High-altitude Pulmonary Edema
Conditions
Keywords
HAPE
Brief summary
This study aims to evaluate whether High-flow Nasal Cannula Oxygen Therapy (HFNC) provides superior respiratory support compared to Conventional Oxygen Therapy (COT) in patients with High-Altitude Pulmonary Edema (HAPE).
Detailed description
Conventional Oxygen Therapy (COT) is the established first-line treatment for High-Altitude Pulmonary Edema (HAPE). Despite the proven efficacy of High-flow Nasal Cannula (HFNC) in treating other forms of acute respiratory failure and pulmonary edema, its clinical role in the context of HAPE remains poorly defined. To address this gap, the investigators conducted a study comparing the efficacy of HFNC versus COT in providing respiratory support and accelerating clinical recovery for patients with HAPE.
Interventions
DEVICEHigh-flow Nasal Cannula Oxygen Therapy (HFNC)
High-flow Nasal Cannula (HFNC) therapy was administered using a dedicated system with integrated active humidification and a heated-wire circuit, delivered via a wide-bore nasal cannula.
Sponsors
Third Military Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of treatment failure | From date of randomization until the time of first documented treatment failure from any cause, assessed up to about 7 days. | Treatment failure: defined as the inability to achieve or maintain the target SpO2 despite optimized oxygen therapy, patient intolerance to the assigned oxygen therapy, or the need for treatment escalation (e.g., non-invasive ventilation or endotracheal intubation) and emergency descent to prevent further clinical deterioration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to weaning off supplemental oxygen | From date of randomization to oxygen therapy completion (oxygen weaning), an average of 3-5 days. | Hours from randomization to successful weaning to room air. |
| The Net change in Lung CT Severity Score | Day 3 | Change in Lung CT Severity Score from baseline to Day 3 post-randomization |
| Evolvement of SpO2 | From enrollment to treatment completion, an average of 3-5 days. | SpO₂ is the percentage of oxygen-saturated hemoglobin in the blood, indicating how well oxygen is being delivered throughout the body. It was measured non-invasively using a pulse oximeter, a small device placed on a participant's fingertip, which uses light to estimate blood oxygen levels. |
| Incidence of oxygen therapy-related complications | From randomization to discharge, assessed up to about 7 days. | Incidence of oxygen therapy-related complications during hospital stay. |
Countries
China
Contacts
CONTACTYiding Li, Dr.
PRINCIPAL_INVESTIGATORYe Fan, Dr.
Department of Respiratory Disease, Xinqiao Hospital, Third Military Medical University, 83 Xinqiao Zhengjie, Shapingba District, ChongQing 400000, China
Outcome results
None listed