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

This study has been completed.
Sponsor:
Collaborator:
West China Hospital
Information provided by:
BTS International
ClinicalTrials.gov Identifier:
NCT01295528
First received: January 26, 2011
Last updated: February 11, 2011
Last verified: February 2011
  Purpose

The clinical protocol of the clinical testing of this device:

  1. Objective of the test: To verify the function of device.
  2. Test methods and procedures: Performance test in two positions: Seated and Supine.
  3. DUT: Transtek Blood Pressure Monitor, Model: TMB-986. Cuff size: 22-32cm and 22-42cm.
  4. Comparison device: Yuyue medical BP meter, accuracy: ±1mmHg and range: 0-300mmHg.
  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.

Condition Intervention
Hypertension
Device: Comparison test

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Verify the functionS of BPM TMB-986 to Comply With ANSI/AAMI SP10

Resource links provided by NLM:


Further study details as provided by BTS International:

Primary Outcome Measures:
  • Verify the accuracy of measure functions of device [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
    Verify the accuracy of device if meet the requirements of ANSI/AAMI SP10 when it measure Systolic & Diastolic blood pressure.


Enrollment: 95
Study Start Date: May 2010
Study Completion Date: October 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Blood Pressure, Heart Rate, Monitor Device: Comparison test
Yuyue medical BP meter, accuracy: ±1mmHg and range: 0-300mmHg.
Other Names:
  • Brand names: Yuyue
  • Serial numbers: YYBP20091123089
  • Code name: BP212

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

The subject population included patients suffering from hypertension, labile hypertension, normal, and hypotension. The 95 patients had a wide range in age, weight, height, heart rate, systolic and diastolic blood pressures.

18~99 years old. Male or Female. Arm circumference in 22-42cm.

Criteria

Inclusion Criteria:

  • male,female,

Exclusion Criteria:

  • below 18 years old
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01295528

Locations
China, Sichuan
Wuhou District Hospital
Chengdu, Sichuan, China, 610041
Sponsors and Collaborators
BTS International
West China Hospital
Investigators
Principal Investigator: Guoqing Li, Director Wuhou District Hospital
  More Information

Publications:
Responsible Party: James Zhu, West China College clinical trial team
ClinicalTrials.gov Identifier: NCT01295528     History of Changes
Other Study ID Numbers: Transtek BPM TMB-986, BTS-TRANS01
Study First Received: January 26, 2011
Last Updated: February 11, 2011
Health Authority: China: Ministry of Health

Keywords provided by BTS International:
blood pressure
heart rate

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 16, 2014