Factors affecting blood pressure measurement validations - v 1.0
Research type
Research Study
Full title
Analysis of physical and human factors affecting blood pressure measurement with especial relevance to validations of blood pressure monitors in man
IRAS ID
197681
Contact name
Philip S Lewis
Contact email
Sponsor organisation
Omron Healthcare Europe B.V.
ISRCTN Number
ISRCTN35694
Clinicaltrials.gov Identifier
ISRCTN being applied for, 33522
Duration of Study in the UK
0 years, 7 months, 31 days
Research summary
WHY? Using a standard international protocol for comparing machine blood pressures with those obtained manually, a recent unpublished UK study in 2015 showed less comparability than a study using the same machine in France published in the previous year. Based on our previous and current research, we believe that a variety of factors might lead to such a disparity including differences in 1) the accuracy of the observers' assessment of the blood pressure sounds, 2) physical characteristics of the subjects used, 3) the effect of exchanging the cuffs between readings and 4) differences in the recovery of blood flow in the arm dependent on variations in the time between readings allowed within the protocol. We wish to investigate whether such variations can be circumvented in order to produce a better validation protocol.
WHAT? We aim to explore these and other factors using a more rigorous, detailed and comprehensive version of the same validation protocol (IP2) using a larger number of participants (80 instead of 33) with the same (Omron M6) automatic blood pressure monitor. We hope that the results may suggest ways to improve the design of validation protocols and thereby to facilitate the development of even more accurate and reliable monitors.
WHO? We will use healthy volunteers aged between 18 and 85 years who have systolic blood pressures on or off therapy between 90 and 180 mm Hg.
WHERE? This study will be performed in the Blood Pressure and Heart Research Centre at Stepping Hill Hospital, Stockport, where many similar studies have been performed previously.
HOW? Suitable subjects will attend the Research Centre on a single occasion for repeated blood pressure measurements accompanied by some non-invasive measurements of arm size and blood flow.
REC name
North of Scotland Research Ethics Committee 1
REC reference
17/NS/0075
Date of REC Opinion
14 Aug 2017
REC opinion
Further Information Favourable Opinion