Pulse Oximeter Accuracy for Hypoxia
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Owlet Baby Care, Inc.
Disqualifiers: Obesity, Heart disease, Lung disease, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This study tests the accuracy of pulse oximeters in a range of arterial oxygen levels from 100% down to 70%. This is done by comparing the test pulse oximeter readings of young, healthy, adult study participants with blood samples drawn from an artery in the wrist during brief plateaus of progressively lower oxygen saturations. The arterial blood sample is processed in a device called a multi-wavelength hemoximeter and compared to the simultaneous oximeter reading. During each set level of oxygen the participant may be asked to have a motion simulator device apply different types of movement to their hands to assess the pulse oximeter's accuracy during motion. This study will be evaluating the Owlet OSS 3.0 sensor, a component in 2 FDA cleared noninvasive pulse oximeters indicated for infants 1-18 months of age.
Testing should require approximately an hour and 15 minutes of the participant's time.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, since the study involves healthy participants with no medical problems, it's likely that those on regular medications may not qualify.
What data supports the effectiveness of the treatment Owlet OSS 3.0 for hypoxia?
The research suggests that modern pulse oximeters, like the Owlet OSS 3.0, are generally accurate in measuring oxygen levels even in patients with poor blood flow, especially when placed on the earlobe. This indicates that the Owlet OSS 3.0 may be effective in accurately detecting hypoxia (low oxygen levels in the blood).
12345Is the Owlet OSS 3.0 pulse oximeter safe for use in humans?
Pulse oximeters, including newer models like the Owlet OSS 3.0, are generally safe for use in humans, but their accuracy can vary based on conditions like skin pigmentation and blood flow. They are more accurate when placed on the earlobe and in patients with good blood flow, but may be less reliable in people with darker skin or poor circulation.
15678How does the pulse oximeter treatment for hypoxia differ from other treatments?
The pulse oximeter treatment for hypoxia is unique because it focuses on accurately measuring oxygen levels in the blood, especially during low oxygen conditions, using advanced technology and algorithms. Unlike other treatments that might directly address hypoxia through medication or oxygen therapy, this approach aims to improve the precision of monitoring devices, which is crucial for effective management of the condition.
12569Eligibility Criteria
This trial is for young, healthy adults. Participants must be able to undergo brief periods of reduced oxygen levels and have blood samples taken from their wrist artery. They should also be comfortable with a motion simulator device being applied to their hands.Inclusion Criteria
I am fluent in English, both in writing and speaking.
I am in good health with no major medical issues.
The subject has provided informed consent and is willing to comply with the study procedures.
Exclusion Criteria
The subject has a history of sensitivity to local anesthesia.
The subject has any other condition, which in the opinion of the investigators, would make them unsuitable for the study.
The subject is pregnant, lactating or trying to get pregnant.
+13 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants undergo standardized plateaus of oxygen desaturation to evaluate the accuracy of the Owlet noninvasive pulse oximeter during motion and nonmotion conditions
75 minutes
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
1 week
Participant Groups
The study is testing the accuracy of the Owlet OSS 3.0 pulse oximeter by comparing its readings against arterial blood samples during controlled hypoxia (low oxygen levels) and simulated hand movements in participants.
1Treatment groups
Experimental Treatment
Group I: Hypoxia Plateau ProtocolExperimental Treatment1 Intervention
Study participants that all undergo standardized plateaus of oxygen desaturation to evaluate the accuracy of the Owlet noninvasive pulse oximeter during motion and nonmotion conditions.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Vital Signs Research GroupSan Francisco, CA
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Who Is Running the Clinical Trial?
Owlet Baby Care, Inc.Lead Sponsor
References
Accuracy of pulse oximeters in measuring oxygen saturation in patients with poor peripheral perfusion: a systematic review. [2022]One of the most significant limitations of oximeters is their performance under poor perfusion conditions. This systematic review examines pulse oximeter model accuracy in adults under poor perfusion conditions. A multiple database search was conducted from inception to December 2020. The inclusion criteria were as follows: (1) adult participants (> 18 years) with explicitly stated conditions that cause poor peripheral perfusion (conditions localized at the oximeter placement site; or systemic conditions, including critical conditions such as hypothermia, hypotension, hypovolemia, and vasoconstricting agents use; or experimental conditions) (2) a comparison of arterial oxygen saturation and arterial blood gas values. A total of 22 studies were included and assessed for reliability and agreement using a modified Guidelines for Reporting Reliability and Agreement Studies tool. We calculated the accuracy root mean square error from bias and precision we extracted from the studies. Most oximeters (75%) were deemed accurate in patients with poor perfusion. Modern oximeters utilizing more complex algorithms were more likely to be accurate than older models. Earlobe placement of oximeters seemed more sensitive, with greater measurement accuracy, than on fingertip placement. Only one study controlled for skin pigmentation, and none strictly followed Food and Drug Association recommendations for experiments to determine oximeter accuracy. Oximeters are accurate in poorly perfused patients, especially newer oximeter models and those placed on earlobes. Further studies are needed that examine multiple oximeter models used on a diverse selection of patients while following FDA recommendations to examine oximeter accuracy.
The utility of iPhone oximetry apps: A comparison with standard pulse oximetry measurement in the emergency department. [2021]To determine if a correlation exists between 3 iphone pulse ox applications' measurements and the standard pulse oximetry (SpO2) and whether these applications can accurately determine hypoxia.
Accuracy of Multiple Pulse Oximeters in Stable Critically Ill Patients. [2023]Label="BACKGROUND">An accurate SpO2 value is critical in order to optimally titrate oxygen delivery to patients and to follow oxygenation guidelines. Limited prospective data exist on real-world performance of pulse oximeters in critically ill patients. The objective of this study was to assess accuracy and bias of the SpO2 values measured by several oximeters in hospitalized subjects.
Accuracy of three pulse oximeters at low cardiac index and peripheral temperature. [2019]To assess the ability of three different pulse oximeters to give reliable readings during poor cardiac index and peripheral temperature states as compared with normal cardiac index and peripheral temperature states in the same patients.
Accuracy of pulse oximetry during hypoxemia. [2022]To determine the accuracy of four pulse oximeters during mild and moderate arterial hypoxemia, we produced stepwise arterial blood desaturation in 25 healthy, nonsmoking volunteers by adjusting the inhaled oxygen concentration. At plateaus of
Quantifying pulse oximeter accuracy during hypoxemia and severe anemia using an in vitro circulation system. [2023]Anemia and hypoxemia are common clinical conditions that are difficult to study and may impact pulse oximeter performance. Utilizing an in vitro circulation system, we studied performance of three pulse oximeters during hypoxemia and severe anemia. Three oximeters including one benchtop, one handheld, and one fingertip device were selected to reflect a range of cost and device types. Human blood was diluted to generate four hematocrit levels (40%, 30%, 20%, and 10%). Oxygen and nitrogen were bubbled through the blood to generate a range of oxygen saturations (O2Hb) and the blood was cycled through the in vitro circulation system. Pulse oximeter saturations (SpO2) were paired with simultaneously-measured O2Hb readings from a reference CO-oximeter. Data for each hematocrit level and each device were least-squares fit to a 2nd-order equation with quality of each curve fit evaluated using standard error of the estimate. Bias and average root mean square error were calculated after correcting for the calibration difference between human and in vitro circulation system calibration. The benchtop oximeter maintained good accuracy at all but the most extreme level of anemia. The handheld device was not as accurate as the benchtop, and inaccuracies increased at lower hematocrit levels. The fingertip device was the least accurate of the three oximeters. Pulse oximeter performance is impacted by severe anemia in vitro. The use of in vitro calibration systems may play an important role in augmenting in vivo performance studies evaluating pulse oximeter performance in challenging conditions.
Pulse oximeter performance during desaturation and resaturation: a comparison of seven models. [2019]To compare pulse oximeter performance during induced hypoxemia.
Pulse Oximeter Performance, Racial Inequity, and the Work Ahead. [2023]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.
Errors in 14 pulse oximeters during profound hypoxia. [2019]The accuracy of pulse oximeters from fourteen manufacturers was tested during profound brief hypoxic plateaus in 125 subject sets using 50 normal adult volunteers, of whom 29 were studied two to nine times. A data set usually consisted of 10 subjects, and 13 sets were collected between August 1987 and July 1988. In the first 6 sets, six 30-second hypoxic plateaus were obtained per subject at 55 +/- 6% oxyhemoglobin (O2Hb) (range, 40 to 70%). In the last 7 sets, three hypoxic plateaus were obtained at each of four levels, approximately 86, 74, 62, and 50% O2Hb, for the purpose of linear regression analysis. Inspired oxygen was adjusted manually breath by breath in response to arterial oxygen saturation computed on-line from end-tidal oxygen and carbon dioxide tensions. End-plateau arterial blood O2Hb was analyzed by a Radiometer OSM-3 oximeter, and plateau pulse oximeter saturation (SpO2) was read by cursor from a computer record of the analog output. Three to 13 instruments were tested simultaneously by using 1 to 3 duplicate instruments from each of one to seven manufacturers. Variations introduced by manufacturers were tested on subsequent sets in several instruments. An index of error, "ambiguity" (alpha) of oxygen saturation, was defined as the absolute sum of bias and precision (mean and SD of SpO2 - O2Hb) at O2Hb = 55.8 +/- 4.5%, preserving the sign when bias was significant at P less than 0.05. Ambiguity values for finger probes (unless specified) with latest data were: Physio-Control, 3.9 (ear, 3.3); Puritan-Bennett, -4.4; Criticare, 5.8 (forehead, 4.7); Kontron, 5.9 (infant probe) and 6.1 (ear, 5.8; forehead, 7.1); Biochem, -6.0; Datex 6.4 (ear, 6.9; forehead, 6.8); Critikon, 8.4; SiMed, 8.6; Marquest, 9.0; Novametrix, 10.2; Invivo, -12.2 (ear, -14.3); Nellcor, -15.1; Ohmeda, -21.2; and Radiometer, -21.2 (ear, -9.6). Linear regression slopes of 36 instruments from twelve manufacturers generally deviated from 1 in proportion to alpha. The data showed substantial differences in bias and precision between pulse oximeters at low saturations, the most common problems being underestimation of saturation and failing precision.