Non-invasive ventilator
OtherTreatment with non-invasive ventilator (CPAP, BiPAP) in the intervention group.
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NCT Number: NCT07600086
High-Altitude Polycythemia Study
This study aims to evaluate the clinical efficacy of non-invasive ventilation (NIV) in treating patients with high-altitude polycythemia (HAPC).
Participants will be enrolled according to the international diagnostic criteria for high-altitude polycythemia. The study will use both retrospective cohort and prospective study methods.
All participants will receive standard basic care. In addition, the intervention group will receive non-invasive ventilation treatment using either BiPAP or CPAP mode.
Key measurements, including routine blood tests, liver function, renal function, uric acid, blood lipid profile, electrocardiogram and echocardiography, will be collected as primary and secondary outcome measures to assess the effects of the treatment.
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Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
People's Hospital of Xizang Autonomous Region；Lhasa, Xizang Autonomous Region, China, 850000, Xizang, China
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Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Diagnosed with high-altitude polycythemia (HAPC).
- Aged 18 years or older, with no gender restriction.
- Voluntarily participate in the study and sign the informed consent form.
Exclusion criteria
- Disturbance of consciousness.
- Inability to independently clear airway secretions, with the risk of aspiration.
- Severe upper gastrointestinal bleeding.
- Hemodynamic instability.
- Upper airway obstruction.
- Un drained pneumothorax or mediastinal emphysema.
- Conditions that prevent mask wearing, such as facial trauma or deformity.
- Patient non-compliance.
Treatment and study plan
Primary outcomes
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Change in Hemoglobin (Hb) Concentration
Time frame: Baseline, 3 months, 6 months after treatment initiation
The primary endpoint is the absolute change in blood hemoglobin concentration (g/dL) from baseline to 3-month and 6-month follow-up. A reduction in hemoglobin level is defined as a clinically significant improvement in high altitude polycythemia status.
Secondary outcomes
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Change in Serum uric acid and blood lipid levels
Time frame: Baseline, 6 months
Changes in serum uric acid, total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) will be measured.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Tibet Autonomous Region People's Hospital
Other
Registry information
Official study title
Clinical Study on the Therapeutic Effect of Non-Invasive Ventilator in the Treatment of High-Altitude Polycythemia
Acronym: NIV-HAPC
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- May 20, 2026
- Registry last updated
- May 20, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.