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

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ClinicalTrials.gov Identifier: NCT01295528
Recruitment Status : Completed
First Posted : February 14, 2011
Last Update Posted : February 14, 2011
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment
Hypertension Device: Comparison test

  Show Detailed Description

Study Design

Study Type : Observational
Actual Enrollment : 95 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Verify the functionS of BPM TMB-986 to Comply With ANSI/AAMI SP10
Study Start Date : May 2010
Primary Completion Date : May 2010
Study Completion Date : October 2010
Groups and Cohorts

Group/Cohort Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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 ( Other Identifier: BTSInternational )
First Posted: February 14, 2011    Key Record Dates
Last Update Posted: February 14, 2011
Last Verified: February 2011

Keywords provided by BTS International:
blood pressure
heart rate