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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Individuals aged between 18 and 65 years.

• A score on the Lake Louise Acute Mountain Sickness Scale ranging from 3 to 9 points, as outlined in Annex 2, recorded in 2018.

• Chest X-ray findings that demonstrate either thickening of the lung texture bilaterally or the presence of nodular opacities in the lower regions of both lungs.

• Capacity to provide informed consent in accordance with local regulatory requirements.

Locations
Other Locations
China
Tibet Fokang Hospital
RECRUITING
Lhasa
Contact Information
Primary
Zhou Fang
zhou.fang@novlead.com
15655595707
Time Frame
Start Date: 2023-08-10
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 100
Treatments
No_intervention: Control group: Received traditional treatment
Control group: received traditional treatment, intravenous injection of furosemide, aminophylline, dexamethasone, oxygen inhalation, and other symptomatic treatment drugs.
Experimental: Inhaled Nitric Oxide (iNO) - Group A
On the basis of traditional treatment, NO 15 ppm was inhaled 30min/ time, twice/day, once in the morning and once in the afternoon.
Experimental: Inhaled Nitric Oxide (iNO)-Group B
On the basis of traditional treatment, NO 15 ppm was inhaled 2h/ time, twice/day, once in the morning and once in the afternoon.
Sponsors
Collaborators: Tibet Fokind Hospital
Leads: Novlead Inc.

This content was sourced from clinicaltrials.gov