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
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Body Temperature Changes
• Pediatric ALL
• Supraglottic Airway Device
• Temperature Change, Body

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