Trial Outcomes & Findings for Temperature Monitoring in Cardiac Surgery: Agreement Between Different Clinical Methods (NCT NCT04355013)

Last Updated: 2025-05-07

Results Overview

Agreement between core temperatures obtained in arterial CPB output versus venous inlet of CPB, bladder, pulmonary artery, nasopharynx and forehead (Tcore). The measurements were compared between the different methods using the Bland-Altman method of repeated measures and expressed as mean difference (reference method-alternative method) plus CI95%.

Recruitment status

COMPLETED

Target enrollment

48 participants

Primary outcome timeframe

24 temperature measures per patient recorded at 5-min intervals for each method and averaged using the Bland-Altman method for repeated measures

Results posted on

2025-05-07

Participant Flow

Adult patients undergoing cardiac surgery using cardiopulmonary bypass and requiring hemodynamic monitoring by means of a pulmonary artery catheter.

Exclusion criteria were sepsis or previous fever, presence of a previous standard urinary bladder catheter (without thermistor) inserted prior to surgery, moderate hypothermic cardiopulmonary bypass, or deep hypothermic circulatory arrest.

Participant milestones

Participant milestones
Measure	Patients Undergoing CPB Cardiac Surgery. Adult patients undergoing cardiac surgery using cardiopulmonary bypass and requiring hemodynamic monitoring by means of a pulmonary artery catheter.
Overall Study STARTED	48
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Undergoing CPB Cardiac Surgery. n=48 Participants Adult patients undergoing cardiac surgery using cardiopulmonary bypass and requiring hemodynamic monitoring by means of a pulmonary artery catheter.
Age, Continuous	66 years n=48 Participants
Sex: Female, Male Female	17 Participants n=48 Participants
Sex: Female, Male Male	31 Participants n=48 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=48 Participants
Race (NIH/OMB) Asian	0 Participants n=48 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=48 Participants
Race (NIH/OMB) Black or African American	0 Participants n=48 Participants
Race (NIH/OMB) White	48 Participants n=48 Participants
Race (NIH/OMB) More than one race	0 Participants n=48 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=48 Participants
Weight	70 kilograms n=48 Participants
Height	165 centimeters n=48 Participants

PRIMARY outcome

Timeframe: 24 temperature measures per patient recorded at 5-min intervals for each method and averaged using the Bland-Altman method for repeated measures

Outcome measures

Outcome measures
Measure	Arterial Outlet n=48 Participants Temperature in CPB arterial outlet	Nasopharyngeal n=48 Participants Temperature in nasopharynx	Bladder n=48 Participants Temperature in bladder	Tcore n=48 Participants Skin temperature measure with Tcore	Venous Inflow n=48 Participants CPB venous inflow temperature
Agreement Between Different Core Temperature Methods	35.0 celsius degrees (mean difference) Interval 34.9 to 35.0	35.2 celsius degrees (mean difference) Interval 35.1 to 35.3	35.6 celsius degrees (mean difference) Interval 35.5 to 35.6	34.8 celsius degrees (mean difference) Interval 34.7 to 35.0	34.8 celsius degrees (mean difference) Interval 34.7 to 34.9

Adverse Events

No Adverse Effects Were Measured

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. José A. Sastre

University Hospital of Salamanca

Phone: +34923291100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place