Ignite Creation Date:
2024-05-06 @ 12:29 AM
Last Modification Date:
2024-10-26 @ 10:50 AM
Study NCT ID:
NCT01587014
Status:
COMPLETED
Last Update Posted:
2017-02-20
First Post:
2012-03-01
Brief Title:
Safety and Feasibility of Prima-Temp Thermometer Patch
Sponsor:
Poudre Valley Health System
Organization:
Poudre Valley Health System
Study Overview
Official Title:
Safety and Feasibility of Prima-Temp Thermometer Patch in Determining Baseline Temperatures of Research Subjects in a Hospital Intensive Care Unit ICU
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Prima-Temp
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 subjects baseline temperature with temperatures taken in the ICU in the normal course of care
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 subjects 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 patients individual baseline temperature to provide individualized guidelines for medical interventions with an increase of 2F above baseline as documentation of a fever Finally the frequent temperature monitoring should be minimally invasive and comfortable to the patient
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None