In:
BMJ Open Respiratory Research, BMJ, Vol. 8, No. 1 ( 2021-09), p. e000939-
Kurzfassung:
To evaluate the performance of direct-to-consumer pulse oximeters under clinical conditions, with arterial blood gas measurement (SaO 2 ) as reference standard. Design Cross-sectional, validation study. Setting Intensive care. Participants Adult patients requiring SaO 2 -monitoring. Interventions The studied oximeters are top-selling in Europe/USA (AFAC FS10D, AGPTEK FS10C, ANAPULSE ANP 100, Cocobear, Contec CMS50D1, HYLOGY MD-H37, Mommed YM101, PRCMISEMED F4PRO, PULOX PO-200 and Zacurate Pro Series 500 DL). Directly after collection of a SaO 2 blood sample, we obtained pulse oximeter readings (SpO 2 ). SpO 2 -readings were performed in rotating order, blinded for SaO 2 and completed 〈 10 min after blood sample collection. Outcome measures Bias (SpO 2 –SaO 2 ) mean, root mean square difference (A RMS ), mean absolute error (MAE) and accuracy in identifying hypoxaemia (SaO 2 ≤90%). As a clinical index test, we included a hospital-grade SpO 2 -monitor (Philips). Results In 35 consecutive patients, we obtained 2258 SpO 2 -readings and 234 SaO 2 -samples. Mean bias ranged from −0.6 to −4.8. None of the pulse oximeters met A RMS ≤3%, the requirement set by International Organisation for Standardisation (ISO)-standards and required for Food and Drug Administration (FDA) 501(k)-clearance. The MAE ranged from 2.3 to 5.1, and five out of ten pulse oximeters met the requirement of ≤3%. For hypoxaemia, negative predictive values were 98%–99%. Positive predictive values ranged from 11% to 30%. Highest accuracy (95% CI) was found for Contec CMS50D1; 91% (86–94) and Zacurate Pro Series 500 DL; 90% (85–94). The hospital-grade SpO 2 -monitor had an A RMS of 3.0% and MAE of 1.9, and an accuracy of 95% (91%–97%). Conclusion Top-selling, direct-to-consumer pulse oximeters can accurately rule out hypoxaemia, but do not meet ISO-standards required for FDA-clearance
Materialart:
Online-Ressource
ISSN:
2052-4439
DOI:
10.1136/bmjresp-2021-000939
Sprache:
Englisch
Verlag:
BMJ
Publikationsdatum:
2021
ZDB Id:
2736454-9
