Wearable Blood-Pressure Monitoring Comparison Study (WBPMCS)
22. juli 2026 opdateret af: Moritz Herzog, Technische Universität Dresden
Wearable Blood-Pressure Monitoring Comparison Study (WBPMCS)
The goal of this clinical trial is to compare the accuracy, clinical applicability, and usability of different wearable blood pressure monitoring methods integrated in wearable devices, such as smartwatches, in hospitalized patients. The study evaluates novel photoplethysmography (PPG)-based and wrist-oscillometric blood pressure measurement methods against established clinical reference methods (upper-arm cuff measurements on the general ward and invasive arterial blood pressure monitoring (A-line) in the intensive care unit).
The main questions the study aims to answer are:
- Can novel blood pressure monitoring methods suitable for integration into wearable devices achieve clinically acceptable agreement with established reference measurements?
- How does the performance of calibration-dependent wearable devices change over time following calibration?
- How does the performance of the investigated methods compare with each other?
- How do the investigated methods perform for patients with different pre-existing conditions ?
To answer these questions, participants will undergo:
- blood pressure measurements using different wearable devices based on PPG and wrist oscillometry
- standardized reference blood pressure measurements using an upper-arm cuff (general ward) or an existing invasive arterial line (intensive care unit)
- repeated measurements over three consecutive days on the general ward to assess calibration stability and measurement reproducibility,
Studieoversigt
Status
Ikke rekrutterer endnu
Undersøgelsestype
Observationel
Tilmelding (Anslået)
120
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Moritz Herzog, MD
- Telefonnummer: 0049 351 458 11501
- E-mail: moritz.herzog@ukdd.de
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
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Hospitalized adult patients aged 21 to 85 years who are treated on participating general wards or intensive care units at the hospital and are able to provide written informed consent.
Beskrivelse
Inclusion Criteria:
- Blood pressure measurements can be performed on at least one arm, for example no amputation, dialysis shunt, or obstructive dressing
- Ability to understand the study information and provide written informed consent
- For participants in the intensive care unit: an arterial line placed for clinical reasons
Exclusion Criteria:
- Wrist circumference exceeds the size range of the investigated wearable devices
- Physical or medical conditions preventing placement of the wearable devices, including relevant skin lesions, wounds, severe edema, or patient restraint
- Inability to provide written informed consent
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Cohort at general ward
|
|
Cohort at ICU
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Agreement of wearable blood pressure measurement methods with clinical reference measurements
Tidsramme: General ward: At each measurement session on study days 1, 2, and 3. ICU: At measurement session on study day 1, approx. 2 hours after device calibration
|
The mean difference and standard deviation of the differences in systolic and diastolic blood pressure, expressed in mmHg, between each investigated wearable blood pressure measurement method and the corresponding reference method.
|
General ward: At each measurement session on study days 1, 2, and 3. ICU: At measurement session on study day 1, approx. 2 hours after device calibration
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
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 (Anslået)
20. juli 2026
Primær færdiggørelse (Anslået)
31. juli 2027
Studieafslutning (Anslået)
31. december 2027
Datoer for studieregistrering
Først indsendt
18. juli 2026
Først indsendt, der opfyldte QC-kriterier
18. juli 2026
Først opslået (Faktiske)
22. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BO ff (Mono)-EK-475112025
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
We plan to provide the anonymized IPD after publication.
IPD-delingstidsramme
after finishing the study, data will be stored locally for at least 10 years
IPD-delingsadgangskriterier
contact the investigators via mail
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
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 .
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