Core TemperatureNCT04485923
Accuracy of Body Temperature Measurements Using the Esophageal Temperature Probe Inserted Through the Gastric Lumen of Supraglottic Airway Device
An observational study of Core Temperature, run by Sojin Shin at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Core Temperature
- How many people
- 35 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Jul 2020to 16 Sep 2020
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Among patients undergoing knee surgery using tourniquet for more than 1 hour, patients undergoing general anesthesia using the Supraglottic airway device
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Basic anesthesia management is the same as for patients undergoing general anesthesia using all supraglottic airway devices.
Fasting from midnight the day before surgery, and when the patient enters the operating room, a blood pressure monitor, electrocardiogram, pulse saturator is mounted, and baseline blood pressure, oxygen saturation, and heart rate are recorded. As an anesthesia-inducing facial mask, it provides 100% of 4-6L/min of oxygen. Propofol is administered at 2 mg/kg, and after the patient's self-breathing is lost, 5% sevoflurane is supplied for 3 minutes to deepen the depth of anesthesia. After inserting the appropriate size of supraglottic airway (i-gel) according to the patient's weight, the esophageal temperature probe is inserted through the gastric lumen to the end of the supraglottic airway device i-gel. After 10 minutes, when the body temperature measurement measured in the esophagus stabilizes, the body temperature is measured at the tympanic membrane and temporal artery at 10-minute intervals. For the objectivity of body temperature measurement, the same operator performs it, and the left and right sides of the tympanic membrane can be measured differently, so both sides are measured and averaged. After Tourniquet deflation, body temperature is measured and recorded every 10 minutes from 10 minutes.
- Conditions
- Core Temperature
- Keywords
- core temperature, tympanic membrane, esophageal temperature, temporal artery temperature
What is being measured
The primary outcome is the main question the study is designed to answer.
esophageal temperature
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Measured: 10min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start8 Jul 2020
- Primary completion15 Sep 2020
- Study completion16 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Core TemperatureStudies of the same condition, open and under way.
- 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sojin Shin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sojin Shin, Asan Medical Center
- Investigators
- wonwook ko, professor, Study chair, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485923
- Sponsor's protocol ID
- SGA_temp_adult
- Status last verified
- Jan 2021
- First submitted
- 17 Jul 2020
- Last updated
- 7 Jan 2021
- Results posted
- No
- 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 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Body Temperature Measurements Using the Esophageal Temperature Probe Inserted Through the Gastric Lumen of Supraglottic Airway Device
- ClinicalTrials.gov ID
- NCT04485923
- Acronym / sponsor ID
- SGA_temp_adult
- Conditions
- Core Temperature
- Keywords
- core temperature, tympanic membrane, esophageal temperature, temporal artery temperature
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Sojin ShinUniversity, hospital or other
- Study start
- 8 Jul 2020 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 16 Sep 2020 (actual)
- First posted
- 24 Jul 2020 (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 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.
Detailed description
Basic anesthesia management is the same as for patients undergoing general anesthesia using all supraglottic airway devices.
Fasting from midnight the day before surgery, and when the patient enters the operating room, a blood pressure monitor, electrocardiogram, pulse saturator is mounted, and baseline blood pressure, oxygen saturation, and heart rate are recorded. As an anesthesia-inducing facial mask, it provides 100% of 4-6L/min of oxygen. Propofol is administered at 2 mg/kg, and after the patient's self-breathing is lost, 5% sevoflurane is supplied for 3 minutes to deepen the depth of anesthesia. After inserting the appropriate size of supraglottic airway (i-gel) according to the patient's weight, the esophageal temperature probe is inserted through the gastric lumen to the end of the supraglottic airway device i-gel. After 10 minutes, when the body temperature measurement measured in the esophagus stabilizes, the body temperature is measured at the tympanic membrane and temporal artery at 10-minute intervals. For the objectivity of body temperature measurement, the same operator performs it, and the left and right sides of the tympanic membrane can be measured differently, so both sides are measured and averaged. After Tourniquet deflation, body temperature is measured and recorded every 10 minutes from 10 minutes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Among patients undergoing knee surgery using tourniquet for more than 1 hour, patients undergoing general anesthesia using the Supraglottic airway device
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
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
esophageal temperature
Time frame: 10min
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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 Jan 2021.
- 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.
wonwook ko, professor study chair
Asan Medical Center
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 Core Temperature, run by Sojin Shin 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 1 inclusion and 1 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 Jan 2021. 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?
esophageal temperature (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 Jan 2021.