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Somnotouch-NIBP Compared to Standard Ambulatory 24 Hours Blood Pressure Measurement (VAST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03054688
Recruitment Status : Completed
First Posted : February 15, 2017
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Study Description
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Brief Summary:
Comparison of 24 hours blood pressure measurement with puls-transit time versus cuffs.

Condition or disease Intervention/treatment Phase
Blood Pressure Device: Somnotouch NIBP Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Somnotouch-NIBP Compared to Standard Ambulatory 24 Hours Blood Pressure Measurement
Actual Study Start Date : April 25, 2017
Actual Primary Completion Date : March 1, 2018
Actual Study Completion Date : April 1, 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: Somnotouch NIBP
Blood pressure measurement with Somnotouch-NIBP device in addition to standard cuff based device
 Device: Somnotouch NIBP
Somnotouch NIBP in addition to standard blood pressure measurement


Outcome Measures
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Primary Outcome Measures :
  1. Difference in mean 24h systolic blood pressure [ Time Frame: 24 hours ]
    Difference in mean 24h systolic blood pressure


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Able to give informed consent

Exclusion Criteria:

  • Atrial fibrillation
  • Medical reasons why blood pressure measurement is not possible at the upper extremity (Shunt, Lymphedema)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054688


Locations
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Switzerland
University Hospital Basel
Basel, Basel City, Switzerland, 4051
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Thilo Burkard, MD University Hospital, Basel, Switzerland
Principal Investigator: Philipp Krisai, MD University Hospital, Basel, Switzerland
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03054688    
Other Study ID Numbers: 03061989
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No