Clinical trial NCT01662947: Clinical Study of Wrist Blood Pressure Monitor in Conformance With the ANSI/AAMI SP10 Standard
Official title: Verify Wrist BPM TMB-1117 to Comply With ANSI/AAMI SP10
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Efficacy of Wrist BPM Measurement
Hypertension
Keywords: blood pressure
Lead sponsor: BTS International
Sponsor class: OTHER
Collaborators: name: BTS International
First posted: 2012-08-13
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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%.

Eligibility criteria: Inclusion Criteria:

* male,female,

Exclusion Criteria:

* below 18 years old

Primary outcomes:
measure: Verify the accuracy of measure functions of device
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Zhongshan
country: China
facility: Zhongshan City People's Hospital
state: Guangdong
Study officials:
affiliation: BTS International
name: Leo Wang, Leader
role: STUDY_CHAIR
References:
citation: Alpert BS. Validation of the Tiba Medical Ambulo 2400 ambulatory blood pressure monitor to the ISO Standard and BHS protocol. Blood Press Monit. 2010 Oct;15(5):275-7. doi: 10.1097/MBP.0b013e32833c8b39.