The Patients Who Underwent General AnesthesiaNCT04817943
Comparison of Esophageal and Tracheal Temperature in the Patients Using Breathing Circuit With Heated Wire Humidifier
An observational study of The Patients Who Underwent General Anesthesia, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- The Patients Who Underwent General Anesthesia
- What is being tested?
- Non applicable
- Type of treatment
- Injection or infusion
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Apr 2021to 31 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Being tested
- Non applicable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non applicableOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Esophageal and tracheal temperature measurement
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
Measured: during operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start29 Apr 2021
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Patients Who Underwent General AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Hee Young, Pusan National University Yangsan Hospital
- Investigators
- Hee Young Kim, MD, PhD, Principal investigator, Department of Anesthesia and Pain Medicine, School of Medicine, Pusan National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817943
- Sponsor's protocol ID
- 05-2021-028
- Status last verified
- Jan 2024
- First submitted
- 23 Mar 2021
- Last updated
- 16 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Esophageal and Tracheal Temperature in the Patients Using Breathing Circuit With Heated Wire Humidifier
- ClinicalTrials.gov ID
- NCT04817943
- Acronym / sponsor ID
- 05-2021-028
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Age groups
- Adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non applicableWhen 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. | Other | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hee Young Kim, MD, PhD principal investigator
Department of Anesthesia and Pain Medicine, School of Medicine, Pusan National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of The Patients Who Underwent General Anesthesia, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Esophageal and tracheal temperature measurement (time frame: during operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.