Comparison of Temperature Using Tracheal Thermometer and Pulmonary Artery Catheter in Adult Patients Undergoing CABG

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT05595616
• Lead Sponsor: Pusan National University Yangsan Hospital

Brief Summary

In anesthesia, monitoring of core body temperature is one of important factors. Measurement of temperature using a pulmonary artery catheter is representative one of core temperature measurements. The core temperature by a pulmonary artery catheter is compared with the tracheal temperature by an endotracheal tube with thermometer. This study was designed to confirm the accuracy of the endotracheal tube thermometer.

Detailed Description

All patients undergoing general anesthesia are monitored core body temperature. Coronary artery bypass graft surgery needs general anesthesia with endotracheal intubation and insertion of pulmonary artery catheter. Using endotracheal tube with thermometer and pulmonary artery catheter, the investigators will measure tracheal temperature and pulmonary artery temperature every 5 minutes for 1 hour after induction of general anesthesia.

Standard monitoring devices (non-invasive BP, electrocardiogram, pulse oxygen saturation) are applied to participants in an operation room, and 1% propofol 1-2 mg/kg and rocuronium 0.8 mg/kg are administered intravenously for induction of general anesthesia. An endotracheal tube with thermometer (Human Endotracheal Tube, Insung Medical Co., Korea) is inserted. After inserting a 9Fr central venous catheter with a pulmonary artery catheter insertion port, core body temperature is measured by a pulmonary artery catheter (Swan-Ganz CCOmbo V, Edwards Lifesciences, Irvine, California, USA).

Tracheal temperature will be compared with pulmonary artery temperature by using Bland-Altman method.

Study Timeline

• Study Start: 2022-09-20
• Study First Submitted: 2022-10-19
• Study First Submitted QC: 2022-10-25
• Study First Posted: 2022-10-27
• Primary Completion: 2022-12-31
• Study Completion: 2023-08-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Adult patients over 18-year-old undergoing coronary artery bypass surgery

Exclusion Criteria

• Emergency surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of tracheal temperature versus pulmonary artery temperature	Tracheal temperature and pulmonary arterial temperature are measured every 5 minutes for 1 hour after induction of general anesthesia.	This study compares core body temperature measured by a pulmonary artery catheter and temperature measured by an endotracheal tube with a thermometer.; Additional description\> Time points or intervals are not important factors in this study. The study needs repeated measurements using method A (tracheal thermometer) and method B (pulmonary artery thermometer). Then it compares tracheal temperature with pulmonary artery temperature, and checks the agreement of method A and B.

Trial Locations

Locations (1)

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Kyungnam, Korea, Republic of