame: At 0, 2, and 24 hours postoperatively
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Hee-Pyoung Park, PhD, Seoul National University of Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

February 1, 2015

Study Registration Dates

First Submitted

May 27, 2014

First Submitted That Met QC Criteria

June 13, 2014

First Posted (Estimate)

June 17, 2014

Study Record Updates

Last Update Posted (Estimate)

June 17, 2014

Last Update Submitted That Met QC Criteria

June 13, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LateralTaperedCuff-phpkhc
  • LateralCuff_SNUH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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