Optimal Depth for Esophageal Stethoscope

NCT05552092 | Recruiting

• 1 other identifier: ET_Position
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgery

Keywords

Anatomic Landmarks; Body Temperature; Monitoring, Intraoperative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Correlation analysis

  Through study completion, 1 year

• Optimal depth analysis

  Through study completion, 1 year

Study Arms (1)

Experimental

EXPERIMENTAL

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.

Device: Esophageal temperature monitoring according to the depth; Other: Anatomical landmark

Interventions

Anatomical landmark OTHER

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.

Experimental

Esophageal temperature monitoring according to the depth DEVICE

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.

Experimental

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chosun University Hospital: lead

Study Sites (1)

Chosun University Hospital

Gwangju, 61453, South Korea

RECRUITING

Related 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.

  PMID: 26974019 RESULT

Study Officials

• Ki Tae Jun, M.D., Ph.D.

  Chosun University Hospital

  STUDY DIRECTOR

Central Study Contacts

Ki Tae Jung, M.D., Ph.D.

CONTACT

+82-62-220-3223; mdmole@chosun.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 23, 2022
• Study Start: November 26, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)