Safety and Feasibility of Prima-Temp Thermometer Patch

NCT01587014 | Completed Results

• 1 other identifier: 1-001
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Erythema; Edema; Papules White; Eruption

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Determine Research Subject's Baseline Temperature.

  0-14 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in hospital intensive care unit (ICU).

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Poudre Valley Health System: lead

Study Sites (1)

Medical Center of the Rockies

Loveland, Colorado, 80538, United States

Location

Related Links

• Research Site Website

MeSH Terms

Conditions

Erythema; Edema; Exanthema

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Julie Dunn
• Organization: Medical Center of the Rockies

julie.dunn@uchealth.org

970-624-1680

Study Officials

• Julie Dunn, M.D.

  Poudre Valley Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 1, 2012
• First Posted: April 27, 2012
• Study Start: February 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 20, 2017
• Results First Posted: April 21, 2014

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)