High-Altitude Polycythemia Study (NIV-HAPC)
Clinical Study on the Therapeutic Effect of Non-Invasive Ventilator in the Treatment of High-Altitude Polycythemia
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.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Gesang Luobu, MD
- 电话号码：8618108912487
- 邮箱：kelsangnorbu@hotmail.com
学习地点
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Xizang、中国
- People's Hospital of Xizang Autonomous Region；Lhasa, Xizang Autonomous Region, China, 850000
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Xizang、中国
- Xizang Autonomous Region People's Hospital
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接触：
- Yang li hui
- 电话号码：13638992795
- 邮箱：1640794768@qq.com
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
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Treatment with non-invasive ventilator (CPAP, BiPAP) in the intervention group.
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无干预：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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Hemoglobin (Hb) Concentration
大体时间：Baseline, 3 months, 6 months after treatment initiation
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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.
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Baseline, 3 months, 6 months after treatment initiation
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Serum uric acid and blood lipid levels
大体时间：Baseline, 6 months
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Changes in serum uric acid, total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) will be measured.
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Baseline, 6 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- ME-TBHP-25-014
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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