High-flow nasal oxygen versus conventional oxygen for 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 interventional comparison tests high-flow nasal cannula (HFNC) against conventional oxygen therapy (COT) in adults diagnosed with high-altitude pulmonary edema (HAPE) who cannot or will not descend. Eligible participants are 18 or older with symptom onset within seven days of ascent to ≥2500 m and radiographic pulmonary edema; pregnant patients and those needing emergency intubation are excluded. Treatment is delivered at NO.953 Hospital in Xigazê, Tibet, and investigators monitor respiratory support needs and clinical recovery endpoints. The aim is to see if HFNC provides more rapid or effective respiratory stabilization than conventional oxygen in the HAPE setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged 18 years or older;
2. Onset of symptoms related to HAPE (including dyspnea at rest, cough, or exercise intolerance) within 7 days of ascending to high altitude (≥2500m);
3. Diagnosis of HAPE according to the STAR data reporting guidelines, requiring at least two symptoms (dyspnea at rest, cough, weakness/decreased exercise performance, or chest tightness/congestion) and two clinical signs (rales or wheezing in at least one lung field, central cyanosis, tachypnea, or tachycardia);
4. Radiographic evidence of pulmonary edema on chest X-ray or CT;
5. Refusal or inability to undergo immediate descent at the time of presentation;
6. Capability and willingness to provide written informed consent.

Exclusion criteria:

1. Known or clinically confirmed pregnancy;
2. Requirement for emergency intubation (as assessed by the treating clinician) due to cardiac/respiratory arrest, hemodynamic instability, airway compromise, severe hypoxia, or impaired consciousness, etc;
3. Pulmonary edema or hypoxemia resulting from other medical conditions (e.g., cardiogenic pulmonary edema, sepsis, chronic obstructive pulmonary disease (COPD), pneumothorax, massive pleural effusion, chest trauma, etc.);
4. Glasgow Coma Scale (GCS) score ≤ 12;
5. PaCO₂ \> 55 mmHg;
6. Presence of high-altitude cerebral edema;
7. Receipt of any respiratory support therapy (other than conventional oxygen therapy) prior to admission;
8. Presence of any contraindication to conventional or nasal oxygen therapy;
9. Presence of severe medical conditions or abnormal clinical laboratory findings that, in the investigator's judgment, may pose a risk to the patient's safety or interfere with the study's execution and participant completion;
10. Current participation in other clinical trials;
11. Refusal to sign the informed consent form.

Where it's running

• NO.953 Hospital
  Xigazê, Tibet, China Recruiting

Study contacts

• Principal investigator: Ye Fan, Dr. — Department of Respiratory Disease, Xinqiao Hospital, Third Military Medical University, 83 Xinqiao Zhengjie, Shapingba District, ChongQing 400000, China
• Study coordinator: Yiding Li, Dr.
• Email: fygan@163.com
• Phone: +86 13101377031

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Inclisiran vs. Statin for Primary Aldosteronism

  This trial tests whether inclisiran plus amlodipine works differently from a statin-based approach in people with primary aldosteronism and high blood pressure.

  Recruiting Third Military Medical University · Chongqing, Chongqing Municipality · NCT07884955

• Combined EBUS needle aspiration and mediastinal cryobiopsy to diagnose lung cancer spread

  This trial tries adding EBUS-guided mediastinal cryobiopsy to standard EBUS-TBNA to see if it improves diagnosis for adults with suspected mediastinal metastases of lung cancer.

  Recruiting Third Military Medical University · Chongqing, Chongqing Municipality · NCT07488507

• Lubiprostone for slow-transit constipation

  This will test whether lubiprostone helps adults with slow-transit constipation compared with polyethylene glycol.

  Recruiting at 7 sites Phase 3 Third Military Medical University · Bishan, Chongqing Municipality and 19 other locations · NCT07277907

• Spironolactone with antihypertensives for unilateral primary aldosteronism

  This project will try different doses of spironolactone together with usual blood-pressure medicines in adults with lateralized primary aldosteronism who decline surgery to see if it relieves renin suppression and lowers long-term cardiovascular risks.

  Recruiting Third Military Medical University · Chongqing, Chongqing Municipality · NCT07137364

• Ear (auricular) vagus nerve stimulation added to ICU care for sepsis

  This trial will test whether gentle electrical stimulation of the ear (taVNS), given twice daily along with standard intensive care, can reduce inflammation and organ dysfunction in adults with sepsis.

  Recruiting Third Military Medical University · Chongqing · NCT07051694

• Modified transanal drainage tube to prevent anastomotic leaks after rectal cancer surgery

  This trial tests whether placing a modified transanal drainage tube can reduce anastomotic leakage in adults having sphincter-preserving rectal cancer surgery.

  Recruiting Third Military Medical University · Yuzhong, Chongqing Municipality · NCT07036588

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.