Safety and Feasibility of Prima-Temp Thermometer Patch (Prima-Temp)
3. januar 2017 opdateret af: Julie Dunn, M.D., Poudre Valley Health System
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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
26
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Colorado
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Loveland, Colorado, Forenede Stater, 80538
- Medical Center of the Rockies
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients in hospital intensive care unit (ICU).
Beskrivelse
Inclusion Criteria
- 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
Exclusion Criteria
- 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).
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Total Number of Adverse Events Experienced by Participants Between Day 0 and Day 14 After Receiving the Prima-Temp Temparature Patch
Tidsramme: 0-14 days
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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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0-14 days
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Determine Research Subject's Baseline Temperature.
Tidsramme: 0-14 days
|
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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0-14 days
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Julie Dunn, M.D., Poudre Valley Health System
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2012
Primær færdiggørelse (Faktiske)
1. december 2012
Studieafslutning (Faktiske)
1. december 2012
Datoer for studieregistrering
Først indsendt
1. marts 2012
Først indsendt, der opfyldte QC-kriterier
26. april 2012
Først opslået (Skøn)
27. april 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. februar 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. januar 2017
Sidst verificeret
1. januar 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1-001
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .