Optimal Depth for Esophageal Stethoscope

Surgery Clinical Trial

Official title:

Optimal Depth for Esophageal Stethoscope for the Monitoring of Core Temperature

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05552092
• Other study ID #: ET_Position
• Status: Recruiting
• Phase: N/A
• Start date: November 26, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: February 2024
• Source: Chosun University Hospital
• Contact: Ki Tae Jung, M.D., Ph.D.
• Phone: +82-62-220-3223
• Email: mdmole[@]chosun.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the present study was to evaluate the optimal insertion depth of an esophageal stethoscope with a thermistor for core temperature monitoring.

Description:

Monitoring core temperature is crucial for maintaining normothermia during general anesthesia. During anesthesia, an esophageal stethoscope with a thermistor for monitoring esophageal temperature is frequently used. There are several researches on the depth or position of the esophageal stethoscopes, but there is only limited information (known as about 40-45 cm or T8-T9). The purpose of the present study was to evaluate the optimal insertion depth of an esophageal stethoscope with a thermistor for core temperature monitoring.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• The patients with ASA class 1-2 (20-65 years old) who are undergoing elective surgery with supine or lithotomy position, without position change scheduled to last more than 90 min.

Exclusion Criteria:

• anatomical abnormality with the upper airway
• risks of a difficult airway
• abnormal central anatomical structures such as airway, diaphragm, or spine on the chest X-ray
• history of disease or surgery on the stomach or esophagus
• risks of bleeding or coagulopathy on the preoperative laboratory results
• obese patients with BMI over 30
• contraindication to insertion of ES for the surgery
• who did not take a standing chest PA X-ray before surgery
• position change during the surgery
• open chest surgery

Related Conditions & MeSH terms

• Surgery

Intervention

Device:
• Esophageal temperature monitoring according to the depth
Core temperatures will be measured with a tympanic thermometer as a reference. When the tympanic membrane (TM) temperature is constant after measuring three consecutive times at 10 seconds intervals, the temperature will be assumed as the core body temperature. Initially, the esophageal stethoscope (ES) will be inserted to a depth of 45 cm from the incisor. After 30 minutes of monitoring, when the changes in the body temperatures stabilized, initial temperatures of the TM and ES thermistor will be assessed. After 5 minutes, ES will be taken out 2 cm back, and the temperatures of each site will be measured when the temperature change of the ES thermistor stabilized below 0.1°C. Eventually, the depth of ES will be changed from 45 to 27 cm with a 2 cm interval, and the temperature at each position will be measured.

Other:
• Anatomical landmark
For the further evaluation of the optimal insertion depth of GDT, anatomical landmarks such as distance from the cricoid cartilage to the carina (CCD) and distance from the carina to the intervertebral disc between T8 and T9 (CDD) will be measured using an electronic caliper on a preoperative chest X-ray.

Locations

Country	Name	City	State
Korea, Republic of	Chosun University Hospital	Gwangju

Sponsors (1)

Lead Sponsor	Collaborator
Chosun University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Wang M, Singh A, Qureshi H, Leone A, Mascha EJ, Sessler DI. Optimal Depth for Nasopharyngeal Temperature Probe Positioning. Anesth Analg. 2016 May;122(5):1434-8. doi: 10.1213/ANE.0000000000001213. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Desired insertion depth of ES thermistor	To evaluate the desired insertion depth, we will assess the accuracy of temperatures of the ES thermistor at each location by estimating the difference between the esophageal temperature using ES thermistor and the core body temperatures of TM.	1 day
Secondary	Correlation analysis	The secondary outcome of the study is to assess the correlation between the characteristics of patients including gender, height, weight, BMI, CCD, or CDD, and the actual insertion depth of the ES which showed the most minor difference in temperature between TM and ES thermistor.	Through study completion, 1 year
Secondary	Optimal depth analysis	We will calculate a mathematical model to predict the optimal insertion depth of ES for the esophageal temperature monitoring, and further analysis for the accuracy and correlation will be done.	Through study completion, 1 year