N/A
N=60
Accuracy and Precision Comparison of Temptraq
Temperature
Bottom Line
View on ClinicalTrials.gov: NCT03264833 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Temperature Comparison — -0.60; -0.24; -0.16; -0.19 Degree Celsius
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- TempTraq (Diagnostic_test)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Temperature Comparison |
-0.60; -0.24; -0.16; -0.19; -0.30 | — |
Summary
Purpose The purpose of this feasibility study is to assess the accuracy and precision of the Temp-Traq thermometer for monitoring body temperature in adult patients under three conditions (hypothermia, normothermia, and hyperthermia).
Specific Aims
1. To assess the accuracy of the Temp-Traq thermometer as compared to a gold standard (Core temp measured by Pulmonary Artery Catheter)
2. To assess the precision of the Temp-Traq thermometer over repeated measures
3. To determine if accuracy &/or precision is consistent in three conditions (hypothermia, normothermia, or hyperthermia)
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria Adult patient (male or female) in intensive care unit who will have a PA catheter in place for at least the next 8 hours; and who have no visible skin condition to the axillary region upon inspection by the research nurse are eligible for this study
Exclusion Criteria
- Patients younger than 21
- Patients who will not have a PA catheter in place for the next 8 hours
- Patients who have a visible skin condition to the axillary region upon inspection by the research nurse
- Patients who will be going for procedures or for some reason will not be available for the 6 hours of the study
Data sourced from ClinicalTrials.gov (NCT03264833). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.