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Optimal Depth for Esophageal Stethoscope

Optimal Depth for Esophageal Stethoscope for the Monitoring of Core Temperature

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05552092
Enrollment
40
Registered
2022-09-23
Start date
2022-11-26
Completion date
2026-07-13
Last updated
2026-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery

Keywords

Anatomic Landmarks, Body Temperature, Monitoring, Intraoperative

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.

Interventions

DEVICEEsophageal 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.

OTHERAnatomical 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.

Sponsors

Chosun University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Desired insertion depth of ES thermistor1 dayTo 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

MeasureTime frameDescription
Correlation analysisThrough study completion, 1 yearThe 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. Radiographic landmarks On the preoperative chest radiograph, the cricoid-to-carina distance (CCD) and the carina-to-T8/9-intervertebral-disc distance (CDD) will be measured.
Optimal depth analysisThrough study completion, 1 yearWe 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. To quantify tolerance to positioning error, the difference was modeled as a quadratic function of the offset from the MHS position (depth - MHS) using a linear mixed-effects model with a random intercept per patient. From the fixed-effect curve and the total (within- plus between-patient) standard deviation, the probability that a single reading fell within ±0.5 °C of core was computed across offsets to define ≥90% and ≥85% "safe zones."

Countries

South Korea

Contacts

STUDY_DIRECTORKi Tae Jun, M.D., Ph.D.

Chosun University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 22, 2026