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

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: Not yet recruiting
• Conditions: Patients With Laryngeal Microsurgery

• Study Type: Observational
• Enrollment (Anticipated): 56

Contacts and Locations

• Study Contact: Name: HYO JIN BYON; Phone Number: 82-10-9134-1566; Email: jinoben@naver.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

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	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

Outcome Measure	Measure Description	Time Frame
The maximum difference between esophageal and bronchial temperatures before and after cervical hyperplasia	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

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: November 2, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (Actual): November 8, 2022

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID 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