A Proof of Concept Study of Electrical Discharge Produced Nitric Oxide for Inhalation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02305550|
Recruitment Status : Completed
First Posted : December 2, 2014
Last Update Posted : February 10, 2017
Study Design: This is a two-part physiological for a device feasibility. Both studies are proof of concept descriptive pilot studies.
The FIRST PART is a study of healthy volunteers and the SECOND PART of patients with pulmonary hypertension at routine cardiac catheterization laboratory (CATH-LABORATORY).
Volunteers and patients will be enrolled sequentially; there is no group randomization.
Overall hypothesis of this device feasibility study: To test a lightweight and portable method of synthesizing therapeutic levels of inhaled nitric oxide from air by electrical pulsed discharge.
|Condition or disease||Intervention/treatment||Phase|
|Hypertension, Pulmonary||Device: electrical pulsed plasma discharge synthesis of nitric oxide||Not Applicable|
Background. Inhaled nitric oxide is routinely used to treat acute pulmonary hypertension in infants, children and adults. By 2014 it has been estimate about 500,000 US patients have been treated with nitric oxide, with only the rare complication of methemoglobinemia reported at high inhaled doses.
Rationale. The investigators explored novel alternative lightweight and economical methods of local nitric oxide production. In particular the investigators synthesized nitric oxide from air by an electrical pulsed plasma discharge. After 2 years of study the investigators have designed and produced a prototype of a device synthesizing nitric oxide from air with low levels of nitrogen dioxide and ozone. After completing experimentation in lambs, the investigators now plan to study nitric oxide generators in a proof of concept clinical study.
Design of the study: The study is comprised of two parts:
- HEALTHY volunteer study, and
- CATH-LABORATORY study in patients.
The study will be conducted at low levels of breathing nitric oxide, 25 parts per million of nitric oxide, for 20 minutes to comply with the threshold of the Environmental Protection Agency (EPA) for daily work exposure.
The first portion of the study will be carried out in 6 healthy volunteers breathing 25 parts per million of nitric oxide. After this first part, the investigators will proceed to the second portion of the study and enroll 6 patients with pulmonary hypertension undergoing scheduled testing with a nitric oxide-pulmonary vasodilator response (CATH-LABORATORY study).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||A Proof of Concept Study of Electrical Discharge Produced Nitric Oxide for Inhalation|
|Study Start Date :||April 2015|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Experimental: electrical synthesis nitric oxide
Participants will breath 20 minutes of electrical pulsed plasma discharge synthesis of nitric oxide at 25 parts per million
Device: electrical pulsed plasma discharge synthesis of nitric oxide
An NO generator was designed and developed by electrical pulsed plasma discharge nitric oxide from atmospheric nitrogen and oxygen. This generator has been fabricated by the investigators and it is not commercially available.
- Oxygenation [ Time Frame: 20 minutes ]Percent change in oxygen saturation (HbO2/totHb)
- Methemoglobin [ Time Frame: 20 minutes ]Percent change in methemoglobin levels (metHb/totHb)
- Carboxyhemoglobin [ Time Frame: 20 minutes ]Percent change in carboxyhemoglobin levels (COHb/totHb)
- Pulmonary artery pressure [ Time Frame: 20 minutes ]Change in pulmonary artery pressure (mmHg)
- Cyclic guanosine monophosphate [ Time Frame: 20 minutes ]Percent change in plasma cyclic guanosine monophosphate (measured over baseline)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02305550
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Lorenzo Berra, MD||MGH|