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

• Conditions: Patent Ductus Arteriosus; Pulmonary Hypertension
• Interventions: Device: Pulmonary PPG

• Registration Number: NCT02894970
• Lead Sponsor: Shaare Zedek Medical Center

Brief Summary

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

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.

Study Timeline

• Status Verified: 2016-08
• Study First Submitted: 2016-08-25
• Study First Submitted QC: 2016-09-04
• Last Update Submitted: 2016-09-04
• Study First Posted: 2016-09-09
• Last Update Posted: 2016-09-09
• Study Start: 2016-10
• Primary Completion: 2017-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Hemodynamic stability

Exclusion Criteria

• hemodynamic instability

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy children	Pulmonary PPG	Healthy children for checking feasibility of Pulmonary PPG
Healthy adults	Pulmonary PPG	Healthy adults for checking feasibility of Pulmonary PPG
Healthy neonates	Pulmonary PPG	Healthy neonates for checking feasibility of Pulmonary PPG and in order to be a control group for neonates with pulmonary hypertension.
Healthy preterm neonates	Pulmonary PPG	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).
Neonates with pulmonary hypertension	Pulmonary PPG	Neonates with pulmonary hypertension. Intervention: evaluate Pulmonary PPG and oxygen saturation as compared to normal newborns.
Preterm neonates with PDA	Pulmonary PPG	Preterm neonates with hemodynamic significant PDA. Intervention: evaluate Pulmonary PPG and oxygen saturation as compared to normal newborns.

Primary Outcome Measures

Name	Time	Method
difference in PPG or pulmonary saturation between conditions	1 year