Clinical trial NCT01587014: Safety and Feasibility of Prima-Temp Thermometer Patch
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erythema
Edema
Papules White
Eruption
Lead sponsor: Poudre Valley Health System
Sponsor class: OTHER
First posted: 2012-04-27
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in hospital intensive care unit (ICU).

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.

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.

Eligibility 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).

Primary outcomes:
measure: Total Number of Adverse Events Experienced by Participants Between Day 0 and Day 14 After Receiving the Prima-Temp Temparature Patch
timeFrame: 0-14 days
Secondary outcomes:
measure: Determine Research Subject's Baseline Temperature.
timeFrame: 0-14 days
Other outcomes:
Locations:
city: Loveland
country: United States
facility: Medical Center of the Rockies
state: Colorado
Study officials:
affiliation: Poudre Valley Health System
name: Julie Dunn, M.D.
role: PRINCIPAL_INVESTIGATOR
References: