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

NCT ID: NCT02894970

Last Updated: 2016-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-07-31

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.

Conditions

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Patent Ductus Arteriosus Pulmonary Hypertension

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy adults

Healthy adults for checking feasibility of Pulmonary PPG

Pulmonary PPG

Intervention Type DEVICE

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

Pulmonary PPG

Intervention Type DEVICE

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.

Pulmonary PPG

Intervention Type DEVICE

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).

Pulmonary PPG

Intervention Type DEVICE

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.

Pulmonary PPG

Intervention Type DEVICE

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.

Pulmonary PPG

Intervention Type DEVICE

Five minutes check with a lights source with two wave lengths of infrared and a detector.

Interventions

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Pulmonary PPG

Five minutes check with a lights source with two wave lengths of infrared and a detector.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Hemodynamic stability

Exclusion Criteria

* hemodynamic instability
Minimum Eligible Age

1 Day

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Israel Science Foundation

OTHER

Sponsor Role collaborator

Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Nitzan M, Nitzan I. Pulse oximetry in the pulmonary tissue for the non-invasive measurement of mixed venous oxygen saturation. Med Hypotheses. 2013 Aug;81(2):293-6. doi: 10.1016/j.mehy.2013.04.026. Epub 2013 May 13.

Reference Type BACKGROUND
PMID: 23679994 (View on PubMed)

Other Identifiers

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lung photoplethysmography

Identifier Type: -

Identifier Source: org_study_id

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