Glenning Jonathan P, Sheeran Freya, Cuthbert Jodie, Harris William, Quinlan Catherine, Mynard Jonathan P
Heart Research, Murdoch Children's Research Institute, Parkville, VIC, Australia.
Department of Paediatrics, University of Melbourne, Parkville, VIC, Australia.
Hypertens Res. 2025 Mar;48(3):1125-1134. doi: 10.1038/s41440-024-01992-1. Epub 2024 Dec 24.
To (1) assess the accuracy of the Uscom BP+ oscillometric upper-arm professional blood pressure (BP) monitor in children and adolescents as per the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018); (2) assess the suitability of a non-standard cuff; and (3) assess the impact of motion artefact on device accuracy and precision. Children and adolescents were recruited to fulfil the sex/cuff distribution criteria of the Universal Standard. Single arm sequential BP measurements were used, the test device measured on deflate with an altered child/adolescent algorithm, using three standard (Extra Small, Small Adult, Adult) and, as exploratory analysis, additionally in one non-standard cuff (Wide Range; WR) (arm circumferences: 12-17, 16-24, 22-32, 22-42 cm, respectively). The presence of motion artefact was determined and its impact on BP assessed. One-hundred-forty participants were recruited with 123 included for analysis. When using the Extra Small, Small Adult and Adult cuffs only, the BP+ passed both criteria (95 participants, 321 pairs, -0.1 ± 7.3/ - 1.6 ± 7.6 and 5.72/6.50 mmHg systolic/diastolic) (reference thresholds: ≤5 ± 8, ≤6.95/6.76, respectively). The inclusion of the WR cuff showed unacceptable imprecision, and motion artefact had a substantial influence on test device precision. The Uscom BP+ fulfilled the requirements of the Universal Standard in children and adolescents when using the altered algorithm with the three standard cuffs and can be recommended for clinical use. The WR cuff cannot be recommended in this population in measure-on-deflate mode due to its imprecision. Additionally, BP measurement accuracy in children and adolescents can be improved through inclusion of a motion artefact detection system.
(1) 根据美国医疗器械促进协会（AAMI）/欧洲高血压学会（ESH）/国际标准化组织（ISO）通用标准（ISO 81060-2:2018）评估Uscom BP+振荡式上臂专业血压计在儿童和青少年中的准确性；(2) 评估非标准袖带的适用性；(3) 评估运动伪影对设备准确性和精密度的影响。招募儿童和青少年以满足通用标准的性别/袖带分布标准。采用单臂序贯血压测量，测试设备在放气时使用针对儿童/青少年的改良算法进行测量，使用三种标准袖带（超小号、成人小号、成人袖带），作为探索性分析，还额外使用了一种非标准袖带（宽范围袖带；WR）（臂围分别为12 - 17、16 - 24、22 - 32、22 - 42厘米）。确定运动伪影的存在并评估其对血压的影响。招募了140名参与者，其中123名纳入分析。仅使用超小号、成人小号和成人袖带时，BP+通过了两项标准（95名参与者，321对，收缩压/-0.1±7.3 /舒张压/-1.6±7.6以及5.72/6.50毫米汞柱）（参考阈值分别为≤5±8、≤6.95/6.76）。纳入WR袖带显示精密度不可接受，并且运动伪影对测试设备的精密度有重大影响。当使用针对三种标准袖带的改良算法时，Uscom BP+满足儿童和青少年通用标准的要求，可推荐用于临床。由于其不精确性，在该人群的放气测量模式下不推荐使用WR袖带。此外，通过纳入运动伪影检测系统可以提高儿童和青少年血压测量的准确性。
