Optimal Depth for Esophageal Stethoscope

Not Applicable

Active, not recruiting

• Conditions: Surgery
• Interventions: Device: Esophageal temperature monitoring according to the depth; Other: Anatomical landmark

• Registration Number: NCT05552092
• Lead Sponsor: Chosun University Hospital

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-09-14
• Study First Submitted QC: 2022-09-20
• Study First Posted: 2022-09-23
• Study Start: 2022-11-26
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-22
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Anatomical landmark	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.
Experimental	Esophageal temperature monitoring according to the depth	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.

Primary Outcome Measures

Name	Time	Method
Desired insertion depth of ES thermistor	1 day	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.

Secondary Outcome Measures

Name	Time	Method
Correlation analysis	Through study completion, 1 year	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.
Optimal depth analysis	Through study completion, 1 year	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.

Trial Locations

Locations (1)

Chosun University Hospital; 🇰🇷 Gwangju, Korea, Republic of