Safety and Feasibility of Prima-Temp Thermometer Patch
Study Details
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 | Intervention/Treatment | Phase |
|---|---|---|
|
|
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
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria
-
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
Exclusion Criteria
-
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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 1-001
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Prima-Temp Monitoring Patch |
|---|---|
| Arm/Group Description | ICU patients receive the Prima-Temp Temperature Monitoring Patch. |
| Period Title: Overall Study | |
| STARTED | 26 |
| COMPLETED | 24 |
| NOT COMPLETED | 2 |
Baseline Characteristics
| Arm/Group Title | Device Arm |
|---|---|
| Arm/Group Description | ICU patients receive the Prima-Temp Temperature Monitoring Patch. |
| Overall Participants | 26 |
| Age (years) [Median (Full Range) ] | |
| Median (Full Range) [years] |
56
|
| Gender (Count of Participants) | |
| Female |
9
34.6%
|
| Male |
17
65.4%
|
Outcome Measures
| Title | Total Number of Adverse Events Experienced by Participants Between Day 0 and Day 14 After Receiving the Prima-Temp Temparature Patch |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Device Arm |
|---|---|
| Arm/Group Description | ICU patients receive the Prima-Temp Temperature Monitoring Patch. |
| Measure Participants | 26 |
| Number [Adverse event] |
1
|
| Title | Determine Research Subject's Baseline Temperature. |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Device Arm |
|---|---|
| Arm/Group Description | ICU patients receive the Prima-Temp Temperature Monitoring Patch. |
| Measure Participants | 26 |
| Number [data unavailable] |
0
|
Adverse Events
| Time Frame | Every 24 hours until patient was discharged from hospital, an average of 1 week | |
|---|---|---|
| Adverse Event Reporting Description | Adverse events were recorded every 24 hours. | |
| Arm/Group Title | Device Arm | |
| Arm/Group Description | ICU patients receive the Prima-Temp Temperature Monitoring Patch. | |
All Cause Mortality |
||
| Device Arm | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Device Arm | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/26 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Device Arm | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/26 (3.8%) | |
| Skin and subcutaneous tissue disorders | ||
| Erythema | 1/26 (3.8%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Julie Dunn |
|---|---|
| Organization | Medical Center of the Rockies |
| Phone | 970-624-1680 |
| julie.dunn@uchealth.org |
- 1-001