Edwards ClearSight

Description:

The Edwards ClearSight is a patient monitor. Although its blood pressure measurement technology has been evaluated, it is not possible to base a determination on its accuracy from this research. Blood pressure measurements are taken from the finger. It is intended for bedside patient monitoring.

Assessment:

The technology used in the Edwards ClearSight, to measure blood pressure, has failed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication. It has also been assessed, in a specific population, according to a non-standard protocol.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	None	When an evaluation is carried out using a non-standard protocol, no inference can be made on accuracy based on a standard protocol.

Validation Publications:

Fassaert LMM, Plate JDJ, Westerink J, Immink RV, de Borst GJ. The ClearSight System for Postoperative Arterial Blood Pressure Monitoring After Carotid Endarterectomy: A Validation Study. Am J Hypertens. 2022 Feb 1;35(2):164-172. doi: 10.1093/ajh/hpab140. PMID: 34505631. Available from: PMC8807161.

81060-2:2009 - Fail Postoperative subjects (n=48), IA validation (Note: Fail for SBP and DBP, even after corrections. Pass for MAP.)

Helmer P, Helf D, Sammeth M, Winkler B, Hottenrott S, Meybohm P, Kranke P. The Use of Non-Invasive Continuous Blood Pressure Measuring (ClearSight®) during Central Neuraxial Anaesthesia for Caesarean Section-A Retrospective Validation Study. J Clin Med. 2022 Aug 2;11(15):4498. doi: 10.3390/jcm11154498. PMID: 35956113. Available from: PMC9369920.

Ad Hoc protocol n=31

Unreferenced "AAMI" partial criteria were "considered acceptable".

Kho E, van der Ster BJP, van der Ven WH, Vlaar APJ, Immink RV, Veelo DP. Clinical agreement of a novel algorithm to estimate radial artery blood pressure from the non-invasive finger blood pressure. J Clin Anesth. Epub: 2022 Sep 26;83:110976 p. doi: 10.1016/j.jclinane.2022.110976. PMID: 36174389. Available from: www.sciencedirect.com.

Ad Hoc protocol n=33

Not independent; Failed Criterion 1 of ISO 81060-2:2019; Error grid criteria used.