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Feasibility and Accuracy of Core Temperature Measurements Using the Esophageal Temperature Probe Inserted Through the Gastric Lumen of Supraglottic Airway Device in Pediatrics

Sponsor
Asan Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT05705206
Collaborator
(none)
41
Enrollment
1
Location
11.7
Actual Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In pediatric patients, the accuracy of body temperature measured with an esophageal temperature probe placed through the gastric lumen of the supraglottic airway device is investigated.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Pediatric patients using a supraglottic airway device during general anesthesia are targeted. When the patient enters the operating room, standard monitoring is performed, general anesthesia is induced, a supraglottic airway device is installed, and an anesthesiologist inserts an esophageal thermometer through the gastric lumen. We recorded the body temperature measured in the esophagus, tympanic membrane, temporal artery, and rectum every 10 minutes from 10 minutes after insertion.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    41 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Feasibility and Accuracy of Core Temperature Measurements Using the Esophageal Temperature Probe Inserted Through the Gastric Lumen of Supraglottic Airway Device in Pediatrics: a Prospective Observational Study
    Actual Study Start Date :
    Mar 25, 2021
    Actual Primary Completion Date :
    Mar 16, 2022
    Actual Study Completion Date :
    Mar 16, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Comparison of esophageal temperature and temperature at tympanic membrane, rectum, temporal artery [10min]

      'c

    Secondary Outcome Measures

    1. Effect of gastric suction through an esophageal temperature probe [After inserting the esophageal temperature probe]

      Evaluated via gastric sonography

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 6 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Pediatrics patients under six years old with ASA PS 1-3

    • Patients undergoing general anesthesia using the Supraglottic airway device

    • Patient's weight: 10-30kg

    Exclusion Criteria:

    • Patients who refused to participate in the study

    • Patients with tumors in the esophagus or esophageal varices

    • Patients with a monitoring device inserted through the esophagus during surgery

    • Patients with ear inflammation

    • Patients with congenital anomaly in the rectum

    • Patients judged unfit to participate in the study by medical staff for other reasons

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Asan Medical Center Seoul Korea, Republic of 05505

    Sponsors and Collaborators

    • Asan Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hajung Kim, Clinical assistant professor, Asan Medical Center
    ClinicalTrials.gov Identifier:
    NCT05705206
    Other Study ID Numbers:
    • 2020-1695
    First Posted:
    Jan 30, 2023
    Last Update Posted:
    Jan 30, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Body Temperature Changes

    Study Results

    No Results Posted as of Jan 30, 2023