A Proof of Concept Study of Electrical Discharge Produced Nitric Oxide for Inhalation

NCT02305550 | Completed

• 1 other identifier: eNO for inhalation
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension, Pulmonary

Keywords

Nitric Oxide

Outcome Measures

Primary Outcomes (3)

• Oxygenation

  Percent change in oxygen saturation (HbO2/totHb)

  20 minutes

• Methemoglobin

  Percent change in methemoglobin levels (metHb/totHb)

  20 minutes

• Carboxyhemoglobin

  Percent change in carboxyhemoglobin levels (COHb/totHb)

  20 minutes

Secondary Outcomes (2)

• Pulmonary artery pressure

  20 minutes

• Cyclic guanosine monophosphate

  20 minutes

Study Arms (1)

electrical synthesis nitric oxide

EXPERIMENTAL

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

Interventions

electrical pulsed plasma discharge synthesis of nitric oxide DEVICE

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.

electrical synthesis nitric oxide

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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
• Psychiatric disturbances such as anxiety, depression, schizophrenia requiring pharmacological treatment or hospitalization in the last year;

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

• Malhotra R, Hess D, Lewis GD, Bloch KD, Waxman AB, Semigran MJ. Vasoreactivity to inhaled nitric oxide with oxygen predicts long-term survival in pulmonary arterial hypertension. Pulm Circ. 2011 Apr;1(2):250-258. doi: 10.4103/2045-8932.83449.

  PMID: 22020367 BACKGROUND

• Frostell C, Fratacci MD, Wain JC, Jones R, Zapol WM. Inhaled nitric oxide. A selective pulmonary vasodilator reversing hypoxic pulmonary vasoconstriction. Circulation. 1991 Jun;83(6):2038-47. doi: 10.1161/01.cir.83.6.2038.

  PMID: 2040056 BACKGROUND

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Lorenzo Berra, MD

  MGH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist and Intensivist

Study Record Dates

• First Submitted: November 21, 2014
• First Posted: December 2, 2014
• Study Start: April 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: February 10, 2017

Record last verified: 2017-02

Locations

US (1)