Open Lung Strategy in Critically Ill Morbid Obese Patients Lung Imaging and Heart-lung Interaction
试验速览
- 阶段
- 不适用
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Respiratory System Elastance
研究概览
简要总结
The goal of this interventional crossover study in morbidly obese intubated and mechanically ventilated patients is to describe the respiratory mechanics and the heart-lung interaction at titrated positive end-expiratory pressure levels following a recruitment maneuver with transthoracic echocardiography and electric impedance tomography imaging.
详细描述
Obese patients under mechanical ventilation are more likely to develop atelectasis as a consequence of the increased abdominal weight. Atelectasis is the primary responsible for respiratory insufficiency and impossibility to wean obese patients from respiratory support.
In a previous study we demonstrated the efficacy of the application of titrated PEEP levels following a recruitment maneuver in obese patients, i.e. improvement in respiratory mechanics and gas exchanges without negative hemodynamic effects.
The application of lung and heat imaging will allow us to quantitatively describe:
- Increase in aerated lung tissue (reduction of atelectasis)
- Reduction of over-inflation of the ventilated regions
- Recoupling of ventilation and perfusion
- Improvement in right heart function by reduction of right heart afterload
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •ICU admitted requiring intubation and mechanical ventilation
- •BMI ≥ 35 kg/m2
- •Waist circumference > 88 cm (for women)
- •Waist circumference > 102 cm (for men)
排除标准
- •Known presence of esophageal varices
- •Recent esophageal trauma or surgery
- •Severe thrombocytopenia (Platelets count ≤ 5,000/mm3)
- •Severe coagulopathy (INR ≥ 4)
- •Presence or history of pneumothorax
- •Pregnancy
- •Patients with poor oxygenation index (PaO2/FiO2< 100 mmHg with at least 10 cmH2O of PEEP)
- •Pacemaker and/or internal cardiac defibrillator
- •Hemodynamic parameters: systolic blood pressure (SBP) <100 mmHg and >180 mmHg, or if SBP is between 100-180 mmHg on high dose of IV continuous infusion norepinephrine (>20 μg per minute), or dobutamine (>10 μg per minute), or dopamine (>10 μg per Kg per minute), or epinephrine (>10 μg per minute).
研究组 & 干预措施
PEEP_Titration_INCREMENTAL
The investigators will compare 3 levels of PEEP (BASELINE versus PEEP INCREMENTAL versus PEEP DECREMENTAL). Baseline PEEP is based in the standard of care PEEP used in the participant units. PEEP incremental value is based in transpulmonary pressure.
Intervention : PEEP INCREMENTAL
干预措施: PEEP INCREMENTAL (Procedure)
PEEP_Titration_INCREMENTAL
The investigators will compare 3 levels of PEEP (BASELINE versus PEEP INCREMENTAL versus PEEP DECREMENTAL). Baseline PEEP is based in the standard of care PEEP used in the participant units. PEEP incremental value is based in transpulmonary pressure.
Intervention : PEEP INCREMENTAL
干预措施: PEEP DECREMENTAL (Procedure)
PEEP_Titration_DECREMENTAL
The investigators will compare 3 levels of PEEP (BASELINE versus PEEP INCREMENTAL versus PEEP DECREMENTAL). Baseline PEEP is based in the standard of care PEEP used in the participant units. PEEP decremental value is based in lung recruitment maneuver followed by a best compliance curve during PEEP decrements.
Intervention :PEEP DECREMENTAL
干预措施: PEEP INCREMENTAL (Procedure)
PEEP_Titration_DECREMENTAL
The investigators will compare 3 levels of PEEP (BASELINE versus PEEP INCREMENTAL versus PEEP DECREMENTAL). Baseline PEEP is based in the standard of care PEEP used in the participant units. PEEP decremental value is based in lung recruitment maneuver followed by a best compliance curve during PEEP decrements.
Intervention :PEEP DECREMENTAL
干预措施: PEEP DECREMENTAL (Procedure)
结局指标
主要结局
Respiratory System Elastance
时间窗: During study time points :baseline, PEEP incremental, PEEP decremental
Difference in Respiratory System Elastance measured in cmH2O/L
次要结局
- Lung mechanics - Compliance(Study time points: baseline, PEEP incremental, PEEP decremental)
- Lung mechanics - Airway resistances(During study time points: baseline, PEEP incremental, PEEP decremental)
- Survival(28 days after the performance of the study protocol)
研究者
Robert M. Kacmarek
RRT, PhD
Massachusetts General Hospital