U-TruSignal SpO2 Testing in Neonates

General Electric (GE)

Status: Completed

Conditions: Pulse Oximetry

Treatments: Device: SpO2 Sensor application & blood draw

Study type: Interventional

Funder types: Industry

Identifiers

NCT03383757

123.04-2017-GES-0002

Details and patient eligibility

About

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.)

Full description

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.

Enrollment: 117 patients

Sex: All

Ages: Under 29 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Parents or legally authorized representative (LAR) can understand and provide written informed consent; AND
2. Subjects are < 29 days old, and requiring arterial blood samples per the site's standard of care.

Exclusion criteria

1. Neonates with injuries, deformities or abnormalities may prevent proper application of the sensor;
2. 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;
3. Neonates with mean arterial blood pressure < 20mmHg;
4. Neonates with congenital diaphragmatic hernia; OR
5. Neonates under High frequency ventilation therapy.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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117 participants in 1 patient group

SpO2 Sensor Application & Blood draw

Experimental group

Description:

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

Treatment:

Device: SpO2 Sensor application & blood draw