NCT01587014|CompletedResults
Safety and Feasibility of Prima-Temp Thermometer Patch
Prima-Temp
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Prima-Temp
Sponsor study identifier
observational
26
1 country
1
Study Start
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2012
Actual (reported)Study Completion
December 2012
Actual (reported)The purpose of this study is to test the safety and feasibility of the Prima-Temp Thermometer Patch in determining baseline temperatures of research subjects in a hospital intensive care unit (ICU). Primary Objective: Assess safety of the Prima-Temp temperature patch with nursing staff skin site assessments. Secondary Objective: Establish individual subject baseline temperature using intermittent temperature measurements (every 5 minutes) with the Prima-Temp thermometer patch and wireless transmission of the data to a receiver box and HIPAA compliant, centrally located personal computer (PC) and compare research subject's baseline temperature with temperatures taken in the ICU in the normal course of care.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2012
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
March 1, 2012
Actual (reported)April 27, 2012
Actual (reported)December 2012
Actual (reported)December 2012
Actual (reported)April 21, 2014
Actual (reported)Total Number of Adverse Events Experienced by Participants Between Day 0 and Day 14 After Receiving the Prima-Temp Temparature Patch
The nursing staff will complete a thermometer skin site assessment daily. If the patch is removed or dislodged prior to study day 7 and 14 data points for any reason other than temporary transfer from the floor for a medical study, the nursing staff will be asked to complete an additional comfort skin site assessment. The area evaluated by the nurse will include skin in contact with both the Covidien/Kendall Lifetrace® belt and the thermometer patch.
0-14 days
Determine Research Subject's Baseline Temperature.
0-14 days
Patients in hospital intensive care unit (ICU).
Medical Center of the Rockies
Loveland, Colorado, 80538, United States
Julie Dunn, M.D.
Poudre Valley Health System
26 participants (actual enrollment reported by the registry).
First Submitted
March 1, 2012
First Posted
April 27, 2012
Study Start
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
December 2012
Actual (reported)Study Completion
December 2012
Actual (reported)Last Updated
February 20, 2017
Results First Posted
April 21, 2014
Record last verified: 2017-01
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Source: ClinicalTrials.gov.
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