Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06852924

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

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Tibet Fokang Hospital

Lhasa, Tibet, China

Actively Recruiting

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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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