NCT05705206

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 30, 2023

Completed
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

12 months

First QC Date

January 20, 2023

Last Update Submit

September 5, 2023

Conditions

Temperature Change, BodySupraglottic Airway DevicePediatric ALL

Outcome Measures

Primary Outcomes (1)

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

    'c

    10min

Secondary Outcomes (1)

  • Effect of gastric suction through an esophageal temperature probe

    After inserting the esophageal temperature probe

Eligibility Criteria

AgeUp to 6 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

MeSH Terms

Conditions

Body Temperature ChangesPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

January 20, 2023

First Posted

January 30, 2023

Study Start

March 25, 2021

Primary Completion

March 16, 2022

Study Completion

March 16, 2022

Last Updated

September 7, 2023

Record last verified: 2023-09

Locations

KR(1)