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CompletedNCT05595616TVPUpdated Sep 8, 2023

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

An observational study in Coronary Artery Disease, sponsored by Pusan National University Yangsan Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-08.

Sponsored by Pusan National University Yangsan Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
12
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Coronary Artery Disease
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 12 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Pusan National University Yangsan Hospital is the lead sponsor of 106 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients over 18-year-old undergoing coronary artery bypass surgery using pulmonary artery catheter

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Emergency surgery
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
12 participants (actual)
Patient registry
No

Interventions

  • DeviceInsertion 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Tracheal temperature and pulmonary arterial temperature are measured every 5 minutes for 1 hour after induction of general anesthesia.

07

Study locations

1 site
  • Pusan National University Yangsan Hospital
    Yangsan, Kyungnam 50612, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05595616
Lead sponsor
Pusan National University Yangsan Hospital
Responsible party
Park Seyeon, MD (Clinical assistant professor, Pusan National University Yangsan Hospital) — Principal investigator
First posted
Oct 27, 2022
Start date
Sep 20, 2022
Primary completion
Dec 31, 2022
Completion
Aug 31, 2023
Last update
Sep 8, 2023

Study contacts

Seyeon Park, MD
principal investigator · PNUYH, 20 Geumo-ro, Beomeo-ri, Mulgeumeup, 50612, Yangsan, Korea

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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