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OpenTrials
Completed

NCT Number: NCT04817943

Comparison of Esophageal and Tracheal Temperature in the Patients Using Breathing Circuit With Heated Wire Humidifier

When using a breathing circuit with heated wire humidifier, investigators will check if the temperature measured by the thermometer of the endotracheal tube is more than 0.25 degrees apart from the temperature measured by the esophageal thermometer. Through this, in the case of patients who need to use a breathing circuit with heated wire humidifier, investigators will find out whether it is appropriate to use an esophageal or endotracheal thermometer.

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pusan National University Yangsan Hospital

Yangsan, South Korea

About this study

It is known that hypothermia occurs in approximately 50-90% of surgical patients under general anesthesia, and intraoperative hypothermia can lead to various complications such as wound infection, coagulation disorders, increased frequency of cardiac complications, ventricular fibrillation, prolonged effects of anesthesia drugs, shivering, and weakened immune function. Additionally, inadequate maintenance of temperature during surgery can result in delayed discharge from the recovery room, delayed recovery, and extended hospitalization. Therefore, accurate measurement of body temperature and active temperature management are crucial during surgery. Although there are various sites for temperature measurement, measuring the core body temperature in well-perfused deep tissues, which have a higher temperature and greater reliability than other sites, is essential. While esophageal temperature measurement is commonly used in patients undergoing general anesthesia, there may be cases where esophageal temperature probe cannot be inserted due to bleeding tendencies or lesions in the esophagus. In such cases, measuring temperature through the tympanic membrane or an endotracheal device becomes possible, but using a heated humidification breathing circuit for patient warming may affect the endotracheal temperature. Although there are animal study results comparing esophageal temperature and endotracheal temperature, research on the comparison of esophageal and endotracheal temperatures in humans is limited, and there is no study on the comparison of esophageal and endotracheal temperatures when using a heated humidification breathing circuit. The investigators aim to verify whether there is a temperature difference of 0.25 degrees or more between the temperature measured through the endotracheal device and the temperature measured by the esophageal thermometer when using a heated humidification breathing circuit. Through this investigation, they seek to determine which thermometer, either esophageal or endotracheal, is more appropriate to use in patients requiring the use of a heated humidification breathing circuit.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • males and females between the ages of 20 and 60 and meet the criteria for classification I and II of the American Society of Anesthesiology

Exclusion criteria

  • Patients with a predisposition for bleeding
  • Patients with a history of inability to insert an esophageal thermometer (esophageal varices, esophageal stenosis, esophageal malformation, and anatomical deformation after esophageal surgery)
  • pregnant woman

Treatment and study plan

Non applicable

Other

When the patient enters the operating room, oxygen saturation, blood pressure, and electrocardiogram are monitored, and general anesthesia is induced using 1-2 mg/kg of 1% propofol. 0.8 mg/kg of rocuronium, a neuromuscular blocker, is injected intravenously, and a human endotracheal tube is intubated. A thermometer is attached to the inside of the double-layered endotracheal tube cuff, which measures the temperature in the trachea. After the endotracheal intubation is performed, the esophageal thermometer is inserted, and from this point, the temperature measured by the esophageal thermometer and the thermometer of the endotracheal tube are recorded. The temperature immediately after insertion of the esophageal thermometer is set as Tbaseline, and the temperature of the esophagus and trachea, the temperature of the operating room, and the temperature of breathing circuit with heated wire humidifier are recorded every 5 minutes from thereafter until the end of the operation.

Primary outcomes

  1. Esophageal and tracheal temperature measurement

    Time frame: during operation

    Esophageal and tracheal temperature measurement in patients undergoing surgery that requires more than 2 hours of general anesthesia and the use of breathing circuit with heated wire humidifier

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 26, 2021
Registry last updated
Jan 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.