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

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

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.

Study Overview

• Status: Completed
• Conditions: Pediatric ALL; Temperature Change, Body; Supraglottic Airway Device

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 Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 years (Child)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Pediatrics patients under six years old patients undergoing general anesthesia using the Supraglottic airway device

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of esophageal temperature and temperature at tympanic membrane, rectum, temporal artery	'c	10min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of gastric suction through an esophageal temperature probe	Evaluated via gastric sonography	After inserting the esophageal temperature probe

Collaborators and Investigators

• Sponsor: Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2021
• Primary Completion (Actual): March 16, 2022
• Study Completion (Actual): March 16, 2022

Study Registration Dates

• First Submitted: January 20, 2023
• First Submitted That Met QC Criteria: January 20, 2023
• First Posted (Actual): January 30, 2023

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Temperature Changes
• Other Study ID Numbers: 2020-1695

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No