Evaluation of the Melanin-Adjusted Blood Oxygen Sensor (MABOS) in ICU Settings: Improving the Accuracy in Critical Conditions for Patients of Color
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Accuracy of MABOS by Comparing SpO2 Percent Blood Oxygen Saturation to SaO2 Percent Blood Oxygen Saturation Utilizing ARMS Calculation Calculation
研究概览
简要总结
Purpose: Investigate the accuracy of the investigators' novel pulse oximeter across a broad range of skin-pigmentations and oxygen saturations.
Participants: Up to 120 adult participants admitted to Medical Intensive Care, or Cardiovascular Thoracic Critical Care, Units.
Procedures (methods): Participants will have their skin tone measured on each finger using a spectrophotometer. During the study, participants will wear one of the investigators' custom devices - MABOS - on one finger of each hand. Additionally, they will wear a variant of the investigators' device on an additional finger and outer side of the associated wrist. The study team will continuously acquire data from all devices until either 4 Arterial Blood Gas tests have been collected, or 24 hours have elapsed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ranges from 18 to 85 years.
- •Individuals admitted to one of UNC Hospital's intensive care units (Medical Intensive Care Unit or Cardiovascular and Thoracic Intensive Care Unit).
- •Individuals with a medical condition necessitating a minimum of two arterial blood gas measurements within a 24-hour period.
- •Participant, or Legally Authorized Representative (LAR) must be able to read, write, and speak English fluently.
排除标准
- •History of active (clinically significant) skin disorders that make skin vulnerable to contact with conventional electronic devices.
- •History of allergic response to silicones, adhesives (such as 3M Tegaderm), or acetone.
- •Broken, damaged or irritated skin or rashes near the sensor application sites.
- •Presence of tattoos on the fingers, hands, or forearms.
- •History of a genetic condition or skin disorder that variably impacts the amount of melanin pigmentation (e.g., Vitiligo).
- •Pregnant or lactating individuals
- •Individuals given methylene blue within the last 24 hours or Hydroxocobalamin within the last 2 weeks.
- •Individuals experiencing carbon monoxide poisoning.
- •History of conditions that may affect ABG readings (e.g., lipemic specimens).
- •History of hematological conditions affecting red blood cell morphology (e.g., sickle cell disease)
- •Patients on Venoarterial extracorporeal membrane oxygenation (VA-ECMO), durable left ventricular assist device (LVAD), or Impella.
研究组 & 干预措施
MABOS
Acquisition of pulse oximeter data from the custom pulse oximeter, MABOS. Participants will have their skin-tone measured using a gold-standard spectrophotometer by a member of the study team. After this measurement, the custom pulse oximeter will be placed on a finger by a member of the study team, and will record data for the duration of the study (maximum of 24 hours). At the end of the study, the device will be removed by the study team.
干预措施: MABOS (Device)
结局指标
主要结局
Accuracy of MABOS by Comparing SpO2 Percent Blood Oxygen Saturation to SaO2 Percent Blood Oxygen Saturation Utilizing ARMS Calculation Calculation
时间窗: From enrollment (placement of device) to the end of the study (when 24 hours have elapsed since placement of the device).
Validate the accuracy of the novel MABOS pulse oximeter against the oxygen saturation of arterial blood in critically ill patients across a range of blood oxygen levels. This will be reported as the R-squared value of the regression fitting the raw oximeter data to the gold standard arterial oxygen measurements (SaO2), as well as an Accuracy-Root Mean Square (ARMS) value (unit: %).
次要结局
- MABOS' Epidermal Melanin Estimation Accuracy comparing True Melanin Concentration (arbitrary units) to Estimated Melanin Concentration (arbitrary units) using the RMSE Calculation(From enrollment (placement of device) to the end of the study (when 24 hours have elapsed since placement of the device).)
- Comparable Accuracy between MABOS and existing pulse oximeter devices using ARMS calculation(From enrollment (placement of device) to the end of the study (when 24 hours have elapsed since placement of the device).)