Accuracy of Body Temperature Measurements Using the Esophageal Temperature Probe Inserted Through the Gastric Lumen of Supraglottic Airway Device
1 other identifier
observational
35
1 country
1
Brief Summary
In general, 50-90% of patients undergoing surgery under general anesthesia are known to develop hypothermia during surgery. Due to hypothermia during surgery, the patient may cause coagulation disorders, wound infections, increased ventricular tachycardia, prolonged anesthesia drug effects, and electrification, resulting in delayed recovery after surgery, extended recovery room exit, and extended hospital stay. Therefore, unless intentional hypothermia is needed, active body temperature management during surgery is necessary. Pulmonary artery, distal esophagus, tympanic membrane, nasopharynx, oral cavity, axillary cavity, rectum, and bladder can be measured. The most accurate method for measuring deep body temperature in general anesthesia is esophageal body temperature, nasopharyngeal body temperature, It is known as tympanic body temperature. 3,4 However, the tympanic body temperature has the disadvantage that it cannot be continuously measured. Considering these points, esophageal thermometers that can be continuously measured in patients with general anesthesia and have few side effects are commonly used. The esophageal thermometer is usually inserted through the oral cavity. When the supraglottic airway device is inserted, the space in the oral cavity is filled with the supraglottic airway device, making it difficult to mount the esophageal thermometer. However, most second-generation supraglottic airway devices have gastric lumens, and gastric lumens are connected to the esophagus, allowing esophageal thermometers to be mounted through this space. Since the esophageal temperature probe is inserted in all general anesthesia patients using the supraglottic airway device in this application, the body temperature measured by the temporal artery at the same time is how accurate the body temperature measured at this time is as a reference value using the tympanic membrane. I would like to analyze the transient comparison. We will also analyze whether the esophageal thermometer mounted through the gastric lumen of the supraglottic airway device reflects the rapidly decreasing body temperature change when the pneumatic tourniquet is decompressed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 8, 2020
CompletedFirst Submitted
Initial submission to the registry
July 17, 2020
CompletedFirst Posted
Study publicly available on registry
July 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 16, 2020
CompletedJanuary 7, 2021
January 1, 2021
2 months
July 17, 2020
January 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
esophageal temperature
'c
10min
Eligibility Criteria
Among patients undergoing knee surgery using tourniquet for more than 1 hour, patients undergoing general anesthesia using the Supraglottic airway device
You may qualify if:
- Adults 19 to 80 Patients with ASA PS 1-3 Among patients undergoing knee surgery using tourniquet for more than 1 hour, patients undergoing general anesthesia using the Supraglottic airway device
You may not qualify if:
- Patients who refuse to participate in the study Patients with esophageal tumors or varicose veins Patients who are inserted through the esophagus during surgery Patients with ear inflammation Patients who have been deemed unsuitable for participation by the medical staff for other reasons
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sojin Shinlead
Study Sites (1)
asanMC
Seoul, Song-pa, South Korea
Study Officials
- STUDY CHAIR
wonwook ko, professor
Asan Medical Center
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- fellow
Study Record Dates
First Submitted
July 17, 2020
First Posted
July 24, 2020
Study Start
July 8, 2020
Primary Completion
September 15, 2020
Study Completion
September 16, 2020
Last Updated
January 7, 2021
Record last verified: 2021-01