Safety and Feasibility of Prima-Temp Thermometer Patch (Prima-Temp)

Safety and Feasibility of Prima-Temp Thermometer Patch in Determining Baseline Temperatures of Research Subjects in a Hospital Intensive Care Unit (ICU)

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.

Study Overview

• Status: Completed
• Conditions: Edema; Erythema; Eruption; Papules White

Detailed Description

The manifestation of fever and its characteristics is essential to the care of intensive care unit patients. As a marker for infection or other disease process, the presence of a fever and its temperature peak must be reliably obtained in ICU patients and must be monitored closely to optimize effective therapy. Inherent variability of different temperature measurement methods can lead to a difficulty in determining the optimal timing of medical interventions. Ideally, nurses and medical staff in acute care hospital facilities could have a temperature monitoring system that aids recognition of fever and systemic infection that is not labor intensive and provides consistent and reliable temperatures. Automatic transmission to a data recorder lessens the chances of manual entry error into the medical record. Frequent measurements allow establishment of a patient's individual baseline temperature to provide individualized guidelines for medical interventions with an increase of 2°F above baseline as documentation of a fever. Finally, the frequent temperature monitoring should be minimally invasive and comfortable to the patient.

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Loveland, Colorado, United States, 80538
      • Medical Center of the Rockies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients in hospital intensive care unit (ICU).

Description

Inclusion Criteria

1. Men and women of any race.
2. Men of age > 18 years
3. Women with no childbearing potential (age > 50, age ≥ 18 s/p hysterectomy)
4. Arm circumference >23 cm and < 38 cm

Exclusion Criteria

1. Patient with known or documented adhesive, Tegaderm allergies.
2. Abnormal axillary integument such as rashes, burns, laceration.
3. Hidradenitis suppurativa and/or dermatologic diseases that might interfere with the evaluation of the test site reactions.
4. Non-English speakers
5. Pregnant women
6. Patient requiring hypothermic therapy, with the exception of non-steroidal anti-inflammatory treatment (acetaminophen, ibuprofen, aspirin, etc).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine Research Subject's Baseline Temperature.	Using intermittent temperature data obtained with Prima-Temp temperature patch and wireless transmission to a receiver box and PC, researchers will compare research subject's baseline temperature with temperatures taken in the ICU in the normal course of care.	0-14 days

Collaborators and Investigators

• Sponsor: Poudre Valley Health System
• Investigators: Principal Investigator: Julie Dunn, M.D., Poudre Valley Health System

Publications and helpful links

Helpful Links

• Research Site Website

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: March 1, 2012
• First Submitted That Met QC Criteria: April 26, 2012
• First Posted (Estimate): April 27, 2012

Study Record Updates

• Last Update Posted (Actual): February 20, 2017
• Last Update Submitted That Met QC Criteria: January 3, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Erythema
• Other Study ID Numbers: 1-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO