Evaluation of Accuracy of the Owlet OSS 3.0 Sensor in the Neonatal Population
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Pulse oximetry Accuracy - Root Mean Square
研究概览
简要总结
The sponsor of this study, Owlet Baby Care, Inc., is comparing the accuracy of their pulse oximeter Sensor with the measurements of oxygen levels in newborns who are already being monitored with arterial blood samples. A minimum of 20, but up to 100 participants will be enrolled in a hospital environment and need to weigh 1500 grams or more. The purpose of the testing is to gather information on pulse oximeter readings taken by the Owlet OSS 3.0 Sensor and compare the readings to blood gas samples drawn by the medical staff. This will determine if the Owlet Sensor is accurate in newborns up to an age of 28 days after actual or expected delivery date.
The Owlet OSS 3.0 is the Sensor component within the Owlet Dream Sock, an over the counter, noninvasive pulse oximeter which is currently FDA cleared in infants 1-18 months and between 6 and 30lbs, meant to be used in the home environment. The Owlet Sock is a fabric wrap that secures the Sensor to a baby's foot. The Sensor estimates the baby's SpO2, pulse rate, and measures movement level, and transmits the wearer's readings to the paired Base Station via low energy BlueTooth energy.
详细描述
This is a prospective, non-randomized, single arm study to evaluate SpO2 performance of the Owlet OSS 3.0 pulse oximetry Sensor in the neonate population up to 44 weeks corrected gestational age using convenience sampling of arterial blood gas samples as a part of routine clinical monitoring.
The Owlet OSS 3.0 Sensor is the component of the Owlet Dream Sock (DEN220091) and BabySat (K222597), both Food and Drug Administration (FDA) cleared pulse oximeters for infants 1-18 months in 2023. This component performs the signal acquisition and analysis to estimate pulse rate and SpO2 readings.
The study will enroll between 20-100 neonates weighing a minimum of 1500g in the hospital setting with available arterial line access and arterial blood gas samples being performed as part of planned patient management. No additional blood gas samples will be taken beyond clinical care indications.
The primary outcome of the study is the accuracy of the Owlet OSS 3.0 Sensor SpO2 readings compared to simultaneous arterial saturation (SaO2) measurements from arterial blood gas samples as determined by a root mean square (ARMS) calculation.
Secondary outcomes will include:
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
- 0 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Less than or equal to 44 weeks corrected gestational age
- •Weight equal or greater than 1500g
- •Subjects with standard of care (SOC) arterial blood sampling line already in place at time of enrollment, with anticipated arterial blood gas measurements as part of their plan of care
排除标准
- •Subjects with underdeveloped skin as assessed by a study investigator and/or reported by the clinical care team
- •Subjects with abnormalities (e.g., limb deformities, open wounds, severe edema) at the planned application sites that would interfere with system measurements
- •Potential subjects on extracorporeal membrane oxygenation (ECMO) or other mechanical circulatory support
- •Arterial line is placed in a preductal position with the potential of pulmonary to systemic shunting
- •Subjects undergoing cooling protocol/therapeutic hypothermia
- •Subjects who are deemed too clinically unstable by the Principal Investigator (PI), sub-investigator and/or clinical care team to participate in the study.
结局指标
主要结局
Pulse oximetry Accuracy - Root Mean Square
时间窗: 48 hours
Accuracy of the Owlet OSS 3.0 Sensor SpO2 readings compared to simultaneous arterial saturation (SaO2) measurements from arterial blood gas samples as determined by a root mean square (ARMS) calculation.
次要结局
- Pulse oximetry Accuracy - Bias(48 hours)
- Pulse oximetry Accuracy - Precision(48 hours)