Using inhaled nitric oxide to treat high altitude pulmonary edema

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This investigation evaluates the effectiveness of inhaled nitric oxide (iNO) in managing mild to moderate high altitude pulmonary edema (HAPE). The study employs a novel nitric oxide therapeutic device that generates and delivers nitric oxide gas in real-time, ensuring precise administration and monitoring of gas concentrations. Participants will be assessed on various parameters, including changes in oxygenation, symptom resolution, and imaging indicators over a treatment period of 3 to 7 days. The study aims to compare outcomes between those receiving iNO and a control group.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Individuals aged between 18 and 65 years.
2. A score on the Lake Louise Acute Mountain Sickness Scale ranging from 3 to 9 points, as outlined in Annex 2, recorded in 2018.
3. 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.
4. Capacity to provide informed consent in accordance with local regulatory requirements.

Exclusion Criteria:

1. Confirmed contraindications for the use of nitric oxide include the following (refer to "5.3.4 NO Contraindications"):

   * 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.
2. Severe left ventricular dysfunction, characterized by a left ventricular ejection fraction (LVEF) of less than 40%.
3. Pulmonary edema resulting from other cardiac, pulmonary, thoracic, or systemic disorders.
4. Coexistence with high altitude cerebral edema.
5. A history of lung malignancy, lung resection, or lung transplantation.
6. Barotrauma, which may include pneumothorax, subcutaneous and mediastinal emphysema, or the presence of a closed drainage tube in the thoracic cavity.
7. Clinically significant or persistent thrombocytopenia, defined as a platelet count of less than 50×10\^9/L.
8. Administration of pulmonary hypertension medications, such as sildenafil, bosentan, or prostacyclins, within the preceding 30 days.
9. Noncompliance with study protocols and unwillingness to provide informed consent.
10. Any other conditions that the clinician deems render the subject unsuitable for participation in the study.

Where it's running

• Tibet Fokang Hospital
  Lhasa, Tibet, China Recruiting

Study contacts

• Principal investigator: Jingxin Cao — Tibet Fokind Hospital
• Study coordinator: Zhou Fang
• Email: zhou.fang@novlead.com
• Phone: 15655595707

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.