Actively Recruiting
Inhaled Nitric Oxide for High Amplitude Pulmonary Edema (HAPE)
Led by Novlead Inc. · Updated on 2025-02-28
100
Participants Needed
1
Research Sites
124 weeks
Total Duration
On this page
Sponsors
N
Novlead Inc.
Lead Sponsor
T
Tibet Fokind Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
High Altitude Pulmonary Edema (HAPE) is a critical, non-cardiogenic pulmonary edema that manifests in high-altitude conditions, marked by the rapid onset of symptoms such as dyspnea, cough, frothy sputum, and cyanosis. It represents a significant cause of mortality among high-altitude illnesses due to its swift progression and elevated fatality rates if not addressed promptly. The pathophysiological mechanisms underlying HAPE include excessive hypoxic pulmonary vasoconstriction, increased permeability of the pulmonary vasculature, impaired clearance of fluid from the lungs, and systemic fluid retention. A pivotal factor in HAPE is pulmonary arterial hypertension (PAH), characterized by a progressive rise in pulmonary arterial pressure and resistance, which can ultimately lead to right heart failure. Recent developments in the management of HAPE have introduced inhaled nitric oxide (iNO) as a selective pulmonary vasodilator, which effectively lowers pulmonary arterial pressure and enhances oxygenation without inducing systemic hypotension. The INOwill N300 device, created by Nanjing Novlead Biotech, is a portable iNO delivery system that produces nitric oxide gas on-site, thereby obviating the need for gas cylinders. This device also facilitates real-time monitoring of nitric oxide, nitrogen dioxide, and oxygen concentrations, ensuring safe and effective treatment. This innovative strategy shows potential for improving clinical outcomes in patients with HAPE while addressing logistical challenges encountered in high-altitude environments.
CONDITIONS
Official Title
Inhaled Nitric Oxide for High Amplitude Pulmonary Edema (HAPE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals aged between 18 and 65 years.
- Lake Louise Acute Mountain Sickness Scale score between 3 and 9 points.
- Chest X-ray showing thickening of lung texture on both sides or nodular opacities in lower lung regions.
- Ability to provide informed consent as per local regulations.
You will not qualify if you...
- Severe heart or lung conditions including left heart hypoplasia, duct-dependent congenital heart disease, life-threatening congenital anomalies, congestive heart failure, and congenital methemoglobinemia.
- Severe bleeding disorders such as intracranial, intraventricular, or pulmonary hemorrhage.
- Left ventricular ejection fraction below 40%.
- Pulmonary edema caused by other heart, lung, chest, or systemic diseases.
- Presence of high altitude cerebral edema.
- History of lung cancer, lung surgery, or lung transplant.
- Barotrauma including pneumothorax, subcutaneous or mediastinal emphysema, or chest drainage tubes.
- Significant or persistent low platelet count (below 50 x 10^9/L).
- Use of pulmonary hypertension drugs like sildenafil, bosentan, or prostacyclins within 30 days before the study.
- Noncompliance with study protocols or unwillingness to consent.
- Any other condition deemed unsuitable by the clinician.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tibet Fokang Hospital
Lhasa, Tibet, China
Actively Recruiting
Research Team
Z
Zhou Fang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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