RecruitingNot ApplicableNCT06852924

Inhaled Nitric Oxide for High Amplitude Pulmonary Edema (HAPE)

A Single-center Prospective Randomized Controlled Trial of Inhaled Nitric Oxide in the Treatment of High Amplitude Pulmonary Edema(HAPE)


Sponsor

Novlead Inc.

Enrollment

100 participants

Start Date

Aug 10, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether breathing inhaled nitric oxide gas can treat high-altitude pulmonary edema (HAPE) — a dangerous condition where fluid builds up in the lungs when climbing to high elevations too quickly. **You may be eligible if:** - You are between 18 and 65 years old - You are at high altitude and have moderate altitude sickness symptoms (Lake Louise score of 3–9) - A chest X-ray shows fluid or abnormal changes in your lungs - You are able to give informed consent **You may NOT be eligible if:** - You have serious heart conditions (e.g., severe heart failure, certain congenital heart defects) - Your fluid in the lungs is caused by a heart or lung condition unrelated to altitude - You also have high-altitude brain swelling (cerebral edema) - You have a history of lung cancer, lung surgery, or lung transplant - You have a collapsed lung (pneumothorax) - You have very low platelet counts - You have recently taken medications for pulmonary hypertension (e.g., sildenafil) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENitric Oxide Generation and Delivery System

The Nitric Oxide Generation and Delivery System is used to deliver nitric oxide for inhalation therapy into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath.


Locations(1)

Tibet Fokang Hospital

Lhasa, Tibet, China

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NCT06852924