U-TruSignal SpO2 Testing in Neonates

Study Overview
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Brief Summary
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The purpose of the study is to demonstrate proper function of the U-TruSignal device via clinical performance testing in a neonatal human subject population under standard clinical conditions. A study with human subjects will provide the needed clinical evidence for assessing the accuracy of the pulse oximeter as recommended by the FDA Guidance Document (Pulse Oximeters - Premarket Notification Submissions [50(k)s]: Guidance for Industry and Food and Drug Administration Staff.)

Detailed Description
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The purpose of this study is to collect blood samples from neonates under normal clinical conditions to ensure proper function (clinical performance) with the U-TruSignal device. The study will include both the TruSignal AllFit Sensor and TruSignal Sensitive Sensor. After providing consent, no preparation beyond the investigational site's standard of care is required before study procedures begin. At the start of the procedure, one to two sensors, upon the discretion of the investigator, shall be applied to the subject. The duration of the subject's participation in the study is dependent upon the scheduled routine arterial blood draw and obtaining the maximum of 6 data pairs (3 data pairs per sensor). The Investigator or designated study staff will collect of SpO2 and pulse rate for each study subject. Laboratory results from arterial blood draw will be collected from the hospital's medical records. The description, severity, and device relatedness of any AE or SAE during the study will be recorded.

Official Title
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U-TruSignal SpO2 Testing in Neonates

Conditions
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Pulse Oximetry

Intervention / Treatment
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* Device: SpO2 Sensor application & blood draw


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parents or legally authorized representative (LAR) can understand and provide written informed consent; AND Subjects are < 29 days old, and requiring arterial blood samples per the site's standard of care. Exclusion Criteria: Neonates with injuries, deformities or abnormalities may prevent proper application of the sensor; Neonates with inadequate heart pump function affecting blood circulation caused by identified cardiac or cardiovascular conditions such as patent ductus arteriosus, persistent pulmonary hypertension, septal defects, or congenital heart disease; Neonates with mean arterial blood pressure < 20mmHg; Neonates with congenital diaphragmatic hernia; OR Neonates under High frequency ventilation therapy.

Ages Eligible for Study
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Maximum Age: 29 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SpO2 Sensor Application & Blood draw<br>All subjects will undergo the same study procedures of having their SpO2 levels measured with an external sensor applied to the skin and blood SpO2 level measured | Device: SpO2 Sensor application & blood draw<br>* At the start of the procedure, one to two commercial sensors shall be applied to the subject. Readings will be allowed to stabilize. After at least 10 minutes of data collection, arterial blood will be collected and analyzed blood per hospital's standard procedure. Data collection will continue post blood draw for two minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy Root Mean Square (ARMS) Per Data Pair | Compare observations of Peripheral Capillary Oxygen Saturation (SpO2- measured by the test pulse oximeter system) and Oxygen Saturation of Arterial Blood (SaO2) values (measured by CO-Oximeter analysis of simultaneous drawn arterial blood). | 30 minutes per data pair | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous SpO2 Measurements During Data Collection Interval | The secondary objective of the study was to demonstrate U-TruSignal collects substantially continuous SpO2 measurements during a data collection interval. All time the sensors were worn and data collected across participants were reviewed for invalid data within each data pair. For the data pairs that had moments of invalid data, a calculation was conducted (invalid data/complete data for data pair) to establish percentage of invalid data per sensor. For each sensor type the percentage of invalid data (%) was calculated. Sensor readings were grouped together across participants and are being reported as the total number of invalid readings over the total number of readings for all participants | 30 minutes per data pair |