Incorrect positioning of cuff for blood pressure measurement – clinical relevance and usefulness of novel cuff design. Grzegorz Bilo 1, Oscar Sala 1,2, Carlotta Perego 2, Cristina Zorzi 1,3, Juan Eugenio Ochoa Munera 1, Anna Gluszewska 4, Lan Gao 1, Cinzia Vergani 2, Laura Maria Lonati 1, Gianfranco Parati 1,2 1 Cardiology Unit, Istituto Auxologico Italiano, IRCCS, Milan, Italy; 2 Department of Health Sciences, Università di Milano-Bicocca, Milan, Italy; 3 Università di Milano, Milan, Italy; 4 Department of Internal Medicine and Gerontology, Jagiellonian University, Medical College Krakow; Poland Background Scientific societies and manufacturers recommend that arm cuff for blood pressure (BP) should be placed with the bladder centred above brachial artery for correct measurement. Although cuff malpositioning due to its rotation may be common it is not clear whether the related error is relevant. Aims 1) To assess the size of error in BP measurement due to incorrect cuff positioning 2) To evaluate the usefulness of a novel arm cuff design to overcome the problem of incorrect cuff positioning Table 1. Study measurements sequence Methods An interim analysis in 41 (out of 50 planned) subjects (selection criteria in Box 1) was performed. After 10 minutes rest two sequences of BP measurements on both arms were performed in each participant to address each of the study aims (Table 1): 1) with two mercury sphygmomanometers (one with cuff always correctly placed and the other with cuff in different positions); 2) with a mercury sphygmomanometer (cuff always in correct position) and an Omron M6Comfort (HEM-7321-E) validated oscillometric device coupled with IntelliWrap cuff placed in different positions (see Figure 1). Step Preliminary measurement 10 min rest Entry measurement 1 Entry measurement 2 Test of position relevance (Aim 1) BOX 1. Study selection criteria Inclusion: Age 18-80 years, Sinus rhythm Arm circumference 23 - 42 cm Stable clinical conditions Written informed consent Exclusion: History of peripheral artery disease Radial pulse asymmetry or BP difference between arms >5 mmHg Deformations of any arm which could interfere with accurate measurement Arm lymphedema Relevant arrhythmias (frequent ectopic beats, atrial fibrillation/flutter, bradycardia <50 bpm) Cardiac pacemaker Patients on oral anticoagulants or with known coagulation alterations Patient with skin lesions on upper arm(s) Pregnancy Preliminary measurement Test of IntelliWrap cuff (Aim 2) Figure 1. Omron M6-Comfort with IntelliWrap cuff Arm 1 * Arm 2 * Device Cuff position Device Cuff position AU Correct AU Correct AU Correct AU Correct AU Correct AU Correct AU AU AU AU AU AU AU AU AU Correct 90° medially 180° 90° laterally 90° laterally 180° 90° medially Correct Correct AU AU AU AU AU AU AU AU OSC Correct Correct Correct Correct Correct Correct Correct Correct Correct AU AU AU AU AU AU OSC OSC OSC OSC OSC OSC Correct Correct Correct Correct Correct Correct Correct 90° laterally 180° 180° 90° laterally Correct OSC OSC OSC OSC OSC OSC AU AU AU AU AU AU Correct 90° laterally 180° 180° 90° laterally Correct Correct Correct Correct Correct Correct Correct * - the assignment of sides (left/right) to arms 1 and 2 was done in a random manner AU – auscultatory mercury device with standard cuff; OSC – oscillometric Omron M6-Comfort (HEM-7321-E) device coupled with IntelliWrap cuff Results Population characteristics: age 50.7±16.0, 26M/15F, BMI 32.8±7.9 kg/m2, arm circumference 33.3±4.4cm The effects of different cuff positions on BP values measured with auscultatory or oscillometric device are shown in Figure 2. There was no difference between arms with auscultatory measurements (mean SBP/DBP difference was -0.37±2.5 /-0.05±1.8 mmHg) Oscillometric device produced BP values which were on average lower than those measured with mercury device (mean SBP/DBP difference was -3.8±8.0/-4.6±7.6 mmHg when both devices were in correct position). This appears to be due to relative undercuffing with mercury device equipped with standard size cuff in subjects with larger arm. For major clarity the between-arm differences for incorrect positions shown in Figure 2 are corrected for the mean between-arm difference with both devices in correct position. Figure 2. Effect of incorrect positions of BP measurement cuff of auscultatory (left) and Omron+IntelliWrap (right) device. The values represent difference between BP measured in the indicated cuff position and BP measured with auscultatory device in correct position on the opposite arm and are corrected for the difference observed when both cuffs were in correct positions. Minus sign indicates underestimation of BP compared with correct position. All BP values in mmHg Conclusions Interim results of our study show that incorrect positioning of conventional cuff significantly affects BP measurement results, with BP overestimation particularly evident when the bladder centre is displaced by 90° laterally or by 180° compared to correct position. No effect of cuff position was observed when IntelliWrap cuff was used. BP values obtained with oscillometric device tended to be lower than those obtained by reference method because of relative undercuffing with mercury device equipped with standard size cuff in subjects with large arm circumference. Study supported by Omron Healthcare Europe
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