Utility of extended sessions of prone ventilation among prone ventilated ARDS (Acute Respiratory Distress Syndrome) patients in the reduction of pulmonary and renal inflammatory biomarkers and mortality outcomes – A Prospective observational study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- A reduction of at least 25% in the pulmonary and renal inflammatory biomarkers
研究概览
简要总结
This is a prospective, observational, single-centre study conducted to evaluate the utility of extended prone ventilation sessions among patients with Acute Respiratory Distress Syndrome (ARDS). The study will include 45 adult ICU patients receiving prone ventilation as part of routine clinical management. The primary outcome is the reduction in pulmonary and renal inflammatory biomarker levels. Patients receiving standard care with prone ventilation will be observed at three time points: prior to initiation of prone positioning, after 16 hours of prone ventilation, and after 24 hours of prone ventilation. Biomarker levels will be compared across these intervals to assess the effect of extended prone positioning. The secondary outcome is all-cause in-hospital mortality, which will be analyzed to determine any association with duration of prone ventilation.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •(i) Adult patients of moderate-severe ARDS as per the New Global Definition of ARDS (ii) Patients aged 18 years or above who are advised for prone position ventilation (iii) ARDS patients with PaO2/FiO2 less than 150 with PEEP greater than 5 cmH2O with FiO2 of at least 0.6 and on invasive mechanical ventilation.
排除标准
- •(i) Patients with a history of solid organ or bone marrow transplantation, who have been treated with chemotherapy for any type of malignancy, any biological agent, prednisone equivalent of more than 10 mg/day and 700 mg cumulative dose, antiproliferative agents and B-/T-cell depletion medications.
- •(ii) Pregnant patients (iii) Patient with the history of Cardiac arrest (iv) Patients referred for palliative care or discharged against medical advice.
- •(v) Patients diagnosed with chronic kidney disease (CKD) (vi) Patients with penetrating chest injuries, pneumothorax at the time of recruitment.
- •(vii) Patients in the study arm who had to be turned to supine position before 24 hours of continuous prone position ventilation.
- •(viii) Patients who expire within 24 hours of prone position ventilation initiation.
结局指标
主要结局
A reduction of at least 25% in the pulmonary and renal inflammatory biomarkers
时间窗: After 16-20 hours of Prone position ventilation
次要结局
- Renal replacement therapy requirement(28 days of ICU stay)
- Mortality(28 days of ICU stay)
研究者
Ms Shruthi
Kasturba Medical College, Manipal