Inhaled Nitric Oxide for High Amplitude Pulmonary Edema (HAPE)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNovlead Inc.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Severe hypoplasia of the left heart or duct-dependent congenital heart disease;

Life-threatening congenital anomalies and congestive heart failure;

Congenital methemoglobinemia;

Severe hemorrhagic conditions, including intracranial hemorrhage, intraventricular hemorrhage, and pulmonary hemorrhage.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nitric Oxide Generation and Delivery System

    Device

    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.

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: Control group: Received traditional treatmentNo intervention 0 interventions
Group B: Inhaled Nitric Oxide (iNO) - Group AExperimental treatment 1 intervention
Group C: Inhaled Nitric Oxide (iNO)-Group BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change of Oxygen Index

The change of oxygenation index (PaO2 or SpO2/FiO2) from baseline, and the time required for oxygenation index to improve by ≥20%

Time frame
Through study completion, an average of 5 days

Secondary outcomes

1

Progression of HAPE

The proportion and time of HAPE cured, markedly effective, ineffective, or severe

Time frame
Through study completion, an average of 5 days
2

Symptoms Improvement

Change of symptom improvement (Lake Louise AMS score, vital signs, imagings)

Time frame
Through study completion, an average of 5 days
3

Hospital Stays

The length of hospital stay compared between groups

Time frame
Through study completion, an average of 5 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novlead Inc.

Lead sponsor

Tibet Fokind Hospital

Collaborator