Edema, Eruption, Erythema, Papules White
Conditions
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.
Interventions
None listed
Sponsors
Poudre Valley Health System
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Adverse Events Experienced by Participants Between Day 0 and Day 14 After Receiving the Prima-Temp Temparature Patch | 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
| Measure | Time frame | Description |
|---|---|---|
| Determine Research Subject's Baseline Temperature. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Device Arm ICU patients receive the Prima-Temp Temperature Monitoring Patch. | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
Baseline characteristics
| Characteristic | Device Arm |
|---|---|
| Age, Continuous | 56 years |
| Gender Female | 9 Participants |
| Gender Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 26 |
| serious Total, serious adverse events | 0 / 26 |
Outcome results
Primary
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.
Time frame: 0-14 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Device Arm | Total Number of Adverse Events Experienced by Participants Between Day 0 and Day 14 After Receiving the Prima-Temp Temparature Patch | 1 Adverse event |
Secondary
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.
Time frame: 0-14 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Device Arm | Determine Research Subject's Baseline Temperature. | 0 data unavailable |