Application of Electrical Impedance Tomography in Evaluating Pulmonary Function Improvement After High Lateral Recumbent Position Therapy in ARDS Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 主要终点
- death
研究概览
简要总结
This randomized controlled trial investigates the effects of prone positioning versus lateral positioning at different angles (30°, 90°, 120°) on pulmonary function improvement in patients with acute respiratory distress syndrome (ARDS). Utilizing electrical impedance tomography (EIT) technology, the study monitors key parameters including ventilation distribution and ventilation-perfusion matching in real time, while integrating respiratory mechanics and blood gas analysis data to comprehensively evaluate the therapeutic efficacy of positional adjustments. The study hypothesizes that high-angle lateral positioning may reduce adverse complications associated with prone positioning while effectively improving oxygenation and pulmonary function. The ultimate objective is to provide a safer and more personalized positional therapy regimen for clinical practice, optimizing ARDS treatment strategies to reduce mortality and enhance patient survival outcomes.
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
- Single (Outcomes Assessor)
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
- •Age >= 18 years.
- •Diagnosis of ARDS according to the Berlin Definition (2023 update).
- •Clinically evaluated as suitable for positional therapy by physicians.
- •Signed informed consent obtained from the patient or legal representative.
- •Absence of severe spinal deformities or musculoskeletal disorders that may compromise safe high lateral positioning.
- •No severe skin conditions (e.g., extensive open wounds or pressure ulcers) that may affect the feasibility of lateral positioning.
排除标准
- •Pregnant or lactating women.
- •Severe cardiac diseases (e.g., unstable arrhythmia or heart failure) that may worsen with positional changes.
- •Severe coagulation disorders with increased bleeding risk.
- •Known allergy to the EIT device or any of its components.
- •Severe psychiatric disorders impairing study compliance.
- •Current participation in experimental therapies that may affect pulmonary function.
- •Severe active infections requiring special isolation measures.
- •Anticipated need for emergency surgery or life-threatening complications within 24 hours.
研究组 & 干预措施
90-degree high lateral position group
Place the patient in the 90-degree high lateral position.
干预措施: Place the patient in the 90-degree high lateral position. (Procedure)
30-degree low lateral position group
Place the patient in the 30-degree low lateral position.
干预措施: Place the patient in the 30-degree low lateral position. (Procedure)
120-degree high lateral position group
Place the patient in the 120-degree high lateral position.
干预措施: Place the patient in the 120-degree high lateral position. (Procedure)
Prone position group
Patients will be placed in the prone position, i.e., lying face down.
干预措施: Patients will be placed in the prone position, i.e., lying face down. (Procedure)
结局指标
主要结局
death
时间窗: One month after treatment
次要结局
- A/P Ratio(24 hours before treatment, 24 hours after treatment)
- Ventilation-Perfusion Ratio(24 hours before treatment, 24 hours after treatment)
- Oxygenation index(24 hours before treatment, 24 hours after treatment)
- Global Inhomogeneity Index, GI(24 hours before treatment, 24 hours after treatment)