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NCT05705206 Clinical Trial

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

Pediatric ALL Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05705206
Other study ID # 2020-1695
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 25, 2021
Est. completion date March 16, 2022

Study information
Verified date September 2023
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 42
Est. completion date March 16, 2022
Est. primary completion date March 16, 2022
Accepts healthy volunteers
Gender All
Age group N/A to 6 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comparison of esophageal temperature and temperature at tympanic membrane, rectum, temporal artery 'c 10min
Secondary Effect of gastric suction through an esophageal temperature probe Evaluated via gastric sonography After inserting the esophageal temperature probe
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