ErythemaPrima-TempNCT01587014
Safety and Feasibility of Prima-Temp Thermometer Patch
An observational study of Erythema and Edema, run by Poudre Valley Health System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Erythema, Edema, Papules White
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Dec 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in hospital intensive care unit (ICU).
Who may be able to join
- Men and women of any race.
- Men of age > 18 years
- Women with no childbearing potential (age > 50, age ≥ 18 s/p hysterectomy)
- Arm circumference >23 cm and < 38 cm
Who cannot join
- Patient with known or documented adhesive, Tegaderm allergies.
- Abnormal axillary integument such as rashes, burns, laceration.
- Hidradenitis suppurativa and/or dermatologic diseases that might interfere with the evaluation of the test site reactions.
- Non-English speakers
- Pregnant women
- Patient requiring hypothermic therapy, with the exception of non-steroidal anti-inflammatory treatment (acetaminophen, ibuprofen, aspirin, etc).
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical Center of the Rockies
Loveland, Colorado, 80538
About this study
Official title: 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.
Read the 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.
- Conditions
- Erythema, Edema, Papules White, Eruption
- Medical subject headings
- Erythema, Edema, Exanthema
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Adverse Events Experienced by Participants Between Day 0 and Day 14 After Receiving the Prima-Temp Temparature Patch
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.
Measured: 0-14 days
Secondary outcomes (1)
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.
Measured: 0-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ErythemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poudre Valley Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Dunn, M.D., Poudre Valley Health System
- Investigators
- Julie Dunn, M.D., Principal investigator, Poudre Valley Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587014
- Sponsor's protocol ID
- 1-001
- Acronym
- Prima-Temp
- Status last verified
- Jan 2017
- First submitted
- 1 Mar 2012
- Last updated
- 20 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Prima-Temp Thermometer Patch in Determining Baseline Temperatures of Research Subjects in a Hospital Intensive Care Unit (ICU)
- ClinicalTrials.gov ID
- NCT01587014
- Acronym / sponsor ID
- Prima-Temp / 1-001
- Conditions
- Erythema, Edema, Papules White, Eruption
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Poudre Valley Health SystemUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 Apr 2012 (estimated)
- Results
- Posted 21 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in hospital intensive care unit (ICU).
Key inclusion criteria (4 listed)
- Men and women of any race.
- Men of age > 18 years
- Women with no childbearing potential (age > 50, age ≥ 18 s/p hysterectomy)
- Arm circumference >23 cm and < 38 cm
Key exclusion criteria (6 listed)
- Patient with known or documented adhesive, Tegaderm allergies.
- Abnormal axillary integument such as rashes, burns, laceration.
- Hidradenitis suppurativa and/or dermatologic diseases that might interfere with the evaluation of the test site reactions.
- Non-English speakers
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total Number of Adverse Events Experienced by Participants Between Day 0 and Day 14 After Receiving the Prima-Temp Temparature Patch
Time frame: 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.
1 secondary outcome
Determine Research Subject's Baseline Temperature.
Time frame: 0-14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Research Site WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Dunn, M.D. principal investigator
Poudre Valley Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erythema and Edema, run by Poudre Valley Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Number of Adverse Events Experienced by Participants Between Day 0 and Day 14 After Receiving the Prima-Temp Temparature Patch (time frame: 0-14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2017.