- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01546285
B40 Non-Invasive Blood Pressure Equivalency Study
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Automated non-invasive blood pressure devices have a long history. These devices first made their appearance in the mid-1970's. Since that time, there have been many improvements in the performance of these devices. Specifically, when making changes to the algorithms that control these devices, the goals are: to improve accuracy and precision in the blood pressure (BP) estimates, to reduce the time needed to determine the BP estimates, to increase comfort for the patient, and to work through artifacts and arrhythmias that are often present in the clinical environment.
The purpose of this study is to demonstrate equivalency of the GE Healthcare B40 Patient Monitor noninvasive blood pressure (NIBP) parameter compared to the reference device.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Colorado
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Louisville, Colorado, Forenede Stater, 80027
- Clinimark
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Ability to provide written informed consent or have a legally authorized representative including a parent or guardian provide written informed consent
- Within the age range from older than 3 years old to 75 years old (adult and child)
- Ability to maintain proper placement of cuff and/or probe and/or sensor
Exclusion Criteria:
- Neonates (ages 0-29 days) and infants (30 days to 3 years old) shall be excluded
- Any subject deemed too unstable, by clinician's discretion, or for another reason deemed unacceptable for study by the clinician
- Known dysrhythmias (when applicable)
- Known disease state that compromises circulation to the extremity
- Vigorous exercise prior to participating in the study
- Excessive movement or excitability causing false values or no determinations
- Known allergy to latex when latex products will be in contact with subject
- Pregnant females
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Blood Pressure Reading
Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings
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Simultaneous blood pressure reading on the Investigational B40 patient monitor and DINAMAP PRO1000 patient monitor
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Difference Between the B40 Monitor and Reference Device DINAMAP PRO1000 on NIBP Measurements
Tidsramme: End of each blood pressure reading
|
The primary endpoints are the difference in systolic, diastolic and mean blood pressure values between the B40 Monitor and PRO1000.
The mean of the difference should be no more than 5mmHg and the standard deviation of the difference should be no more than 8mmHg per the AAMI SP-10 standard.
|
End of each blood pressure reading
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 118.04-2011-GES-0002
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