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Factors affecting blood pressure measurement validations

Analysis of physical and human factors affecting blood pressure measurement with especial relevance to validations of blood pressure monitors in man

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN69536660
Enrollment
80
Registered
2020-04-29
Start date
2018-08-06
Completion date
Unknown
Last updated
2020-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood pressure measurement Not Applicable

Interventions

The researchers will recruit 80 volunteers and measure specific physical characteristics which may influence blood pressure measurement e.g. weight, height, arm size and pulse velocity. Then they will

Sponsors

Omron Healthcare UK
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy volunteers aged between 18 and 85 years of age 2. Willing to have repeated blood pressure measured whilst sitting silently in four sequences of 9 readings in any one sequence 3. Resting heart rate between 50-110 bpm 4. Upper arm circumference = 22 cm and = 42 cm 5. Resting systolic blood pressure = 90 and = 180 mm Hg

Exclusion criteria

Exclusion criteria: Participants who: 1. Take anticoagulants 2. Bruise easily 3. Have circulatory problems (e.g. have an arterial shunt or arterial narrowing) 4. Have a pacemaker 5. Have atrial fibrillation 6. Have any other marked pulse irregularity 7. Have a resting heart rate 110 bpm 8. Have systolic and/or diastolic blood pressure sounds in either arm which are not easily heard by the observers 9. Have initial systolic and/or diastolic blood pressures in either arm which differ by > 4 mmHg 10. Have systolic blood pressure at rest 180 mmHg 11. Have blood pressure differences between arms at rest of = 20 mmHg systolic and/or = 10 mmHg diastolic 12. Have disorders of upper arm anatomy, muscle tone, tremor or power 13. Take medications or substances likely to cause short term changes in blood flow or pressure 14. Those who have had caffeine-containing drinks, alcohol or nicotine within 4 hours of the beginning of the study 15. Those lacking capacity to provide informed consent

Design outcomes

Primary

MeasureTime frame
Systolic and diastolic blood pressure measured manually by two observers using standard auscultation and a mercury-containing sphygmomanometer, by an automated blood pressure recorder (Omron M6), by microphone, Doppler waveform and continuous sphygmomanometer cuff pressure waveform and video-recording of the mercury column in two sequences of nine blood pressure readings made alternately manually (with an appropriately sized Accoson cuff) or by the Omron M6 (using an Omron cuff) at 30 or 60 second intervals

Secondary

MeasureTime frame
1. Systolic and diastolic blood pressure measured manually by two observers using standard auscultation and a mercury-containing sphygmomanometer, by an automated blood pressure recorder (Omron M6), by microphone, Doppler waveform and continuous sphygmomanometer cuff pressure waveform and video-recording of the mercury column made alternately manually or by the Omron M6 in two sequences of nine blood pressure readings at 60-second intervals. One sequence will use the Omron cuff and the other will use a specially constructed cuff which resembles the Omron cuff in size and shape but differs in using the same materials as the previously-used Accoson cuffs. 2. Continuous finger blood pressure measured using a Portapres recorder on the contralateral side during all four sequences 3. Upper arm circumference measured with a spring-loaded tape measure and triceps skin-fold thickness measured using callipers before and after each sequence of nine blood pressure measurements 4. Bilateral pulse wave velocity (carotid-radial) measured using a Complior device before and after each sequence of nine blood pressure measurements

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026