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Accuracy of Non-Invasive Blood Pressure Measurement in Adults (NIBP)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Sotera Wireless, Inc.
ClinicalTrials.gov Identifier:
NCT01183741
First received: August 13, 2010
Last updated: June 21, 2011
Last verified: June 2011
History of Changes
  Purpose

The purpose of this study is to compare the accuracy of the Sotera ViSi, an investigational device, to auscultation (measurement with a cuff) in determining systolic and diastolic blood pressure (BP) in adult subjects.


Condition Phase
Hypertension
Hypotension
 Phase 3

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Clinical Evaluation of the Sotera VisiTM System for Measurement of Systolic and Diastolic Blood Pressures in Adults

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sotera Wireless, Inc.:

Estimated Enrollment: 150
Study Start Date: September 2010
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Detailed Description:

This study is a single-center blinded study that will enroll approximately 150 adult subjects. Trained auscultators will perform the standard auscultation BP measurements. They will be blinded to each other's measurements and from the ViSi measurements.

The study population will be randomized into two groups based on the side of the blood pressure measurement: the left arm group (LAG) and the right arm group (RAG).

The randomization ratio of the LAG and RAG will be 1:1. There will be forced stratification in order to ensure that the study subjects meet the required arm circumference and blood pressure distributions as specified in the SP10:2008 and ISO 81060-2:2009(E) standards.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Eligible subjects are adults of any ethnic background who consent to spot-check blood pressure measurements and in whom paired blood pressure measurements with the ViSi will be feasible during a single visit. Subjects need to be greater than 12 years of age on the date of measurement and need to meet all the other inclusion and exclusion criteria.

Criteria

Inclusion Criteria:

  • Subject is greater than 12 years of age at the time of screening.
  • Subject's upper arm circumference is between 20cm and 55cm.
  • Subject is willing to undergo the Informed Consent process prior to enrollment in the study.
  • Subject is willing and able to participate for up to 60 minutes.

Exclusion Criteria:

  • Subject is participating in another clinical study that may interfere with the results of this study.
  • Subject is unable to have a blood pressure measurement taken from either arm for any reason.
  • Subject is evaluated by the Investigator and found to be medically unsuitable for participation in this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01183741

Locations
United States, California
Scripps Clinic Rancho Bernardo
San Diego, California, United States, 92128
Sponsors and Collaborators
Sotera Wireless, Inc.
Investigators
Principal Investigator: Margaret Drehobl, M.D. Scripps Health
  More Information

No publications provided

Responsible Party: Gary Manning, Vice President Clinical Affairs and Business Development, Sotera Wireless, Inc.
ClinicalTrials.gov Identifier: NCT01183741     History of Changes
Other Study ID Numbers: SOW-US10-003, 0-00026
Study First Received: August 13, 2010
Last Updated: June 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Sotera Wireless, Inc.:
Hypertension
Hypotension
Blood pressure

Additional relevant MeSH terms:
Hypertension
Hypotension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013