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The Effect of Esophageal Temperature Probe Insertion on Tracheal Cuff Pressure

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03375554
Collaborator
SMG-SNU Boramae Medical Center (Other)
112
Enrollment
1
Location
2.1
Actual Duration (Months)
54.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    112 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Effect of Esophageal Temperature Probe Insertion on Tracheal Cuff Pressure
    Actual Study Start Date :
    Apr 4, 2018
    Actual Primary Completion Date :
    Jun 5, 2018
    Actual Study Completion Date :
    Jun 6, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Change of cuff pressure [intraoperative]

      Change of cuff pressure by inserting of esophageal stethoscope, compared with before insertion of it

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul Metropolitan Government Seoul National University Boramae Medical Center Seoul Korea, Republic of 07061

    Sponsors and Collaborators

    • Seoul National University Hospital
    • SMG-SNU Boramae Medical Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jung-Man Lee, Clinical assistant professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT03375554
    Other Study ID Numbers:
    • 16-2017-78
    First Posted:
    Dec 18, 2017
    Last Update Posted:
    Aug 18, 2020
    Last Verified:
    Aug 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jung-Man Lee, Clinical assistant professor, Seoul National University Hospital
    esophageal steothoscope, tracheal intubation

    Study Results

    No Results Posted as of Aug 18, 2020