Trial Outcomes & Findings for Clinical Study About Blood Pressure Measurement Efficacy on Multifunction KEITO (NCT NCT01359748)
NCT ID: NCT01359748
Last Updated: 2014-07-29
Results Overview
The subject was measured by the two observers at the same time using the reference sphygmomanometer and double stethoscope. The observers agree to take the K5 korotkoff sound. Each observer takes notes of their own measures.
COMPLETED
NA
89 participants
Five minutes
2014-07-29
Participant Flow
To recruit the volunteers, we have complied with the limb size distribution required on Standard Association for the American National Standards Institute(ANSI)/Association for the Advancement of Medical Instrumentation (AAMI)/International Organization for Standardization (ISO): ANSI/AAMI/ISO 81060-2:2009 \[5.1.4\]
Participant milestones
| Measure |
Subjects With Wrist Size >=14.26Cm
Patients who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009. The reference Aneroid sphygmomanometer RIESTER MINIMUS II has an adjustable cuff from 24 cm to 32 cm on arm circumference.
The KEITO's cuff is not adjustable, the wrist circumference admissible is 12 to 20 cm.
|
Subjects With Wrist Size <=14.25Cm
Patients who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009. The reference Aneroid sphygmomanometer RIESTER MINIMUS II has an adjustable cuff from 24 cm to 32 cm on arm circumference.
The KEITO's cuff is not adjustable, the wrist circumference admissible is 12 to 20 cm.
|
Subjects With Wrist Size >=16.50Cm
Patients who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009. The reference Aneroid sphygmomanometer RIESTER MINIMUS II has an adjustable cuff from 24 cm to 32 cm on arm circumference.
The KEITO's cuff is not adjustable, the wrist circumference admissible is 12 to 20 cm.
|
Subjects With Wrist Size >=17.75Cm
Patients who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009. The reference Aneroid sphygmomanometer RIESTER MINIMUS II has an adjustable cuff from 24 cm to 32 cm on arm circumference.
The KEITO's cuff is not adjustable, the wrist circumference admissible is 12 to 20 cm.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
48
|
20
|
10
|
11
|
|
Overall Study
COMPLETED
|
48
|
20
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Study About Blood Pressure Measurement Efficacy on Multifunction KEITO
Baseline characteristics by cohort
| Measure |
Wrist Size <=14.25Cm
n=20 Participants
Subjects, males or females, with wrist size specified.
|
Wrist Size<=16.40 Cm
n=48 Participants
Subjects, males or females, with wrist size specified.
|
Wrist Size >=16.5 Cm
n=10 Participants
Subjects, males or females, with wrist size specified.
|
Wrist Size >=17.75
n=11 Participants
Subjects, males or females, with wrist size specified.
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
76 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Five minutesThe subject was measured by the two observers at the same time using the reference sphygmomanometer and double stethoscope. The observers agree to take the K5 korotkoff sound. Each observer takes notes of their own measures.
Outcome measures
| Measure |
Subjects
n=89 Participants
Subjects who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009
|
|---|---|
|
BP Measurements Using the Reference Auscultatory Sphygmomanometer
Systolic Maximum (mmHg)
|
186 mmHg
Standard Deviation 3.1
|
|
BP Measurements Using the Reference Auscultatory Sphygmomanometer
Diastolic Maximum (mmHg)
|
107 mmHg
Standard Deviation 3.0
|
|
BP Measurements Using the Reference Auscultatory Sphygmomanometer
Systolic Minimum (mmHg)
|
93 mmHg
Standard Deviation 3.1
|
|
BP Measurements Using the Reference Auscultatory Sphygmomanometer
Diastolic Minimum (mmHg)
|
53 mmHg
Standard Deviation 3.0
|
PRIMARY outcome
Timeframe: 30 secondsPrior starting the measurement phase using Multifunction KEITO, the under test device was reset before each new measurement. The subject has to be at rest at least 60 seconds before be measured.
Outcome measures
| Measure |
Subjects
n=89 Participants
Subjects who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009
|
|---|---|
|
BP Measurement Using Multifunction KEITO
Diastolic Minimum
|
55 mmHg
Standard Deviation 4.5
|
|
BP Measurement Using Multifunction KEITO
Systolic Maximum
|
174 mmHg
Standard Deviation 5.2
|
|
BP Measurement Using Multifunction KEITO
Diastolic Maximum
|
98 mmHg
Standard Deviation 4.5
|
|
BP Measurement Using Multifunction KEITO
Systolic Minimum
|
94 mmHg
Standard Deviation 5.2
|
Adverse Events
Wrist Size <=14.25 Cm
Wrist Size <=16.4Cm
Wrist Size >=16.5 Cm
Wrist Size >=17.75 Cm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place