The Effect of Esophageal Temperature Probe Insertion on Tracheal Cuff Pressure

August 14, 2020 updated by: Jung-Man Lee, Seoul National University Hospital
The goal of this prospective observational study is to investigate the effect on esophageal stethoscope insertion on tracheal cuff pressure during general anesthesia.

Study Overview

Status

Completed

Conditions

Detailed Description

It is well known that cuff pressure of tracheal tube should not be over 30 cmH2O. Therefore, anesthesiologists usually pay attention to maintain adequate cuff pressure, especially just after completion of tracheal intubation. Recently, esophageal stethoscope is widely used for exact monitoring of patient's body temperature. However, inserting of foreign body in esophagus could affect on the cuff pressure.

The goal of this prospective observational study is to investigate the effect on esophageal stethoscope insertion on tracheal cuff pressure.

Study Type

Observational

Enrollment (Actual)

112

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
      • Seoul, Korea, Republic of, 07061
        • Seoul Metropolitan Government Seoul National University Boramae Medical Center

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient receiving general anesthesia for elective surgery

Description

Inclusion Criteria:

  • Patient receiving general anesthesia for elective surgery

Exclusion Criteria:

  • who doesn't agree to enroll
  • who has any clinical disease or history of surgery in esophagus
  • who has aspiration tendency

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of cuff pressure
Time Frame: intraoperative
Change of cuff pressure by inserting of esophageal stethoscope, compared with before insertion of it
intraoperative

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Collaborators

SMG-SNU Boramae Medical Center

Investigators

  • Principal Investigator: Jung-Man Lee, M.D.,PhD, SMG-SNU Boramae Medical Center

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)

April 4, 2018

Primary Completion (Actual)

June 5, 2018

Study Completion (Actual)

June 6, 2018

Study Registration Dates

First Submitted

December 13, 2017

First Submitted That Met QC Criteria

December 13, 2017

First Posted (Actual)

December 18, 2017

Study Record Updates

Last Update Posted (Actual)

August 18, 2020

Last Update Submitted That Met QC Criteria

August 14, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 16-2017-78

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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