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NCT02894970 Clinical Trial

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

Pulmonary Hypertension Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02894970
Other study ID # lung photoplethysmography
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 25, 2016
Last updated September 4, 2016
Start date October 2016
Est. completion date July 2017

Study information
Verified date August 2016
Source Shaare Zedek Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 120
Est. completion date July 2017
Est. primary completion date July 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 60 Years
Eligibility Inclusion Criteria:

- Hemodynamic stability

Exclusion Criteria:

- hemodynamic instability

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• Pulmonary PPG
Five minutes check with a lights source with two wave lengths of infrared and a detector.

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Shaare Zedek Medical Center Israel Science Foundation

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary difference in PPG or pulmonary saturation between conditions 1 year No
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