Patent Ductus ArteriosusNCT02894970
A New Device for Measuring of Lung Photoplethysmography and Pulmonic Arterial Saturation
An observational study of Patent Ductus Arteriosus and Pulmonary Hypertension, run by Shaare Zedek Medical Center.
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. Read more about this study
- Who is it for?
- Ages 1 day to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Patent Ductus Arteriosus, Pulmonary Hypertension
- What is being tested?
- Pulmonary PPG
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Healthy volunteer adults and children, normal newborns, normal premature newborns and newborns suffering from patent ductus arteriosus and pulmonary hypertension
Who may be able to join
- Hemodynamic stability
Who cannot join
- hemodynamic instability
About this study
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.
Read the 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.
- Conditions
- Patent Ductus Arteriosus, Pulmonary Hypertension
- Being tested
- Pulmonary PPG
- Medical subject headings
- Ductus Arteriosus, Patent, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary PPGDevice
Five minutes check with a lights source with two wave lengths of infrared and a detector.
| Study group | Role | What they receive |
|---|---|---|
| Healthy adults | Healthy adults for checking feasibility of Pulmonary PPG Receives: Device: Pulmonary PPG | |
| Healthy children | Healthy children for checking feasibility of Pulmonary PPG Receives: Device: Pulmonary PPG | |
| Healthy neonates | Healthy neonates for checking feasibility of Pulmonary PPG and in order to be a control group for neonates with pulmonary hypertension. Receives: Device: Pulmonary PPG | |
| 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). Receives: Device: Pulmonary PPG | |
| Preterm neonates with PDA | Preterm neonates with hemodynamic significant PDA. Intervention: evaluate Pulmonary PPG and oxygen saturation as compared to normal newborns. Receives: Device: Pulmonary PPG | |
| Neonates with pulmonary hypertension | Neonates with pulmonary hypertension. Intervention: evaluate Pulmonary PPG and oxygen saturation as compared to normal newborns. Receives: Device: Pulmonary PPG |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in PPG or pulmonary saturation between conditions
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patent Ductus ArteriosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Israel Science Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894970
- Sponsor's protocol ID
- lung photoplethysmography
- Status last verified
- Aug 2016
- First submitted
- 25 Aug 2016
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 23679994
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Device for Measuring of Lung Photoplethysmography and Pulmonic Arterial Saturation
- ClinicalTrials.gov ID
- NCT02894970
- Acronym / sponsor ID
- lung photoplethysmography
- Conditions
- Patent Ductus Arteriosus, Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Collaborators
- Israel Science Foundation
- Study start
- Oct 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Healthy adults | – | Device: Pulmonary PPGHealthy adults for checking feasibility of Pulmonary PPG |
| Healthy children | – | Device: Pulmonary PPGHealthy children for checking feasibility of Pulmonary PPG |
| Healthy neonates | – | Device: Pulmonary PPGHealthy neonates for checking feasibility of Pulmonary PPG and in order to be a control group for neonates with pulmonary hypertension. |
| Healthy preterm neonates | – | Device: Pulmonary PPGHealthy preterm neonates for checking feasibility of Pulmonary PPG and in order to be a control group for premature neonates with patent ductus arteriosus (PDA). |
| Preterm neonates with PDA | – | Device: Pulmonary PPGPreterm neonates with hemodynamic significant PDA. Intervention: evaluate Pulmonary PPG and oxygen saturation as compared to normal newborns. |
| Neonates with pulmonary hypertension | – | Device: Pulmonary PPGNeonates with pulmonary hypertension. Intervention: evaluate Pulmonary PPG and oxygen saturation as compared to normal newborns. |
Who may qualify
- Ages
- 1 day to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Healthy volunteer adults and children, normal newborns, normal premature newborns and newborns suffering from patent ductus arteriosus and pulmonary hypertension
Key inclusion criteria (1 listed)
- Hemodynamic stability
Key exclusion criteria (1 listed)
- hemodynamic instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary PPGFive minutes check with a lights source with two wave lengths of infrared and a detector. | Device | Healthy adults, Healthy children, Healthy neonates, Healthy preterm neonates, Neonates with pulmonary hypertension, Preterm neonates with PDA |
Primary outcome
difference in PPG or pulmonary saturation between conditions
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
- Background: PubMed 23679994Nitzan 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Patent Ductus Arteriosus and Pulmonary Hypertension, run by Shaare Zedek Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in PPG or pulmonary saturation between conditions (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02894970, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2016.