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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04817943
Recruitment Status : Recruiting
First Posted : March 26, 2021
Last Update Posted : June 18, 2021
Sponsor:
Information provided by (Responsible Party):
Kim Hee Young, Pusan National University Yangsan Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
The Patients Who Underwent General Anesthesia Other: Non applicable

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Esophageal and Tracheal Temperature in the Patients Using Breathing Circuit With Heated Wire Humidifier
Actual Study Start Date : April 29, 2021
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Intervention Details:
  • Other: Non applicable
    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 Outcome Measures :
  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



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Among the patients undergoing surgery that requires more than 2 hours of general anesthesia and the use of a breathing circuit with heated wire humidifier
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04817943


Locations
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Korea, Republic of
Pusan National University Yangsan Hospital Recruiting
Yangsan, Korea, Republic of
Contact: Hee Young Kim, MD, PhD    82553602129    yuvi1981@naver.com   
Sponsors and Collaborators
Pusan National University Yangsan Hospital
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Responsible Party: Kim Hee Young, Clinical associate professor, Pusan National University Yangsan Hospital
ClinicalTrials.gov Identifier: NCT04817943    
Other Study ID Numbers: 05-2021-028
First Posted: March 26, 2021    Key Record Dates
Last Update Posted: June 18, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes