Performance of popular pulse oximeters compared with simultaneous arterial oxygen saturation or clinical-grade pulse oximetry: a cross-sectional validation study in intensive care patients

Abstract

ObjectivesTo evaluate the performance of direct-to-consumer pulse oximeters under clinical conditions, with arterial blood gas measurement (SaO2) as reference standard.DesignCross-sectional, validation study.SettingIntensive care.ParticipantsAdult patients requiring SaO2-monitoring.InterventionsThe 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 SaO2 blood sample, we obtained pulse oximeter readings (SpO2). SpO2-readings were performed in rotating order, blinded for SaO2 and completed <10 min after blood sample collection.Outcome measuresBias (SpO2–SaO2) mean, root mean square difference (ARMS), mean absolute error (MAE) and accuracy in identifying hypoxaemia (SaO2 ≤90%). As a clinical index test, we included a hospital-grade SpO2-monitor (Philips).ResultsIn 35 consecutive patients, we obtained 2258 SpO2-readings and 234 SaO2-samples. Mean bias ranged from −0.6 to −4.8. None of the pulse oximeters met ARMS ≤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 SpO2-monitor had an ARMS of 3.0% and MAE of 1.9, and an accuracy of 95% (91%–97%).ConclusionTop-selling, direct-to-consumer pulse oximeters can accurately rule out hypoxaemia, but do not meet ISO-standards required for FDA-clearance

The effects of skin pigmentation on the accuracy of pulse oximetry in measuring oxygen saturation: a systematic review and meta-analysis

“…Seven of the 15 studies (with 503 participants) were not included in meta-analysis (Supporting Information Table S6): [38,[41][42][43][44]53,54] six compared differences in mean bias between pigmentation levels, rather than reporting mean bias by levels of skin pigmentation. Where relevant and available we present data by device type in Supporting Information Table S6, there may be some variation in the amount of mean bias based on device used but data are too limited to draw further conclusions.…”

“…Using QUADAS-2, we considered 14/32 studies (43.75%) to be at unclear risk of bias for all four domains or high risk of bias for at least one domain, [34,38,44,47,48,53,54,[56][57][58][59][60][61]63] and the remaining 18 (56.25%) to be at low risk of bias for at least one of the four domains (Figure 2).…”

“…Key limitations in downgrading risk of bias were: (1) for the patient selection domain, where specific sub-populations were inappropriately excluded from a study [61] or there was no explicit exclusion or even inclusion criteria (19 studies); (2) for index test and reference standard domains, where there was no blinding information for either pulse oximetry SpO2 measurements (20 studies) or CO-oximeter SaO2 readings (30 studies); and (3) for the flow and timing domain, where there were sub-optimally long time intervals between SpO2 readings and the arterial blood sampling for SaO2 measurement, [44] or the exclusion of participants (3/25, 12.00%) from study data analysis without rationale. [59] We judged the applicability concern as high for one study, [60] moderate for 13 studies, [33,36,37,40,42,43,47,48,51,56,57,59,62] and low in terms of all three applicability considerations for the remaining 18 studies.…”

“…Fifteen of the 32 studies (1800 participants) reported by level of skin pigmentation. [32,34,35,[37][38][39][40][41][42][43][44][51][52][53][54]63] Eight of these studies (1297 participants) had available data and were included in the meta-analyses: [32,34,35,37,39,40,51,52,63] Supporting Information Table S4 presents the mapping of originally reported terms of skin pigmentation into 'low', 'medium' or 'high' pigmentation categories. Table 2 presents pooled association data (further data detail along with GRADE assessment details are found in Supporting Information Figures S1-S3 and Table S5).…”

Feasibility of screening for critical congenital heart disease using pulse oximetry in Indonesia

“…Knowing these recommendations is important in understanding the risk of measurement inaccuracy and providing the highest outcomes [ 26 ]. Nevertheless, a recent study revealed that a pulse oximetry device provided good accuracy in ruling out hypoxemia in comparison to saturation reading by arterial blood gas sample [ 27 ].…”