N/A
N=26
Safety and Feasibility of Prima-Temp Thermometer Patch
Erythema · Edema · Papules White · Eruption
Bottom Line
View on ClinicalTrials.gov: NCT01587014 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: Total Number of Adverse Events Experienced by Participants Between Day 0 and Day 14 After Receiving the Prima-Temp Temparature Patch — 1 Adverse event
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Poudre Valley Health System
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Adverse Events Experienced by Participants Between Day 0 and Day 14 After Receiving the Prima-Temp Temparature Patch |
1 | — |
| SECONDARY Determine Research Subject's Baseline Temperature. |
— | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Men and women of any race.
- Men of age > 18 years
- Women with no childbearing potential (age > 50, age ≥ 18 s/p hysterectomy)
- Arm circumference >23 cm and < 38 cm
Exclusion Criteria
- Patient with known or documented adhesive, Tegaderm allergies.
- Abnormal axillary integument such as rashes, burns, laceration.
- Hidradenitis suppurativa and/or dermatologic diseases that might interfere with the evaluation of the test site reactions.
- Non-English speakers
- Pregnant women
- Patient requiring hypothermic therapy, with the exception of non-steroidal anti-inflammatory treatment (acetaminophen, ibuprofen, aspirin, etc).
Data sourced from ClinicalTrials.gov (NCT01587014). 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.