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

The continuous monitoring of oxygen saturation (SpO2) 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 complication...

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Bibliographic Details
Published in:Sensors (Basel, Switzerland) Vol. 25; no. 1; p. 127
Main Authors: Evrard, Charles, El Attaoui, Amina, Pistea, Cristina, Enache, Irina, Marriott, Mark, Mayaud, Louis, Charloux, Anne, Geny, Bernard
Format: Journal Article
Language:English
Published: Switzerland MDPI AG 01.01.2025
MDPI
Subjects:
Accuracy
Adhesives
Adult
Cardiology and cardiovascular system
Chronic obstructive pulmonary disease
Comparative analysis
COVID-19
Edema
Hemoglobin
Hospitals
Human health and pathology
Humans
Hypertension
Hypoxemia
Hypoxia
Hypoxia - diagnosis
Hypoxia - physiopathology
Informed consent
Life Sciences
Male
Medical equipment
Monitoring, Physiologic - methods
Oximetry
Oximetry - instrumentation
Oximetry - methods
Oxygen - blood
Oxygen saturation
Oxygen Saturation - physiology
Patients
Physiology
Population
pulse oximeter
Pulse oximetry
pulse oxygen saturation
Quality of life
Questionnaires
Reproducibility of Results
Respiratory distress syndrome
respiratory rate
Respiratory Rate - physiology
Sensors
Skin
Skin Pigmentation - physiology
SpO2
Volunteers
France
Germany
wearable device
hypoxia
pulse oxygen saturation
sensors
respiratory rate
SpO2
pulse oximeter
SpO 2
B hypoxia sensors pulse oximeter pulse oxygen saturation SpO 2 respiratory rate wearable device
ISSN:1424-8220, 1424-8220
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Summary:The continuous monitoring of oxygen saturation (SpO2) 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 SpO2 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 SpO2 and RR measurements were collected over 12.4 h, during which FiO2 was progressively reduced from 21% to 10.5%. The average root mean square error (ARMS) of SpO2 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 SpO2 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 SpO2 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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ISSN:1424-8220
1424-8220
DOI:10.3390/s25010127