Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03745079
Other study ID # MED-OBS-18-350
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 20, 2019
Est. completion date December 31, 2023

Study information

Verified date March 2023
Source Ajou University School of Medicine
Contact In Kyong Yi, MD
Phone +82312197522
Email lyrin01@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Core temperature should be monitored under general anesthesia. Recently developed 3M Spoton skin temeprature which is applied on temporal artery is correlated with core temperature measure by esophageal prove in several studies. Conventional skin temperature over carotid artery is also correlated with core temperature in several studies. The purpose of this study is comparing 3 methods of temperature monitoring. First, conventional core temperature measure by esophageal stethoscope. Second, 3M Spoton applying on temporal artery. Third, 3M Spoton applying on carotid artery


Description:

Core temperature should be monitored under general anesthesia. Because patients are prone to hypothermia during surgery. Conventional core temperature is monitored at esophagus, rectum, nasopharynx. But some of them are invasive and impossible in sometimes. Recently developed 3M Spoton skin temeprature which is applied on temporal artery is correlated with core temperature measured by esophageal prove in several studies. Its mechanism is making zero heat flux on skin applied. But it also cannot apply in head or facial surgery. Other studies showed conventional skin temperature over carotid artery is also correlated with core temperature. The investigators hypothesized using Spoton on carotid artery could be alternative method measuring core temperature. The purpose of this study is comparing 3 methods of temperature monitoring. First, conventional core temperature measure by esophageal stethoscope. Second, 3M Spoton applying on temporal artery. Third, 3M Spoton applying on carotid artery


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 31, 2023
Est. primary completion date December 30, 2023
Accepts healthy volunteers No
Gender All
Age group 19 Years to 60 Years
Eligibility Inclusion Criteria: - Age 19~60 years old - Who need surgery more than 2 hours under general anesthesia - American Society of Anesthesiologists physical status 1 or 2 Exclusion Criteria: - Body mass index < 35 - Head and neck surgery - Patients with fever > 38'C - History of malignant hyperthermia

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Esophagus temperature monitoring
Measuring core temperature by esophageal stethoscope
Spoton Temporal
Mesuring temperature on skin near to temporal artery using Spoton
Spoton Carotid
Mesuring temperature on skin near to carotidl artery using Spoton

Locations

Country Name City State
Korea, Republic of Ajou university school of medicine Suwon Gyeonggi-do

Sponsors (1)

Lead Sponsor Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Esophageal core temperature measured by stethoscope ? Temperature measured by esophageal stethoscope, ? 3 hours (during general anesthesia)
Primary Carotid skin temperature by SpotOn, ? Temperature measured by SpotOn near to carotid artery, ? 3 hours (during general anesthesia)
Primary Temporal skin temperature by SpotOn, ? Temperature measured by SpotOn near to temporal artery, ? 3 hours (during general anesthesia)
Secondary Room temperature, ? Operating room temperature, ? 3 hours (during general anesthesia)
See also
  Status Clinical Trial Phase
Completed NCT04577430 - Effects of Dexmedetomidine on Cardiac Electrophysiology in Patients Under General Anesthesia During Perioperative Period N/A
Completed NCT03708692 - Menstrual Cycle Phases on Recovery and Cognitive Function
Recruiting NCT03422315 - Population Pharmacokinetics and Clinical Individual Dosage Regimen of Propofoll Injection N/A
Completed NCT02771067 - The Utility of Pulse Pressure Variation to Predict the Fluid Responsiveness During Pneumoperitoneum and Reverse-Trendelenburg Position N/A
Completed NCT05063461 - Evaluation of the Analgesia Nociception Index With Varying Remifentanil Concentrations Under Sevoflurane N/A
Completed NCT03294226 - Comparison of AuraGain With I-gel for Pediatric Patients N/A
Not yet recruiting NCT03643029 - The Accuracy of the Performance and Placement Test for Predicting Supraglottic Airway Device (SAD) Position in the Hypopharynx as Confirmed With Video Laryngoscopy N/A
Completed NCT01945411 - Assessment of Facial Measurements, the Length of Mouth Corner-mandible Angle and Incisors-mandible Angle, for Determining the Proper Sizes of Oropharyngeal Airway N/A
Not yet recruiting NCT01678066 - A Prospective Study to Bilaterally Compare a Non-Invasive Cardiac Output Monitor N/A
Completed NCT01705743 - Minimum Alveolar Concentration of Sevoflurane With Nitrous Oxide Inducing Isoelectric EEG Phase 4
Completed NCT00972491 - The Optimal Time to Put Laryngeal Mask Airway in the Mouth Under General Anesthesia N/A
Completed NCT01096212 - Efficacy and Safety of Sevofran in Patients Scheduled for Elective Surgery Under General Anesthesia Phase 4
Completed NCT00741507 - Unhealthy Alcohol Drinking and Anesthetic Requirement in Women N/A
Completed NCT00599066 - Intraoperative M-Entropy Measurements N/A
Completed NCT00532402 - Continuous and Discontinuous Determination of Propofol Concentration in Breathing Gas N/A
Completed NCT00468494 - Can Blood Glucose Levels During the Perioperative Period Identify a Population at Risk for Hyperglycemia? N/A
Recruiting NCT00492453 - Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy N/A
Completed NCT04094376 - Comparison of Morning Operation and Evening Operation on Postoperative Sleep Quality and Pain Under General Anesthesia N/A
Enrolling by invitation NCT03672734 - Volume and pH of Gastric Contents in Patients Undergoing Gynecologic Laparoscopic Surgery During Emergence From General Anesthesia
Recruiting NCT04926220 - Dynamic Estimation of Cardiac Output in the Operating Room