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

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. Identifier: NCT01183741
Recruitment Status : Withdrawn
First Posted : August 18, 2010
Last Update Posted : June 22, 2011
Information provided by:
Sotera Wireless, Inc.

Brief Summary:
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 or disease
Hypertension Hypotension

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.

Study Type : Observational
Estimated Enrollment : 150 participants
Time Perspective: Prospective
Official Title: Clinical Evaluation of the Sotera VisiTM System for Measurement of Systolic and Diastolic Blood Pressures in Adults
Study Start Date : September 2010
Estimated Primary Completion Date : October 2010
Estimated Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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.

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.

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 identifier (NCT number): NCT01183741

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

Responsible Party: Gary Manning, Vice President Clinical Affairs and Business Development, Sotera Wireless, Inc. Identifier: NCT01183741     History of Changes
Other Study ID Numbers: SOW-US10-003
First Posted: August 18, 2010    Key Record Dates
Last Update Posted: June 22, 2011
Last Verified: June 2011

Keywords provided by Sotera Wireless, Inc.:
Blood pressure

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases