Transesophageal Echocardiography(TEE) Probe Insertion and Tracheal Cuff Pressure (TEE)

September 15, 2014 updated by: Seoul National University Hospital

Increase of Tracheal Cuff Pressure During Transesophageal Echocardiography Probe Insertion: Double-lumen Tube Versus Single-lumen Tube

Tracheal cuff overinflation is known to reduce tracheal mucosal blood flow and to increase tracheal morbidity. Transesophageal echocardiography (TEE) probe insertion may increase the tracheal cuff pressure. The aim of this study is to evaluate the effect of TEE probe insertion on tracheal cuff pressure and to compare the effects in single-lumen tube and double-lumen tube.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

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

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:

  • adult patients scheduled for elective cardiothoracic surgery
  • requiring intraoperative TEE monitoring

Exclusion Criteria:

  • patients with tracheal stenosis
  • patients with tracheoesophageal fistula
  • patients with esophageal surgery
  • patients with esophageal varix
  • patients with Barrett esophagus
  • patients with esophageal hernia
  • patients with descending thoracic aorta aneurysm
  • patients with dysphagia
  • patients with vocal fold palsy

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: patients with single-lumen tube
Patients who required intraoperative TEE and single-lumen tube; balloon pressure adjustment before TEE probe insertion
Procedure: balloon pressure adjustment
Tracheal cuff pressure was adjusted to 18 mmHg (25 cmH2O) before TEE probe insertion
Other: patients with double-lumen tube
Patients who required intraoperative TEE and double-lumen tube; balloon pressure adjustment before TEE probe insertion
Procedure: balloon pressure adjustment
Tracheal cuff pressure was adjusted to 18 mmHg (25 cmH2O) before TEE probe insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tracheal cuff pressure
Time Frame: 1 min after TEE probe insertion
1 min after TEE probe insertion

Secondary Outcome Measures

Outcome Measure
Time Frame
Tracheal cuff pressure
Time Frame: every min for 5 min after TEE probe insertion
every min for 5 min after TEE probe insertion

Collaborators and Investigators

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

Sponsor

Seoul National University 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

October 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

January 9, 2014

First Submitted That Met QC Criteria

January 10, 2014

First Posted (Estimate)

January 13, 2014

Study Record Updates

Last Update Posted (Estimate)

September 17, 2014

Last Update Submitted That Met QC Criteria

September 15, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • YSJeon_Cuff

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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