High-Altitude Polycythemia Study

N/ANot Yet RecruitingNCT07600086

Tibet Autonomous Region People's Hospital70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

High-altitude Polycythemia HAPC

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Diagnosed with high-altitude polycythemia (HAPC). 2. Aged 18 years or older, with no gender restriction. 3. Voluntarily participate in the study and sign the informed consent form. Exclusion Criteria: 1. Disturbance of consciousness. 2. Inability to independently clear airway secretions, with the risk of aspiration. 3. Severe upper gastrointestinal bleeding. 4. Hemodynamic instability. 5. Upper airway obstruction. 6. Un drained pneumothorax or mediastinal emphysema. 7. Conditions that prevent mask wearing, such as facial trauma or deformity. 8. Patient non-compliance.

Locations (2)

People's Hospital of Xizang Autonomous Region；Lhasa, Xizang Autonomous Region, China, 850000

Xizang, China

Xizang Autonomous Region People's Hospital

Xizang, China

Outcomes

Primary Outcomes

Change in Hemoglobin (Hb) Concentration

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.

Time frame: Baseline, 3 months, 6 months after treatment initiation

Secondary Outcomes

Change in Serum uric acid and blood lipid levels

Changes in serum uric acid, total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) will be measured.

Time frame: Baseline, 6 months