ClinicalTrials.gg
CompletedNCT05705206Updated Sep 7, 2023

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

An observational study in Temperature Change, Body, Supraglottic Airway Device and Pediatric ALL, sponsored by Asan Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged Up to 6 Years. Per ClinicalTrials.gov, last updated 2023-09-07.

Sponsored by Asan Medical Center · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
42
Ages
Up to 6 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Temperature Change, Body
  • Supraglottic Airway Device
  • Pediatric ALL
03

In context

Body Temperature Changes

97 studies on the registry are indexed under Body Temperature Changes; 20 are open to participants now.

This study's enrollment of 42 is below the median of 87 across 24 observational studies indexed under Body Temperature Changes.

Browse Body Temperature Changes studies →

Lead sponsor

Asan Medical Center is the lead sponsor of 578 studies on the registry; 73 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 6 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Pediatrics patients under six years old with 1-3
  • Patients undergoing general anesthesia using the Supraglottic airway device
  • Patient's weight: 10-30kg

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
42 participants (actual)
Target follow-up
1 Day
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Comparison of esophageal temperature and temperature at tympanic membrane, rectum, temporal artery

    'c

    Time frame: 10min

Secondary outcomes

  1. Effect of gastric suction through an esophageal temperature probe

    Evaluated via gastric sonography

    Time frame: After inserting the esophageal temperature probe

07

Study locations

1 site
  • Asan Medical Center
    Seoul, 05505, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05705206
Responsible party
Hajung Kim (Clinical assistant professor, Asan Medical Center) — Principal investigator
First posted
Jan 30, 2023
Start date
Mar 25, 2021
Primary completion
Mar 16, 2022
Completion
Mar 16, 2022
Last update
Sep 7, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion