A Proof of Concept Study of Electrical Discharge Produced Nitric Oxide for Inhalation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Oxygenation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
electrical synthesis nitric oxide
Participants will breath 20 minutes of electrical pulsed plasma discharge synthesis of nitric oxide at 25 parts per million
干预措施: electrical pulsed plasma discharge synthesis of nitric oxide (Device)
结局指标
主要结局
Oxygenation
时间窗: 20 minutes
Percent change in oxygen saturation (HbO2/totHb)
Methemoglobin
时间窗: 20 minutes
Percent change in methemoglobin levels (metHb/totHb)
Carboxyhemoglobin
时间窗: 20 minutes
Percent change in carboxyhemoglobin levels (COHb/totHb)
次要结局
- Pulmonary artery pressure(20 minutes)
- Cyclic guanosine monophosphate(20 minutes)
研究者
Lorenzo Berra, MD
Anesthesiologist and Intensivist
Massachusetts General Hospital