Comparison of the Cuff Pressure of a Taper-guard Cuffed Tube Between Ipsilateral and Contralateral Rotation of Head

May 14, 2018 updated by: Saeyoung Kim, MD, PhD, Kyungpook National University Hospital

Comparison of the Endotracheal Tube Cuff Pressure of a Taper-guard Cuffed Tube Between Ipsilateral and Contralateral Rotation of Head During Tympanoplasty; Prospective Study.

This study evaluates the endotracheal tube cuff pressure of a taper-guard cuffed tube during tympanoplasty with ipsilateral rotation of head, compared to the contralateral rotation of head.

The investigators will performed the ipsilateral rotation of head against the fixed tube in half of participants or the contralateral rotation of head in the other half.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The inflation of the endotracheal tube cuff is very useful to prevent aspiration of contaminated substances into lung past endotracheal tube and leakage of gas during positive pressure ventilation. However, excessive inflation of endotracheal tube cuff frequently causes tracheal mucosal damage, which can increase the incidence of sore throat, hoarseness, and coughing after surgery.

Taper-guard cuffed tube was newly developed. Taper-guard endotracheal tube is more effective in providing a sealing effect than a cylindrical endotracheal tube in an in vitro study. However, recently, it was reported that the cuff pressure of a Taper-guard endotracheal tube significantly increased after a positional change from the supine to the lateral flank position, compared to that of a cylindrical endotracheal tube. However, during tympanoplasty, the investigators need to rotate head for proper position.

In this study, therefore, the investigators investigate the difference of the endotracheal tube cuff pressure of a taper-guard cuffed tube between ipsilateral and contralateral rotation of head against the fixed tube during tympanoplasty.

Study Type

Interventional

Enrollment (Actual)

52

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 Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of, 700-412
        • Kyungpook National University Hospital

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:

  • American Society of Anesthesiologists physical status classification I-III for a tympanoplasty under general anesthesia

Exclusion Criteria:

  • history of difficult intubation, limited neck movement, respiratory diseases, and body mass index >35kg/m2

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: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ipsilateral rotation of head
Head was laterally rotated to the same side against fixed tube
Procedure: Ipsilateral rotation of head
Ipsilateral rotation of head against fixed tube
Active Comparator: Contralateral rotation of head
Head was laterally rotated to the opposite side against fixed tube
Procedure: Contralateral rotation of head
Contralateral rotation of head against fixed tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The endotracheal tube cuff pressure
Time Frame: During procedure
The endotracheal tube cuff pressure was checked using a manometer
During procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The distance from the endotracheal tube tip to the carina
Time Frame: During procedure
The distance from the endotracheal tube tip to the carina was recorded again using a fiberoptic bronchoscope.
During procedure

Collaborators and Investigators

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

Sponsor

Kyungpook National University Hospital

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 (Actual)

January 2, 2018

Primary Completion (Actual)

April 5, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

May 2, 2018

First Submitted That Met QC Criteria

May 2, 2018

First Posted (Actual)

May 15, 2018

Study Record Updates

Last Update Posted (Actual)

May 17, 2018

Last Update Submitted That Met QC Criteria

May 14, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 2017-12-001-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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