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

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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

Tracking Information
First Submitted Date  ICMJE February 13, 2017
First Posted Date  ICMJE February 15, 2017
Last Update Posted Date June 15, 2018
Actual Study Start Date  ICMJE April 25, 2017
Actual Primary Completion Date March 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2017)
Difference in mean 24h systolic blood pressure [ Time Frame: 24 hours ]
Difference in mean 24h systolic blood pressure
Original Primary Outcome Measures  ICMJE
 (submitted: February 13, 2017)
Difference in mean 24h systolic blood pressure [ Time Frame: 24 hours ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Somnotouch-NIBP Compared to Standard Ambulatory 24 Hours Blood Pressure Measurement
Official Title  ICMJE Somnotouch-NIBP Compared to Standard Ambulatory 24 Hours Blood Pressure Measurement
Brief Summary Comparison of 24 hours blood pressure measurement with puls-transit time versus cuffs.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Blood Pressure
Intervention  ICMJE Device: Somnotouch NIBP
Somnotouch NIBP in addition to standard blood pressure measurement
Study Arms  ICMJE Experimental: Somnotouch NIBP
Blood pressure measurement with Somnotouch-NIBP device in addition to standard cuff based device
Intervention: Device: Somnotouch NIBP
Publications * Krisai P, Vischer AS, Kilian L, Meienberg A, Mayr M, Burkard T. Accuracy of 24-hour ambulatory blood pressure monitoring by a novel cuffless device in clinical practice. Heart. 2019 Mar;105(5):399-405. doi: 10.1136/heartjnl-2018-313592. Epub 2018 Sep 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 13, 2018)
83
Original Estimated Enrollment  ICMJE
 (submitted: February 13, 2017)
50
Actual Study Completion Date  ICMJE April 1, 2018
Actual Primary Completion Date March 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03054688
Other Study ID Numbers  ICMJE 03061989
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Basel, Switzerland
Study Sponsor  ICMJE University Hospital, Basel, Switzerland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thilo Burkard, MD University Hospital, Basel, Switzerland
Principal Investigator: Philipp Krisai, MD University Hospital, Basel, Switzerland
PRS Account University Hospital, Basel, Switzerland
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP