NCT05737147

Brief Summary

In this study, we aim to compare the core temperature measured with two noninvasive ZHF thermometers and a urinary bladder thermometer against a gold standard blood temperature measured in the pulmonary artery in patients undergoing on-pump cardiac surgery. Additionally we intend to compare the reproducibility of the ZHF measurements by using two devices simultaneously in each patient.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
Last Updated

March 17, 2023

Status Verified

March 1, 2023

Enrollment Period

2.1 years

First QC Date

February 12, 2023

Last Update Submit

March 16, 2023

Conditions

Temperature MonitoringCardiac Surgical Procedures

Keywords

ThermometersThoracic surgeryPerioperative monitoringTemperature monitoringAnesthesiaBody temperatureCardiac surgical procedures

Outcome Measures

Primary Outcomes (4)

  • ZHF temperature right side versus PAC temperature.

    ZHF temperature measured on the right side of the forehead versus PAC temperature.

    Perioperatively

  • ZHF temperature left side versus PAC temperature.

    ZHF temperature measured on the left side of the forehead versus PAC temperature.

    Perioperatively

  • ZHF temperature right side versus ZHF temperature left side

    ZHF temperature measured on the right side of the forehead versus ZHF temperature measured on the left side of the forehead

    Perioperatively

  • Bladder temperature versus PAC temperature

    Bladder temperature versus PAC temperature

    Perioperatively

Study Arms (1)

100 adult patients of both genders scheduled for cardiac surgery

100 adult patients of both genders scheduled for cardiac surgery with CPB for either coronary artery bypass grafting (CABG), aortic valve replacement (AVR), mitral valve replacement (MVR) or CABG + AVR.

Device: Zero Heat Flux Thermometer

Interventions

Zero Heat Flux ThermometerDEVICE

Comparison of the accuracy and precision of a Zero Heat Flux Thermometer (SpotOn) Versus Pulmonary Artery Temperature Measurement

Also known as: Pulmonary Artery Temperature
100 adult patients of both genders scheduled for cardiac surgery

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients of both genders scheduled for cardiac surgery with CPB for either coronary artery bypass grafting (CABG), aortic valve replacement (AVR), mitral valve replacement (MVR) or CABG + AVR

You may qualify if:

  • Adult patients of both genders scheduled for cardiac surgery with CPB for either coronary artery bypass grafting (CABG), aortic valve replacement (AVR), mitral valve replacement (MVR) or CABG + AVR

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet, Copenhagen University Denmark

Copenhagen, 2100, Denmark

Location

Study Officials

  • Carsten M. Pedersen, CRNA, MScN

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical nurse specialist

Study Record Dates

First Submitted

February 12, 2023

First Posted

February 21, 2023

Study Start

September 1, 2018

Primary Completion

October 1, 2020

Study Completion

July 1, 2022

Last Updated

March 17, 2023

Record last verified: 2023-03

Locations

DK(1)