Temperature Clinical Trial
Official title:
Accuracy and Precision Test of TempTraq® Compared to Pulmonary Artery Catheter for Monitoring Temperature in Adults in Intensive Care Unit
Verified date | August 2017 |
Source | The Cleveland Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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)
Status | Active, not recruiting |
Enrollment | 50 |
Est. completion date | September 1, 2017 |
Est. primary completion date | February 1, 2017 |
Accepts healthy volunteers | |
Gender | All |
Age group | 21 Years and older |
Eligibility |
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: 1. Patients younger than 21 2. Patients who will not have a PA catheter in place for the next 8 hours 3. Patients who have a visible skin condition to the axillary region upon inspection by the research nurse 4. Patients who will be going for procedures or for some reason will not be available for the 6 hours of the study |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic | Blue Spark Technologies |
Eliades, A, Stoner, K. and Frisone, J. (unpublished paper) Use of skin patch device to obtain temperature measurements
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. — View Citation
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. — View Citation
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. — View Citation
Sund-Levander M, Grodzinsky E. Assessment of body temperature measurement options. Br J Nurs. 2013 Aug 8-Sep 12;22(15):880, 882-8. Corrected and republished in: Br J Nurs. 2013 Sep 12-25;22(16):942, 944-50. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accuracy and precision of TempTraq thermometer- Baseline | Skin surface temperature readings measured in Celsius using Temp Traq vs measured by Temp Traq and by Pulmonary artery catheter core thermister | Baseline | |
Primary | Accuracy and precision of TempTraq thermometer-Time 2 | Skin surface temperature readings measured in Celsius using Temp Traq vs measured by Temp Traq and by Pulmonary artery catheter core thermister | 2 hours post baseline | |
Primary | Accuracy and precision of TempTraq thermometer-Time 3 | Skin surface temperature readings measured in Celsius using Temp Traq vs measured by Temp Traq and by Pulmonary artery catheter core thermister | 4 hours post baseline | |
Primary | Accuracy and precision of TempTraq thermometer-Time 4 | Skin surface temperature readings measured in Celsius using Temp Traq vs measured by Temp Traq and by Pulmonary artery catheter core thermister | 6 hours post baseline |
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