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

Completed

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

• Registration Number: NCT05705206
• Lead Sponsor: Asan Medical Center

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.

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 Timeline

• Study Start: 2021-03-25
• Primary Completion: 2022-03-16
• Study Completion: 2022-03-16
• Study First Submitted: 2023-01-20
• Study First Submitted QC: 2023-01-20
• Study First Posted: 2023-01-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-05
• Last Update Posted: 2023-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of esophageal temperature and temperature at tympanic membrane, rectum, temporal artery	10min	'c

Secondary Outcome Measures

Name	Time	Method
Effect of gastric suction through an esophageal temperature probe	After inserting the esophageal temperature probe	Evaluated via gastric sonography

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of