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
• 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

• Ductus Arteriosus, Patent
• Hypertension, Pulmonary
• Patent Ductus Arteriosus
• Pulmonary Hypertension

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