- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03795831
Validation Study in Patients of a Non-invasive Blood Pressure Monitor for Perioperative Use
Collecting all available data (waveforms, beat to beat data, status data) generated by a non invasive blood pressure monitor on each hand and compare this to the actual data obtained by intra arterial (radial) monitoring.
This to see if the non invasive bloodpressure monitor can be validated for intraoperative use.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Although a blood pressure monitoring device could be evaluated by the comparing systolic, diastolic and mean arterial pressure to a reference pressure, it is the specific aim to collect all available data (waveforms, beat to beat data, status data) generated by the blood pressure monitor.
After data analysis and comparison to patient's actual intra-arterial waveform, the outcome will be evaluated by Association for the Advancement of Medical Instrumentation (AAMI) standards to see if the non invasive bloodpressure monitor can be validated for intraoperative use.
The study is targeted at patients already monitored with a system that accurately measures and stores the intra-arterial waveform, such as the FloTrac system in the EV1000 monitor.
This study is a substudy of a feasability protocol evaluating a new algorithm for the Clearsight system.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Amsterdam, Holland, 1105AZ
- Rekruttering
- Academic Medical Center
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Kontakt:
- D.P. Veelo, Dr.
- Telefonnummer: 0031205662533
- E-mail: d.p.veelo@amc.uva.nl
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Patients whose arterial blood pressure is measured invasively with technology that allows for the storage of the intra-arterial waveform with sufficient quality and resolution (Flotrac).
- Patients older than 18, for elective general surgery.
Exclusion Criteria:
- Patient conditions that are expected to potentially and significantly affect the transfer of pressure between radial artery and the finger, e.g. due to recent finger fractures
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Cohort
Adult patients, undergoing surgery requiring general anesthesia, planned to be monitored with a system that accurately measures and stores the intra-arterial waveform.
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A cuff is placed on a finger of the patient.
The ClearSight system uses a volume clamp technology allowing measuring of continuous blood pressure waveform.
Note: There will only be observational recordings, no interventions
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
validation systole, diastole, mean ABP and pulse pressure
Tidsramme: within 1 hour
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accuracy and precision of invasive blood pressure curve vs non-invasive blood pressure curves(ipsilateral and contralateral)
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within 1 hour
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implementation of software alterations to improve systole, diastole, mean ABP accuracy and pulse pressure
Tidsramme: time during surgery
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Comparison of the non-invasive blood pressure curve after software alterations to the reference and invasive arterial blood pressure curve
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time during surgery
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: D.P. Veelo, Dr, inverstigator
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2017-14
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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