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

September 4, 2016 updated by: Shaare Zedek Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

120

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 60 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy volunteer adults and children, normal newborns, normal premature newborns and newborns suffering from patent ductus arteriosus and pulmonary hypertension

Description

Inclusion Criteria:

  • Hemodynamic stability

Exclusion Criteria:

  • hemodynamic instability

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy adults
Healthy adults for checking feasibility of Pulmonary PPG
Device: Pulmonary PPG
Five minutes check with a lights source with two wave lengths of infrared and a detector.
Healthy children
Healthy children for checking feasibility of Pulmonary PPG
Device: Pulmonary PPG
Five minutes check with a lights source with two wave lengths of infrared and a detector.
Healthy neonates
Healthy neonates for checking feasibility of Pulmonary PPG and in order to be a control group for neonates with pulmonary hypertension.
Device: Pulmonary PPG
Five minutes check with a lights source with two wave lengths of infrared and a detector.
Healthy preterm neonates
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
Five minutes check with a lights source with two wave lengths of infrared and a detector.
Preterm neonates with PDA
Preterm neonates with hemodynamic significant PDA. Intervention: evaluate Pulmonary PPG and oxygen saturation as compared to normal newborns.
Device: Pulmonary PPG
Five minutes check with a lights source with two wave lengths of infrared and a detector.
Neonates with pulmonary hypertension
Neonates with pulmonary hypertension. Intervention: evaluate Pulmonary PPG and oxygen saturation as compared to normal newborns.
Device: Pulmonary PPG
Five minutes check with a lights source with two wave lengths of infrared and a detector.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
difference in PPG or pulmonary saturation between conditions
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaare Zedek Medical Center

Collaborators

Israel Science Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

August 25, 2016

First Submitted That Met QC Criteria

September 4, 2016

First Posted (Estimate)

September 9, 2016

Study Record Updates

Last Update Posted (Estimate)

September 9, 2016

Last Update Submitted That Met QC Criteria

September 4, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • lung photoplethysmography

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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