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临床试验/NCT02503241
NCT02503241Unknown不适用

Open Lung Strategy in Critically Ill Morbid Obese Patients Lung Imaging and Heart-lung Interaction

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
21
试验地点
2
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

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).

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

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

Robert M. Kacmarek

RRT, PhD

Massachusetts General Hospital

研究点 (2)

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