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

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Patent ductus arteriosus
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Brief Title

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

Official Title

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

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 Type

Observational

Primary Outcome

difference in PPG or pulmonary saturation between conditions

Condition

Patent Ductus Arteriosus

Intervention

Pulmonary PPG

Study Arms / Comparison Groups

 Healthy adults
Description:  Healthy adults for checking feasibility of Pulmonary PPG

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

120

Start Date

October 2016

Completion Date

July 2017

Primary Completion Date

July 2017

Eligibility Criteria

        Inclusion Criteria:

          -  Hemodynamic stability

        Exclusion Criteria:

          -  hemodynamic instability

Gender

All

Ages

N/A - 60 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, ,

Administrative Informations

NCT ID

NCT02894970

Organization ID

lung photoplethysmography

Responsible Party

Sponsor

Study Sponsor

Shaare Zedek Medical Center

Collaborators

 Israel Science Foundation

Study Sponsor

, ,

Verification Date

August 2016