Safety and Feasibility of Prima-Temp Thermometer Patch
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| First Received Date ICMJE | March 1, 2012 | ||||||||
| Last Updated Date | August 21, 2012 | ||||||||
| Start Date ICMJE | February 2012 | ||||||||
| Estimated Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01587014 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Safety and Feasibility of Prima-Temp Thermometer Patch | ||||||||
| Official Title ICMJE | Safety and Feasibility of Prima-Temp Thermometer Patch in Determining Baseline Temperatures of Research Subjects in a Hospital Intensive Care Unit (ICU) | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients in hospital intensive care unit (ICU). |
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| Condition ICMJE | Fever | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | ICU patients | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 30 | ||||||||
| Estimated Completion Date | October 2012 | ||||||||
| Estimated Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01587014 | ||||||||
| Other Study ID Numbers ICMJE | 1-001 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Julie Dunn, M.D., Poudre Valley Health System | ||||||||
| Study Sponsor ICMJE | Poudre Valley Health System | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Poudre Valley Health System | ||||||||
| Verification Date | August 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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