Temperature Change, BodyNCT05705206
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 of Temperature Change, Body and Supraglottic Airway Device, run by Asan Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Temperature Change, Body, Supraglottic Airway Device, Pediatric ALL
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Mar 2021to 16 Mar 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 years
- All sexes
- Child
Study population: Pediatrics patients under six years old patients undergoing general anesthesia using the Supraglottic airway device
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Medical subject headings
- Body Temperature Changes, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of esophageal temperature and temperature at tympanic membrane, rectum, temporal artery
'c
Measured: 10min
Secondary outcomes (1)
Effect of gastric suction through an esophageal temperature probe
Evaluated via gastric sonography
Measured: After inserting the esophageal temperature probe
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start25 Mar 2021
- Primary completion16 Mar 2022
- Study completion16 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temperature Change, BodyStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hajung Kim, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05705206
- Sponsor's protocol ID
- 2020-1695
- Status last verified
- Sep 2023
- First submitted
- 20 Jan 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05705206
- Acronym / sponsor ID
- 2020-1695
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 16 Mar 2022 (actual)
- Study completion
- 16 Mar 2022 (actual)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Age groups
- Child
- Study population
- Pediatrics patients under six years old patients undergoing general anesthesia using the Supraglottic airway device
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of esophageal temperature and temperature at tympanic membrane, rectum, temporal artery
Time frame: 10min
'c
1 secondary outcome
Effect of gastric suction through an esophageal temperature probe
Time frame: After inserting the esophageal temperature probe
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temperature Change, Body and Supraglottic Airway Device, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of esophageal temperature and temperature at tympanic membrane, rectum, temporal artery (time frame: 10min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.