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

• ClinicalTrials.gov Identifier: NCT01587014
• Recruitment Status: Completed
• First Posted: April 27, 2012
• Results First Posted: April 21, 2014
• Last Update Posted: February 20, 2017
• Sponsor: Poudre Valley Health System
• Information provided by (Responsible Party): Julie Dunn, M.D., Poudre Valley Health System

Study Description

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.

Condition or disease
Erythema; Edema; Papules White; Eruption

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 Design

• Study Type: Observational
• Actual Enrollment: 26 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Safety and Feasibility of Prima-Temp Thermometer Patch in Determining Baseline Temperatures of Research Subjects in a Hospital Intensive Care Unit (ICU)
• Study Start Date: February 2012
• Actual Primary Completion Date: December 2012
• Actual Study Completion Date: December 2012

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Total Number of Adverse Events Experienced by Participants Between Day 0 and Day 14 After Receiving the Prima-Temp Temparature Patch [ Time Frame: 0-14 days ]
   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.

Secondary Outcome Measures :

1. Determine Research Subject's Baseline Temperature. [ Time Frame: 0-14 days ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients in hospital intensive care unit (ICU).

Criteria

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).

Contacts and Locations

Locations

United States, Colorado

Medical Center of the Rockies

Loveland, Colorado, United States, 80538

Sponsors and Collaborators

Poudre Valley Health System

Investigators

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

More Information

Additional Information:

Research Site Website 

• Responsible Party: Julie Dunn, M.D., Principal Investigator, Poudre Valley Health System
• ClinicalTrials.gov Identifier: NCT01587014
• Other Study ID Numbers: 1-001
• First Posted: April 27, 2012
• Results First Posted: April 21, 2014
• Last Update Posted: February 20, 2017
• Last Verified: January 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Erythema; Skin Diseases; Skin Manifestations