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Accuracy of Rhythm Diagnostic Systems' MultiSense ® in Detection of Arterial Oxygen Saturation and Respiratory Rate During Hypoxia in Humans: Effects of Skin Color and Device Localization.

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  • معلومة اضافية
    • المصدر:
      Publisher: MDPI Country of Publication: Switzerland NLM ID: 101204366 Publication Model: Electronic Cited Medium: Internet ISSN: 1424-8220 (Electronic) Linking ISSN: 14248220 NLM ISO Abbreviation: Sensors (Basel) Subsets: MEDLINE
    • بيانات النشر:
      Original Publication: Basel, Switzerland : MDPI, c2000-
    • الموضوع:
      Oxygen Saturation*/physiology ; Oximetry*/instrumentation ; Oximetry*/methods ; Hypoxia*/diagnosis ; Hypoxia*/physiopathology ; Skin Pigmentation*/physiology ; Respiratory Rate*/physiology ; Oxygen*/blood; Humans ; Male ; Adult ; COVID-19 ; SARS-CoV-2 ; Reproducibility of Results ; Monitoring, Physiologic/methods
    • نبذة مختصرة :
      The continuous monitoring of oxygen saturation (SpO 2 ) and respiratory rates (RRs) are major clinical issues in many cardio-respiratory diseases and have been of tremendous importance during the COVID-19 pandemic. The early detection of hypoxemia was crucial since it precedes significant complications, and SpO 2 follow-up allowed early hospital discharge in patients needing oxygen therapy. Nevertheless, fingertip devices showed some practical limitations. In this study, we investigated the reliability of the new Multisense ® pulse oximetry system compared to a reference pulse oximeter (Vyntus CPX Pulse Oximeter) during hypoxia. In a population of sixteen healthy male subjects (mean age: 31.5 ± 7.0 years, BMI: 24.9 ± 3.6 kg/m², and 35% with darker skin tones), simultaneous SpO 2 and RR measurements were collected over 12.4 h, during which FiO 2 was progressively reduced from 21% to 10.5%. The average root mean square error (ARMS) of SpO 2 for Multisense ® placed on the back and chest was 2.94% and 2.98%, respectively, with permutation testing confirming a significant ARMS below 3.5% for both positions and no statistically significant difference in the ARMS between patch placements. Positive correlations and acceptable accuracy between devices were observed at both locations (r = 0.92, p < 0.001 and r = 0.90, p < 0.001 for back and chest placements, respectively). Bland-Altman analysis further indicated limits of agreement that support consistency across placements, with similar agreement levels noted across skin tones. Similar findings were obtained with the RR measurements. In conclusion, Multisense ® demonstrated robust accuracy in measuring SpO 2 and RRs during hypoxia in humans comparable to standard hospital-grade equipment. The effectiveness of the findings suggests that this wearable device is a valuable tool for the continuous monitoring of SpO 2 and RRs, potentially enhancing patient safety and optimizing hospital resource allocation. Nevertheless, to overcome study limitations and allow generalized use, further work on a larger population sample, including more subjects with a high phototype and desaturation below 80%, would be useful.
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    • Grant Information:
      no number Rhytm diagnostic sysytem
    • Contributed Indexing:
      Keywords: SpO2; hypoxia; pulse oximeter; pulse oxygen saturation; respiratory rate; sensors; wearable device
    • الرقم المعرف:
      S88TT14065 (Oxygen)
    • الموضوع:
      Date Created: 20250111 Date Completed: 20250430 Latest Revision: 20250430
    • الموضوع:
      20250501
    • الرقم المعرف:
      PMC11722614
    • الرقم المعرف:
      10.3390/s25010127
    • الرقم المعرف:
      39796917