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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
Sponsor:
Information provided by (Responsible Party):
Lorenzo Berra, MD, Massachusetts General Hospital

Brief Summary:

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

Detailed Description:

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:

  1. HEALTHY volunteer study, and
  2. 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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Oxygenation [ Time Frame: 20 minutes ]
    Percent change in oxygen saturation (HbO2/totHb)

  2. Methemoglobin [ Time Frame: 20 minutes ]
    Percent change in methemoglobin levels (metHb/totHb)

  3. Carboxyhemoglobin [ Time Frame: 20 minutes ]
    Percent change in carboxyhemoglobin levels (COHb/totHb)


Secondary Outcome Measures :
  1. Pulmonary artery pressure [ Time Frame: 20 minutes ]
    Change in pulmonary artery pressure (mmHg)

  2. Cyclic guanosine monophosphate [ Time Frame: 20 minutes ]
    Percent change in plasma cyclic guanosine monophosphate (measured over baseline)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

FIRST PART OF THE STUDY: HEALTHY VOLUNTEER STUDY (n=6 volunteers)

Inclusion Criteria:

  • Have a government photo identity card;
  • Age < 40 years old;
  • Body mass index (BMI) <28 kg/m2 and >18 kg/m2;
  • Feel well the day of nitric oxide testing;
  • Normal physical exam

Exclusion Criteria:

  • Psychiatric disturbances such as anxiety, depression, schizophrenia requiring pharmacological treatment or hospitalization in the last year;
  • Systemic disease with or without any functional limitation; including controlled hypertension and controlled diabetes without systemic effects;
  • Pregnancy determined by urine pregnancy test, detecting presence of human chorionic gonadotropin, or less than six weeks postpartum;
  • Active smoking, volunteers may be enrolled if they quit smoking for more than 1 year;
  • Excess alcohol use: more than ½ L/day of wine consumption or equivalent;
  • Any current use of a medication other than: Over-the-counter oral medications, herbal remedies, nutritional supplements, and oral contraceptives;
  • Currently enrolled in another research study.

SECOND PART OF THE STUDY: CATH-LABORATORY STUDY (n=6 cath laboratory subjects)

Inclusion criteria:

  • Have a government photo identity card;
  • Diagnosis of Pulmonary Arterial Hypertension, Group I, III, IV and V, as defined by the National Heart Lung and Blood Institute classification.
  • Known positive responder to inhaled nitric oxide
  • Wedge pressure ≤15 mmHg at baseline
  • Pulmonary arterial pressure (mean) greater than or equal to 40 mmHg
  • Scheduled Cath Lab testing for right heart catheterization to assess pulmonary vasodilator capacity

Exclusion Criteria:

  • Psychiatric disturbances such as anxiety, depression, schizophrenia requiring pharmacological treatment or hospitalization in the last year;
  • Pregnancy determined by urine pregnancy test, detecting presence of human chorionic gonadotropin, or less than six weeks postpartum;
  • Left ventricular failure for which breathing nitric oxide is contraindicated;
  • Patients with diagnosis of congenital or acquired methemoglobinemia reductase deficiency;
  • Currently enrolled in another research study.

Information from the National Library of Medicine

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


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Lorenzo Berra, MD MGH
Additional Information:
Publications:
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Responsible Party: Lorenzo Berra, MD, Anesthesiologist and Intensivist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02305550    
Other Study ID Numbers: eNO for inhalation
First Posted: December 2, 2014    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Keywords provided by Lorenzo Berra, MD, Massachusetts General Hospital:
Nitric Oxide
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Respiratory Tract Diseases
Lung Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents