Text Size

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
History of Changes
  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:

U.S. FDA Resources

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
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

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

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 May 16, 2013