Clinical Study of Wrist Blood Pressure Monitor in Conformance With the ANSI/AAMI SP10 Standard (WristBPM01)

August 8, 2012 updated by: Leo Wang

Verify Wrist BPM TMB-1117 to Comply With ANSI/AAMI SP10

The clinical protocol of the clinical testing of this device:

  1. Objective of the test: To verify the efficiency of device.
  2. Test methods and procedures: Clinical test in two positions: Seated and Supine.
  3. DUT: Transtek Wrist Blood Pressure Monitor, Model: TMB-1117. Cuff size: 13.5 - 21.5 cm.
  4. Comparison device: Yuyue Medical Blood Pressure Meter, YYBP-212, accuracy: ±1 mmHg and range: 0-300 mmHg.
  5. Study endpoints: Comply with ANSI/AAMI SP10-2002 standard.
  6. Statistical methodology used: Description of statistical methods.
  7. Result: Meet the requirements of SP10.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hospital Information

Hospital Information The data was collected by Zhongshan City People's Hospital Clinical Investigator Team at Zhongshan City People's Hospital, No.2 Sunwen Dong Road, Zhongshan, Guangdong 528403, P. R. China.

Investigator: Dr. Cao Yuedong, Leader; Li Qidong, Nurse A; Chen Wenqian, Nurse B.

Contact Dr. Cao Yuedong Tel: +86 760 88823818

Used Equipments DUT (Device Under Test): Transtek Wrist Blood Pressure Monitor, TMB-1117 Reference Device: Yuyue Medical Blood Pressure Meter, YYBP-212, accuracy: ±1 mmHg and range: 0-300 mmHg.

Test Protocol

  1. Test Purpose:

    The aim of clinical test is to determine, for the purpose of design qualification, the overall performance of the system meeting the following requirement: For systolic and diastolic pressures, treated separately, the mean difference of the paired measurement of the test system and the comparison system shall be ± 5 mmHg or less, with standard deviation of 8 mmHg or less.

  2. Target Subject:

1) The subject database shall contain at least 85 subjects. 2) The distribution of blood pressure of the subjects required to be: At least 10 percent below 100 mmHg systolic; at least 10 percent above 160 mmHg systolic; at least 10 percent below 60 mmHg diastolic; at least 10 percent above 100 mmHg diastolic; with the remainder distributed between these outer limits.

3. Identification and precision of equipment used According to ANSI/AAMI SP10, the maximum measurement error of the non-automatic sphygmomanometers used in the comparing test shall not exceed 1.0mmHg at the temperature of the test. The manometer was used to verify its accuracy before test.

The clinical study was conducted according to the protocol described in the ANSI/AAMI SP10 with 85 subjects.

4. Test procedures (auscultatory method, same-limb sequential measurement was chosen)

  1. Record the age, gender, and circumference of the left wrist of the subject.
  2. Let subject seated or supine calmly for five minutes before test.
  3. Measure heart rate in one minute by palpation on radial artery, record it.
  4. Two observers shall make simultaneous, blinded, blood pressure determination on the subject's left arm. Each nurse will write down the reading on a small piece of paper, make a tick if there is an auscultatory gap and then submit to the recorder.
  5. The two readings separately from two observers will be recorded, and if two observers agree that they find an auscultatory gap this time, it will also be recorded. The wrist cuff will be take off, after 90 seconds rest, TMB-1117 cuff will be taken on and tested, and the readings (systolic, diastolic, mean BP and Heart rate) be recorded.
  6. For each subject, repeat 3) and 5) to get 3 measurements.
  7. Repeat step 1) to 6) for every subject.

5. Note:

  1. No motion and speaking are allowed during the measurement.
  2. The reference device's cuff release at the rate about 3 mmHg/s so to ensure an accurate reading of observer.
  3. The arm, wrist and the haear of subject to keep on the same height when measurement.
  4. Test environment: Temperature: 20±1 ℃; Relative humidity: 40~50%.

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Zhongshan, Guangdong, China, 528403
        • Zhongshan City People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • male,female,

Exclusion Criteria:

  • below 18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DUT Arm

DUT: Transtek Wrist Blood Pressure Monitor TMB-1117

Measurement: Blood Pressure

Groups/Cohorts: DUT
Device: Blood pressure Transtek Wrist Blood Pressure Monitor, TMB-1117
Systolic, Diastolic pressure.
Other Names:
  • DUT TMB-1117 measurement
Experimental: Reference Arm

Reference Device: Yuyue Medical Blood Pressure Meter, YYBP-212, accuracy: ±1mmHg and range: 0-300mmHg.

Measurement: Blood Pressure

Groups/Cohorts: Reference
Device: Blood pressure Reference Device: Yuyue Medical Blood Pressure Meter, YYBP-2
Systolic, Diastolic pressure
Other Names:
  • Reference mercury sphygmomanometer measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Verify the accuracy of measure functions of device
Time Frame: 10 days
Verify the accuracy of device if meet the requirements of ANSI/AAMI SP10 when it measure Systolic & Diastolic blood pressure.
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leo Wang

Collaborators

BTS International

Investigators

  • Study Chair: Leo Wang, Leader, BTS International

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

August 1, 2012

First Submitted That Met QC Criteria

August 8, 2012

First Posted (Estimate)

August 13, 2012

Study Record Updates

Last Update Posted (Estimate)

August 13, 2012

Last Update Submitted That Met QC Criteria

August 8, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Wrist BPM TMB-1117
  • BTS-TRANS12001 (Other Identifier: BTSInternational)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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