A New Device for Measuring of Lung Photoplethysmography and Pulmonic Arterial Saturation

Study Overview
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Brief Summary
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To evaluate feasibility of photoplethysmography (PPG) of pulmonary arteries in adults children and neonates and to compare normal controls to premature newborns suffering from patent ductus arteriosus and neonates suffering from pulmonary hypertension.

Detailed Description
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This study aims to check a new device for measuring lung photoplethysmography (PPG) of pulmonary arteries by delivering light through the chest wall. The aim is to evaluate pulmonary arteries' elasticity and oxygen saturation. We will study adults children and neonates. We will study 20 healthy adults, 20 healthy children aged 2-8 years, twenty healthy neonates, 20 preterm neonates with patent ductus arteriosus (PDA) and 20 preterm neonates with no PDA. We will study also 20 neonates with pulmonary hypertension. Each participant will be examined for 5 minutes and PPG signal will be recorded in a computer and evaluated offline later on. Pulmonic saturation will be calculated from absorption difference between two wave lengths of infrared light that will be used. Our hypothesis is that the mentioned clinical conditions will affect PPG signal and pulmonary arterial oxygen saturation.

Official Title
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A New Device for Measuring of Lung Photoplethysmography and Pulmonic Arterial Saturation

Conditions
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Patent Ductus Arteriosus, Pulmonary Hypertension

Intervention / Treatment
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* Device: Pulmonary PPG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hemodynamic stability Exclusion Criteria: hemodynamic instability

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy adults<br>Healthy adults for checking feasibility of Pulmonary PPG | Device: Pulmonary PPG<br>* Five minutes check with a lights source with two wave lengths of infrared and a detector.<br>|
| Healthy children<br>Healthy children for checking feasibility of Pulmonary PPG | Device: Pulmonary PPG<br>* Five minutes check with a lights source with two wave lengths of infrared and a detector.<br>|
| Healthy neonates<br>Healthy neonates for checking feasibility of Pulmonary PPG and in order to be a control group for neonates with pulmonary hypertension. | Device: Pulmonary PPG<br>* Five minutes check with a lights source with two wave lengths of infrared and a detector.<br>|
| Healthy preterm neonates<br>Healthy preterm neonates for checking feasibility of Pulmonary PPG and in order to be a control group for premature neonates with patent ductus arteriosus (PDA). | Device: Pulmonary PPG<br>* Five minutes check with a lights source with two wave lengths of infrared and a detector.<br>|
| Preterm neonates with PDA<br>Preterm neonates with hemodynamic significant PDA. Intervention: evaluate Pulmonary PPG and oxygen saturation as compared to normal newborns. | Device: Pulmonary PPG<br>* Five minutes check with a lights source with two wave lengths of infrared and a detector.<br>|
| Neonates with pulmonary hypertension<br>Neonates with pulmonary hypertension. Intervention: evaluate Pulmonary PPG and oxygen saturation as compared to normal newborns. | Device: Pulmonary PPG<br>* Five minutes check with a lights source with two wave lengths of infrared and a detector.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in PPG or pulmonary saturation between conditions |  | 1 year |