Trial Outcomes & Findings for Safety and Feasibility of Prima-Temp Thermometer Patch (NCT NCT01587014)

NCT ID: NCT01587014

Last Updated: 2017-02-20

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 26 participants
• Primary outcome timeframe: 0-14 days
• Results posted on: 2017-02-20

Participant Flow

Participant milestones

Measure	Prima-Temp Monitoring Patch ICU patients receive the Prima-Temp Temperature Monitoring Patch.
Overall Study STARTED	26
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Prima-Temp Monitoring Patch ICU patients receive the Prima-Temp Temperature Monitoring Patch.
Overall Study Death	2

Baseline Characteristics

Safety and Feasibility of Prima-Temp Thermometer Patch

Baseline characteristics by cohort

Measure	Device Arm n=26 Participants ICU patients receive the Prima-Temp Temperature Monitoring Patch.
Age, Continuous	56 years n=5 Participants
Gender Female	9 Participants n=5 Participants
Gender Male	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Device Arm n=26 Participants ICU patients receive the Prima-Temp Temperature Monitoring Patch.
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 outcome

Timeframe: 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.

Outcome measures

Measure	Device Arm n=26 Participants ICU patients receive the Prima-Temp Temperature Monitoring Patch.
Determine Research Subject's Baseline Temperature.	0 data unavailable

Adverse Events

Device Arm

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Device Arm n=26 participants at risk ICU patients receive the Prima-Temp Temperature Monitoring Patch.
Skin and subcutaneous tissue disorders Erythema	3.8% 1/26 • Number of events 1 • Every 24 hours until patient was discharged from hospital, an average of 1 week Adverse events were recorded every 24 hours.

Additional Information

Dr. Julie Dunn

Medical Center of the Rockies

Phone: 970-624-1680

Email: julie.dunn@uchealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place