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

Shaare Zedek Medical Center

Status: Unknown

Conditions: Pulmonary Hypertension; Patent Ductus Arteriosus

Treatments: Device: Pulmonary PPG

Study type: Observational

Funder types: Other

Identifiers

NCT02894970

lung photoplethysmography

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 1 day to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Hemodynamic stability

Exclusion criteria

• hemodynamic instability

Trial design

120 participants in 6 patient groups

Healthy adults

Description:

Healthy adults for checking feasibility of Pulmonary PPG

Treatment:

Device: Pulmonary PPG

Healthy children

Description:

Healthy children for checking feasibility of Pulmonary PPG

Treatment:

Device: Pulmonary PPG

Healthy neonates

Description:

Healthy neonates for checking feasibility of Pulmonary PPG and in order to be a control group for neonates with pulmonary hypertension.

Treatment:

Device: Pulmonary PPG

Healthy preterm neonates

Description:

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).

Treatment:

Device: Pulmonary PPG

Preterm neonates with PDA

Description:

Preterm neonates with hemodynamic significant PDA. Intervention: evaluate Pulmonary PPG and oxygen saturation as compared to normal newborns.

Treatment:

Device: Pulmonary PPG

Neonates with pulmonary hypertension

Description:

Neonates with pulmonary hypertension. Intervention: evaluate Pulmonary PPG and oxygen saturation as compared to normal newborns.

Treatment:

Device: Pulmonary PPG