跳至主要内容
临床试验/NCT02105220
NCT02105220已完成不适用

Chest Wall Influence on Respiratory System Mechanics in Morbidly Obese Patients

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2013年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
1
主要终点
End Expiratory Lung Volumes

研究概览

简要总结

The goal of this study is to describe the influence of the chest wall on the respiratory system mechanics in morbidly obese patients and in patients with high intra-abdominal pressure.

The effects of increasing and decreasing positive end-expiratory pressure (PEEP) on chest wall and total respiratory system mechanics, lung volumes and gas exchange will be evaluated, both during controlled and assisted mechanical ventilation.

Patients will be studied, first, during the acute phase of respiratory failure, when requiring intubation and controlled mechanical ventilation. Then, patients will be evaluated again during weaning from the ventilator to assess the influence of PEEP in assisted ventilation prior to extubation.

详细描述

The goal of this study is to describe the influence of the chest wall on the respiratory system mechanics. Investigators want to describe how extreme obesity and Intra-Abdominal Hypertension (IAH) affect normal respiratory system behavior. The effects of increasing and decreasing positive end-expiratory pressure (PEEP) on respiratory system mechanics, lung volumes and gas exchange will be evaluated, both during controlled and assisted mechanical ventilation.

Investigators will record and compare lung volumes, airway and transpulmonary pressure, gas exchange and hemodynamic changes caused by variations of PEEP. Patients will be studied, first, during the acute phase of respiratory failure, when requiring intubation and controlled mechanical ventilation. Patients will then again be evaluated during weaning from the ventilator to assess the influence of PEEP in assisted ventilation prior to extubation.

Investigators believe that assessment of the transpulmonary pressure and lung volumes is essential to correctly evaluate respiratory system function in patients in which the relationship between the lung and chest wall is altered. Improper mechanical ventilation leads to lung damage. High ventilatory volume/pressure are associated with lung overdistension, while low volume/pressure leads to lung collapse and cyclic opening and closing of alveoli. All of these mechanisms have been associated with ventilator induced lung injury and poorer outcomes. Adequate PEEP and transpulmonary pressure are fundamental in preventing this vicious cycle.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years or older
  • Requiring intubation and mechanical ventilation
  • BMI≥40 kg/m2 or IAP≥12 mmHg

排除标准

  • Known presence esophageal varices
  • Recent esophageal trauma or surgery
  • Severe thrombocytopenia (PTL≤10,000/mm3)
  • Severe coagulopathy (INR≥2)
  • Presence of pneumothorax
  • Pregnancy
  • Patients with diagnosed moderate to severe ARDS or with poor oxygenation index (PaO2/FiO2 < 200 mmHg)

结局指标

主要结局

End Expiratory Lung Volumes

时间窗: 2 hours

EELV variation at different levels of PEEP in mechanically ventilated and sedated morbidly obese patients and patients with intraabdominal hypertension

次要结局

  • Gas exchange(20 minutes)
  • Gas Exchange(24 hours)
  • Work of breathing(20 minutes)
  • End Expiratory Lung Volume(24 hours)
  • Respiratory mechanics(20 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert M. Kacmarek

PhD RRT

Massachusetts General Hospital

研究点 (1)

Loading locations...

相似试验