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

Coronary Artery Disease Clinical Trial

— TVP  

Official title:

Comparison of Core Temperature Using Tracheal Thermometer and Pulmonary Artery Catheter in Adult Patients Undergoing Coronary Artery Bypass Graft Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05595616
• Other study ID #: 2022-09-01
• Status: Completed
• Start date: September 20, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: September 2023
• Source: Pusan National University Yangsan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Emergency surgery

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• Insertion of tracheal thermometer and pulmonary artery catheter
Endotracheal intubation of endotracheal tube with thermometer (Human Endotracheal Tube, Insung Medical Co., Korea) and insertion of Swan-Ganz catheter

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Kyungnam

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of tracheal temperature versus pulmonary artery temperature	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.	Tracheal temperature and pulmonary arterial temperature are measured every 5 minutes for 1 hour after induction of general anesthesia.