Safety and Feasibility of Prima-Temp Thermometer Patch

Edema Clinical Trial

— Prima-Temp  

Official title:

Safety and Feasibility of Prima-Temp Thermometer Patch in Determining Baseline Temperatures of Research Subjects in a Hospital Intensive Care Unit (ICU)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01587014
• Other study ID #: 1-001
• Status: Completed
• Phase: N/A
• First received: March 1, 2012
• Last updated: March 17, 2014
• Start date: February 2012
• Est. completion date: December 2012

Study information

• Verified date: February 2014
• Source: Poudre Valley Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Edema
• Erythema
• Vesicular Eruption
• Vesicular Papules

Locations

Country	Name	City	State
United States	Medical Center of the Rockies	Loveland	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Poudre Valley Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess Safety of the Prima-Temp Temperature Patch With Nursing Staff Skin Site Assessments.	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.	0-14 days	Yes
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.	0-14 days	No

External Links

•   Research Site Website