Trial Outcomes & Findings for Accuracy and Precision Comparison of Temptraq (NCT NCT03264833)

NCT ID: NCT03264833

Last Updated: 2026-02-12

Results Overview

Core temperature monitoring (degree Celsius) with temp-Traq thermometer compared to Pulmonary Artery (PA) catheter

Recruitment status

COMPLETED

Target enrollment

60 participants

Primary outcome timeframe

Multiple time points up to 6 hours post thermometer placement

Results posted on

2026-02-12

Participant Flow

Patients were recruited in a medical ICU over a 6 month period

Participant milestones

Participant milestones
Measure
Longitudinal Single Arm Study
Patients were assessed at baseline, hour 2, hour 4 and hour 6 Temperature (Celsius) data were compared between TempTraq reading and pulmonary artery (central, internal; used as the gold standard) readings at 4 time points
Overall Study
STARTED
60
Overall Study
COMPLETED
60
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Accuracy and Precision Comparison of Temptraq

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Longitudinal Single Arm Study
n=60 Participants
Medical ICU patients with a pulmonary artery catheter; obtained core temp (PA catheter) and compared to TempTraq temperatures in Celsius
Age, Continuous
65.8 years
STANDARD_DEVIATION 11.13 • n=41 Participants
Sex: Female, Male
Female
20 Participants
n=41 Participants
Sex: Female, Male
Male
40 Participants
n=41 Participants
Race/Ethnicity, Customized
White
40 participants
n=41 Participants
Race/Ethnicity, Customized
Black
20 participants
n=41 Participants
pulmonary artery catheter core temperature sensor
PA-Celsius
36.84 Degree Celsius
n=41 Participants
pulmonary artery catheter core temperature sensor
TempTraq- Celsius
36.3 Degree Celsius
n=41 Participants

PRIMARY outcome

Timeframe: Multiple time points up to 6 hours post thermometer placement

Population: Adults in a medical intensive care unit with pulmonary artery catheter monitoring that included core temperature

Core temperature monitoring (degree Celsius) with temp-Traq thermometer compared to Pulmonary Artery (PA) catheter

Outcome measures

Outcome measures
Measure
Longitudinal Single Arm Study
n=60 Participants
Mean differences in Core temperature (degree Celsius) monitoring with temp-Traq thermometer compared to Pulmonary Artery (PA) catheter
Temperature Comparison
Initial placement
-0.60 Degree Celsius
Interval -0.78 to -0.42
Temperature Comparison
2 hours post placement
-0.24 Degree Celsius
Interval -0.39 to -0.097
Temperature Comparison
4 hours post placement
-0.16 Degree Celsius
Interval -0.3 to -0.03
Temperature Comparison
6 hours post placement
-0.19 Degree Celsius
Interval -0.37 to -0.02
Temperature Comparison
Cumulative change
-0.30 Degree Celsius
Interval -0.39 to -0.22

Adverse Events

Longitudinal Single Arm Study

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 Sandra L. Siedlecki

Cleveland Clinic

Phone: 216-444-3896

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place