Accuracy and Precision Comparison of Temptraq

NCT03264833 | Completed Results

• 1 other identifier: NCT-03264833
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.To assess the accuracy of the Temp-Traq thermometer as compared to a gold standard (Core temp measured by Pulmonary Artery Catheter)
2. 2.To assess the precision of the Temp-Traq thermometer over repeated measures
3. 3.To determine if accuracy \&/or precision is consistent in three conditions (hypothermia, normothermia, or hyperthermia)

Conditions

Temperature

Outcome Measures

Primary Outcomes (1)

• Temperature Comparison

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

  Multiple time points up to 6 hours post thermometer placement

Interventions

TempTraq DIAGNOSTIC_TEST

sensor-based external thermometer withmonitoring capability

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

To address the specific aims of this study the investigators will identify at least 40 patients who have a pulmonary artery (PA) catheter in place (patients in intensive care units).

You may not qualify if:

• 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

Sponsors & Collaborators

• Blue Spark Technologies: collaborator
• The Cleveland Clinic: lead

Related Publications (5)

• Eliades, A, Stoner, K. and Frisone, J. (unpublished paper) Use of skin patch device to obtain temperature measurements

  BACKGROUND

• Farnell S, Maxwell L, Tan S, Rhodes A, Philips B. Temperature measurement: comparison of non-invasive methods used in adult critical care. J Clin Nurs. 2005 May;14(5):632-9. doi: 10.1111/j.1365-2702.2004.00916.x.

  PMID: 15840078 BACKGROUND

• Lawson L, Bridges EJ, Ballou I, Eraker R, Greco S, Shively J, Sochulak V. Accuracy and precision of noninvasive temperature measurement in adult intensive care patients. Am J Crit Care. 2007 Sep;16(5):485-96.

  PMID: 17724246 BACKGROUND

• Pinsky MR, Vincent JL. Let us use the pulmonary artery catheter correctly and only when we need it. Crit Care Med. 2005 May;33(5):1119-22. doi: 10.1097/01.ccm.0000163238.64905.56.

  PMID: 15891346 BACKGROUND

• Sund-Levander M, Grodzinsky E. Assessment of body temperature measurement options. Br J Nurs. 2013 Aug 8-Sep 12;22(15):880, 882-8. No abstract available.

  PMID: 24052967 BACKGROUND

Results Point of Contact

• Title: Dr Sandra L. Siedlecki
• Organization: Cleveland Clinic

siedles@ccf.org

216-444-3896

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Nurse Scientist

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: August 29, 2017
• Study Start: December 15, 2016
• Primary Completion: September 1, 2017
• Study Completion: October 1, 2017
• Last Updated: February 12, 2026
• Results First Posted: February 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share