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临床试验/NCT03852394
NCT03852394已完成不适用

Influence of Respiratory Mechanics on Diaphragmatic Dysfunction in COPD Patients Who Have Failed Non-invasive Mechanical Ventilation

University of Modena and Reggio Emilia1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Impact of dynamic intrinsic Positive End Expiratory Pressure on diaphragm function in AECOPD patient who failed NIV

研究概览

简要总结

Although non-invasive mechanical ventilation (NIV) is the gold standard treatment for patients with acute exacerbation of COPD (AECOPD) who develop respiratory acidosis, failure rate are still high ranging from 5% to 40%. Recent studies have shown that the onset of severe diaphragmatic dysfunction (DD) during AECOPD increases risk of NIV failure and mortality in this subset of patients. Although the imbalance between the load and the contractile capacity of inspiratory muscles seems the main cause of AECOPD-induced hypercapnic respiratory failure, data regarding the influence of mechanical derangement on diaphragmatic performance in this acute phase are lacking. With this study we aim at investigating the impact of respiratory mechanics on diaphragm function in AECOPD patients who experienced NIV failure. AECOPD with respiratory acidosis admitted to the ICU of the University Hospital of Modena from 2017-2018 undergoing mechanical ventilation (MV) due to NIV failure were enrolled. The study protocol consisted of two consecutive phases; in the first step measurements of static respiratory mechanics and end expiratory lung volume (EELV) were performed after 30 minutes of MV in volume control mode. In the second step transdiaphragmatic pressure (Pdi) was calculated by means of a sniff maneuver (Maximal Pdi) after 30 minutes of spontaneous breathing trial. Linear regression analysis and Pearson's correlation coefficient was used to asses the association between Maximal Pdi values and static and dynamic mechanical features and the association between Maximal Pdi and Pdi/Maximal Pdi.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • age over 18 years
  • AECOPD with respiratory acidosis admitted to the Respiratory Intensive Care Unit of the University Hospital of Modena (Italy) undergoing endotracheal intubation due to NIV failure.

排除标准

  • history of neuromuscular disease,
  • presence of chest wall deformities,
  • coexistence of interstitial lung disease,
  • presence of pulmonary edema,
  • severe hemodynamic instability,
  • septic shock,
  • evidence of lobar pneumonia or bilateral parenchymal consolidation at chest X-ray on admission,
  • contraindication to NIV,
  • previously assessed diaphragmatic palsy,
  • intracranial hypertension,
  • known pregnancy,
  • need for immediate endotracheal intubation,
  • neurologic impairment,
  • lack of collaboration,
  • unreliable maneuver to calculate maximal transdiaphragmatic pressure.

结局指标

主要结局

Impact of dynamic intrinsic Positive End Expiratory Pressure on diaphragm function in AECOPD patient who failed NIV

时间窗: 30 days from Respiratory Intensive Care Unit admission

Correlation between dynamic intrinsic Positive End Expiratory Pressure and Maximal Pdi in patients undergoing mechanical ventilation for AECOPD

Impact of static elastance on diaphragm function in AECOPD patient who failed NIV

时间窗: 30 days from Respiratory Intensive Care Unit admission

Correlation between static elastance and Maximal Pdi in patients undergoing mechanical ventilation for AECOPD

次要结局

未报告次要终点

研究者

发起方
University of Modena and Reggio Emilia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alessandro Marchioni

Principal Investigator

University of Modena and Reggio Emilia

研究点 (1)

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