Comparison of Tracheal Temperature Measured Using Endotracheal Tube (ETT) Thermometer Before and After Neck Hyperextension in Patients Undergoing Laryngeal Microsurgery

November 7, 2022 updated by: Yonsei University
After entering the operating room, the subject receives normal general anesthesia. The operating room temperature should be maintained at 20-25°C, and a blanket is covered and a bare warmer is applied to prevent the patient's body temperature from falling. Check the loss of consciousness due to the administration of intravenous anesthetics, and tracheostomy is performed with a tracheostomy tube (internal diameter: 7.5 mm for male patients and 6.5 mm for female patients) with a temperature measurement sensor embedded in the cuff surface 3 minutes after the administration of muscle relaxant. Immediately after the tracheal tube, air is injected into the cuff of the tracheal tube, and the pressure is 20 cmH2O or less. The depth of the tracheal tube is fixed to 24 cm for male patients and 22 cm for female patients based on teeth. After tracheal intubation, water ventilation is performed, and the end of exhalation carbon dioxide partial pressure (EtCO2) and chest movement are observed to confirm the success of tracheal intubation. Check whether the depth of the tracheal tube is appropriate through auscultation of the lung fields on both sides, and then start machine breathing. Apply a single breath (4-8 ml/kg, expected weight basis) to the mixed gas of oxygen (50%) and air (2L/min), and adjust the number of breaths per minute for EtCO2 40 cmH2O. In order to maintain anesthesia, sevoflurane and repeatanil are administered during surgery. During surgery, SpO2 is maintained at 95% or more, blood pressure and heart rate are maintained at ± 30% of blood pressure and heart rate just before anesthesia, and airway pressure is maintained at 35 cmH2O or less. To compare with the bronchial temperature measured by the bronchial tube thermometer, the esophageal thermometer is inserted to measure the esophageal body temperature. The depth of the esophageal thermometer is determined using the following formula derived from previous studies. Determination of esophageal probe insertion length based on standing and sitting height. (The esophageal thermometer depth (cm) = 0.228 x height - 0.194). Study the temperature measured by the bronchial tube thermometer and the esophageal thermometer. It is the bronchial body temperature measured with a bronchial tube thermometer before and after cervical overstretch. The tracheal body temperature before and after cervical overstretch is defined as the tracheal body temperature just before cervical overstretch and 5 minutes after overstretch, respectively. Record the maximum difference between esophageal and tracheal temperatures before and after cervical hyperplasia, from 5 minutes after bronchial tube thermometer and just before cervical hyperplasia, and from 5 minutes after cervical hyperplasia to end of surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

People who are scheduled to undergo laryngeal micro-surgery under general anesthesia at Yonsei University Severance Hospital.

Description

Inclusion Criteria:

  1. The American Anesthesiology Association's Systemic Condition Classification 1, 2, adult patients aged 19 or older, who are scheduled to perform general anesthesia for laryngeal microoperation
  2. If the study participant voluntarily decides to participate and agrees in writing after hearing and fully understanding the detailed explanation of this clinical study

Exclusion Criteria:

  1. In case the bronchial tube thermometer cannot be used for surgery
  2. If you have a history of cervical surgery
  3. In the case where neck overstretching for laryngeal microoperation is impossible
  4. If the body temperature measured before surgery is 37.6℃ or higher or 35.6℃ or lower
  5. Where the researcher determines that it is inappropriate to participate in clinical research due to other reasons;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of tracheal temperature measured using Endotracheal tube (ETT) thermometer before and after neck hyperextension in patients undergoing laryngeal microsurgery
Time Frame: up to 1 year
It is the bronchial body temperature measured with a bronchial tube thermometer before and after cervical overstretch. The tracheal body temperature before and after cervical overstretch is defined as the tracheal body temperature just before cervical overstretch and 5 minutes after overstretch, respectively.
up to 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The maximum difference between esophageal and bronchial temperatures before and after cervical hyperplasia
Time Frame: up to 1 year
The maximum difference between esophageal and bronchial temperatures before and after cervical hyperplasia is recorded when esophageal and bronchial temperatures differ the most from 5 minutes after bronchial tube thermometers and just before cervical hyperplasia to end of surgery.
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4-2022-0777

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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