Evaluation of Effects of Positive End-expiratory Pressure (PEEP) on Lung and Heart Functions in Spontaneous Breathing Obese Subjects.
试验速览
- 阶段
- 不适用
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- End Expiratory Lung Volume
研究概览
简要总结
Aim of this study is to better understand pathophysiology of the alteration of respiratory mechanics and cardiovascular function in obese volunteer subjects. The investigators plan to test this hypothesis with a physiological, interventional study conducted on volunteers by using Electrical Impedance Tomography in a group of patients and magnetic resonance imaging (MRI) in another group.
详细描述
Obese subjects are prone to develop respiratory insufficiency when requiring mechanical ventilation. Atelectasis is the primary responsible for respiratory insufficiency and impossibility to wean obese patients from respiratory support. The investigators do believe that the respiratory system derangements observed in the previous study during the critical illness are already present, although in lower severity, in the obese patients in their basal condition.
This study will help to understand the standard cardiac and respiratory function of an obese non critically ill subject to better target the therapies during the management of the critical illness to reestablish the homeostasis of the system:
The investigator's hypotheses are:
- To demonstrate if morbidly obese patients show atelectasis at spontaneous breathing in the supine position and whether the increase in lung volume following PEEP titration is due to alveolar recruitment rather than overdistention.
- To measure regional variations in ventilation/perfusion coupling at different ventilator settings
- To investigate the role of diaphragm position in the development/treatment of respiratory insufficiency due to increased pleural pressure
- To test if reopening of lung atelectasis through the application o a recruitment maneuver and titrated PEEP level would lead to an improvement in right heart function.
- To assess pulmonary circulation at different levels of PEEP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have a photo identification document
- •BMI ≥ 35 kg/m2
- •Waist circumference > 88 cm (for women)
- •Waist circumference > 102 cm (for men)
排除标准
- •Psychiatric disturbances such as anxiety, depression, schizophrenia requiring pharmacological treatment or hospitalization in the last year
- •Subjects with any known condition, including claustrophobia or pain, which limits their ability to lie in the MR scanner for the duration of the research study
- •Known presence of esophageal varices
- •Recent esophageal trauma or surgery
- •Known Coagulopathy
- •History of pneumothorax
- •Pregnancy
- •Presence of prosthesis incompatible with MR
- •Thoracic diameter grater than 70 cm
- •Resting heart rate (HR) < 50 or > 120 bpm and/or systolic blood pressure < 90 or > 160 mmHg and/or peripheral oxygen saturation (SpO2) < 88%
- •Currently enrolled in another research study
结局指标
主要结局
End Expiratory Lung Volume
时间窗: Change from baseline [0 PEEP] to titrated PEEP level (30 minutes after baseline)
Difference in end expiratory lung volume measured in mL
次要结局
- Heart ejection fraction(Changes from baseline [0 PEEP] at titrated PEEP level (30 minutes after baseline))
- Work of breathing(Change from baseline [0 PEEP] to titrated PEEP level (30 minutes after baseline))
- Right heart volumes(Change from baseline [0 PEEP] at titrated PEEP level (30 minutes after baseline))
研究者
Robert M. Kacmarek
RRT, PhD
Massachusetts General Hospital