NCT04485923

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

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2020

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

July 8, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2020

Completed
Last Updated

January 7, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

July 17, 2020

Last Update Submit

January 5, 2021

Conditions

Keywords

core temperature, tympanic membrane, esophageal temperature, temporal artery temperature

Outcome Measures

Primary Outcomes (1)

  • esophageal temperature

    'c

    10min

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Study Sites (1)

asanMC

Seoul, Song-pa, South Korea

Location

Study Officials

  • wonwook ko, professor

    Asan Medical Center

    STUDY CHAIR

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

Locations