Clinical Study on the Therapeutic Effect of Non-Invasive Ventilator in the Treatment of High-Altitude Polycythemia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change in Hemoglobin (Hb) Concentration
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Intervention Group (NIV Treatment)
Patients receive standard basic care plus long-term non-invasive ventilation (NIV) therapy with CPAP or BiPAP mode. Treatment is administered daily, and efficacy is evaluated 3 to 6 months after the intervention.
干预措施: Non-invasive ventilator (Other)
Control Group (Standard Care Only)
Patients receive only standard basic care without non-invasive ventilation therapy. Efficacy is evaluated at the same time points (3 and 6 months) as the intervention group for comparison.
结局指标
主要结局
Change in Hemoglobin (Hb) Concentration
时间窗: 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.
次要结局
- Change in Serum uric acid and blood lipid levels(Baseline, 6 months)
研究者
Gesang Lobb
Chief Physician, Department of Respiratory Medicine
Tibet Autonomous Region People's Hospital