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Somnotouch-NIBP Compared to Standard Ambulatory 24-hours Blood Pressure Measurement

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Recruiting
CT.gov ID
NCT03975582
Collaborator
(none)
300
Enrollment
1
Location
34.9
Anticipated Duration (Months)
8.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Comparison of 24 hours blood pressure measurement with puls-transit time versus cuffs.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Somnotouch-NIBP Compared to Standard Ambulatory 24 Hours Blood Pressure Measurement - a Prospective Registry
    Actual Study Start Date :
    Jul 4, 2019
    Anticipated Primary Completion Date :
    Jun 1, 2022
    Anticipated Study Completion Date :
    Jun 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Difference in mean 24 hours systolic blood pressure [24 hours]

      Difference in mean 24 hours systolic blood pressure

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age ≥ 18 years

    • Ability to give informed consent

    Exclusion Criteria:

    • Age < 18 years

    • Medical reasons that forbid blood pressure measurements on upper extremities

    • Not able to give informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Basel Basel Basel Stadt Switzerland 4031

    Sponsors and Collaborators

    • University Hospital, Basel, Switzerland

    Investigators

    • Principal Investigator: Thilo Burkard, MD, University Hospital, Basel, Switzerland

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Basel, Switzerland
    ClinicalTrials.gov Identifier:
    NCT03975582
    Other Study ID Numbers:
    • VAST-Registry
    First Posted:
    Jun 5, 2019
    Last Update Posted:
    Nov 11, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Nov 11, 2021