A study to see the effect of incremental tidal volume on lung dynamics in ARDS
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To identify the effect of incremental tidal volume on driving pressure and lung compliance in Acute Respiratory Distress Syndrome (ARDS) patients.
研究概览
简要总结
This is a prospective, single-center observational study conducted in an ICU setting to evaluate the effect of incremental tidal volume on lung mechanics in patients with Acute Respiratory Distress Syndrome (ARDS) who are on mechanical ventilation. Patients who are require invasive mechanical ventilation for more than 24 hrs. after ARDS diagnosis will be included. The study involves stepwise increases in tidal volume from 6 mL/kg to 10 mL/kg of predicted body weight (PBW), with continuous monitoring of plateau pressure, PEEP, driving pressure, and lung compliance. The procedure will be conducted on Day 1and repeated on Day 2,3,4 of mechanical ventilation. The aim is to understand how changes in tidal volume affect lung dynamics and to identify ventilatory thresholds that may impact patient safety and outcomes. The study follows strict safety protocols, and all interventions will be immediately stopped if clinical deterioration is observed.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 16.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients aged 16 to 85 years old.
- •2.Diagnosis of ARDS Berlin Criteria for ARDS Acute onset of hypoxemia Bilateral pulmonary infiltrates on chest radiograph or CT scan.
- •Non-cardiogenic cause of pulmonary edema (no clinical signs of left atrial hypertension or heart failure).
- •3.Mechanical Ventilation-Patients who require invasive mechanical ventilation for more than 24 hours after ARDS diagnosis.
排除标准
- •1.Pre-existing Chronic Respiratory Conditions: Chronic obstructive pulmonary disease (COPD), emphysema, or interstitial lung disease.
- •Patients already on prone ventilation, pneumothorax, open lung, increase abdominal pressure.
- •2.Pregnancy: Pregnant women or patients with an unknown pregnancy status.
- •Patients who are in extreme hemodynamic instability.
- •Patient required rescue strategy in prone position and ECMO first 24 hours.
结局指标
主要结局
To identify the effect of incremental tidal volume on driving pressure and lung compliance in Acute Respiratory Distress Syndrome (ARDS) patients.
时间窗: day 0 and day 3 of initiating mechanical ventilation
次要结局
- To identify the effect of changes in lung dynamics with incremental tidal volume on clinical outcomes: 28-day mortality, Ventilator-free days, ICU stay duration, hospital stay
- To identify the effect of changes in lung dynamics with incremental tidal volume with Severity: SOFA Score, PaO2/FiO2 ratio(days 0, 2, 4, 6, and 8.)
- To identify the effect of changes in lung dynamics with incremental tidal volume on initiation of Rescue measures of ventilation like prone ventilation and ECMO support requirements.(duration of mechanical ventilation)
研究者
Dr Ruchi Gupta
Holy Family Hospital