|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT01359748 |
|
Date of registration:
|
16/05/2011 |
|
Primary sponsor: |
|
|
Public title:
|
Clinical Study About Blood Pressure Measurement Efficacy on Multifunction Keito
|
|
Scientific title:
|
Clinical Study About Blood Pressure Measurement Efficacy on Multifunction Keito |
|
Date of first enrolment:
|
March 2011 |
|
Target sample size:
|
89 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01359748 |
|
Study type:
|
Observational |
|
Study design:
|
N/A
|
|
|
Contacts
|
|
Name:
|
Angel P Ferre, Telecommunications Engineer |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
Francisco B Contreras, Electronic Technician |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Wrist circumference: 12 to 20 Cm
- Systolic <=100 mmHg
- Systolic >=160 mmHg
- Systolic >=140 mmHg
- Diastolic <=60 mmHg
- Diastolic >=100 mmHg
- Diastolic >=85 mmHg
Exclusion Criteria:
- Pregnant Women
Age minimum:
18 Years
Age maximum:
83 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
The Focus of Study is to Determine Efficiency and Accuracy of the Multifunction Keito Under the ANSI/AAMI/ISO 81060-2:2009.
|
|
Primary Outcome(s)
|
|
Operator measurements using the Same Arm sequential method as indicated on [5.2.4.2] of the Standard applied.
[Time Frame: Two weeks]
|
|
Secondary Outcome(s)
|
|
Multifunction Keito BP measurement.[5.2.4.2] of the standard applied
[Time Frame: Two Weeks.]
|
|
Secondary ID(s)
|
|
K8-BP-31032011
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|