Safety and Feasibility of Prima-Temp Thermometer Patch

This study is currently recruiting participants.
Verified August 2012 by Poudre Valley Health System
Sponsor:
Information provided by (Responsible Party):
Julie Dunn, M.D., Poudre Valley Health System
ClinicalTrials.gov Identifier:
NCT01587014
First received: March 1, 2012
Last updated: August 21, 2012
Last verified: August 2012

March 1, 2012
August 21, 2012
February 2012
October 2012   (final data collection date for primary outcome measure)
Assess safety of the Prima-Temp temperature patch with nursing staff skin site assessments. [ Time Frame: 24 hours. ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01587014 on ClinicalTrials.gov Archive Site
Determine research subject's baseline temperature. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Safety and Feasibility of Prima-Temp Thermometer Patch
Safety and Feasibility of Prima-Temp Thermometer Patch in Determining Baseline Temperatures of Research Subjects in a Hospital Intensive Care Unit (ICU)

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients in hospital intensive care unit (ICU).

Fever
Not Provided
ICU patients
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
October 2012
October 2012   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact: Julie Dunn, M.D. 970.624.1689 dunnju@pvhs.org
Contact: Melanie Roberts, R.N. 970.624.2154 mgr@pvhs.org
United States
 
NCT01587014
1-001
No
Julie Dunn, M.D., Poudre Valley Health System
Poudre Valley Health System
Not Provided
Principal Investigator: Julie Dunn, M.D. Poudre Valley Health System
Poudre Valley Health System
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP