The performance of 11 fingertip pulse oximeters during hypoxemia in healthy human participants with varied, quantified skin pigment.

BACKGROUND: Fingertip pulse oximeters are widely available, inexpensive, and commonly used to make clinical decisions in many settings. Device performance is largely unregulated and poorly characterised, especially in people with dark skin pigmentation. METHODS: Eleven popular fingertip pulse oximeters were evaluated using the US Food and Drug Administration (FDA) Guidance (2013) and International Organization for Standardization Standards (ISO, 2017) in 34 healthy humans with diverse skin pigmentation utilising a controlled desaturation study with arterial oxygen saturation (SaO 2) plateaus between 70% and 100%. Skin pigmentation was assessed subjectively using a perceived Fitzpatrick Scale (pFP) and objectively using the individual typology angle (ITA) via spectrophotometry at nine anatomical sites. FINDINGS: Five of 11 devices had a root mean square error (ARMS) > 3%, falling outside the acceptable FDA performance range. Nine devices demonstrated worse performance in participants in the darkest skin pigmentation category compared with those in the lightest category. A commonly used subjective skin colour scale frequently miscategorised participants as being darkly pigmented when compared to objective quantification of skin pigment by ITA. INTERPRETATION: Fingertip pulse oximeters have variable performance, frequently not meeting regulatory requirements for clinical use, and occasionally contradicting claims made by manufacturers. Most devices showed a trend toward worse performance in participants with darker skin pigment. Regulatory standards do not adequately account for the impact of skin pigmentation on device performance. We recommend that the pFP and other non-standardised subjective skin colour scales should no longer be used for defining diversity of skin pigmentation. Reliable methods for characterising skin pigmentation to improve diversity and equitable performance of pulse oximeters are needed. FUNDING: This study was conducted as part of the Open Oximetry Project funded by the Gordon and Betty Moore Foundation, Patrick J McGovern Foundation, and Robert Wood Johnson Foundation. The UCSF Hypoxia Research Laboratory receives funding from multiple industry sponsors to test the sponsors' devices for the purposes of product development and regulatory performance testing. Data in this paper do not include sponsor's study devices. All data were collected from devices procured by the Hypoxia Research Laboratory for the purposes of independent research. No company provided any direct funding for this study, participated in study design or analysis, or was involved in analysing data or writing the manuscript. None of the authors own stock or equity interests in any pulse oximeter companies. Dr Ellis Monk's time utilised for data analysis, reviewing and editing was funded by grant number: DP2MH132941.

Integrating IPACK (Interspace between the Popliteal Artery and Capsule of the Posterior Knee) Block in an Enhanced Recovery after Surgery Pathway for Total Knee Arthroplasty-A Prospective Triple-Blinded Randomized Controlled Trial.

We explored the efficacy of an interspace between the popliteal artery and capsule of the posterior knee (IPACK) block when added to an established enhanced recovery after surgery (ERAS) pathway to assist with posterior knee analgesia and functional mobility after total knee arthroplasty (TKA). We recruited participants undergoing TKA in our prospective, randomized, triple-blinded controlled trial. All study patients participated in our ERAS pathway consisting of a primary spinal anesthetic, adductor canal nerve catheter, and periarticular joint infiltration. Patients were randomized to receive an IPACK block or no block. The primary outcome was total postoperative opioid consumption. Secondary outcomes included pain scores, recovery unit length of stay, time to first opioid use, the incidence of posterior knee pain, ambulation distance and activities of daily living on postoperative day 1, and hospital length of stay. A total of 96 patients were randomized to the control and IPACK groups. There were no statistical differences in primary or majority of secondary outcomes. There was a lower incidence of posterior knee pain (39%) in the IPACK group when compared with controls (8.7%), p < 0.01. In terms of opioid consumption and a majority of functional outcomes, our study demonstrates no overall benefits of adding an IPACK block in this ERAS pathway in TKA. Nevertheless, IPACK may have the potential of mitigating posterior knee pain after TKA. LEVEL OF EVIDENCE: level 1. CLINICAL TRIAL NUMBER AND REGISTRY URL: NCT03653416. www. CLINICALTRIALS: gov.

Pulse Oximeter Performance, Racial Inequity, and the Work Ahead.

It has long been known that many pulse oximeters function less accurately in patients with darker skin. Reasons for this observation are incompletely characterized and potentially enabled by limitations in existing regulatory oversight. Based on decades of experience and unpublished data, we believe it is feasible to fully characterize, in the public domain, the factors that contribute to missing clinically important hypoxemia in patients with darkly pigmented skin. Here we propose 5 priority areas of inquiry for the research community and actionable changes to current regulations that will help improve oximeter accuracy. We propose that leading regulatory agencies should immediately modify standards for measuring accuracy and precision of oximeter performance, analyzing and reporting performance outliers, diversifying study subject pools, thoughtfully defining skin pigmentation, reporting data transparently, and accounting for performance during low-perfusion states. These changes will help reduce bias in pulse oximeter performance and improve access to safe oximeters.