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临床试验/NCT04435613
NCT04435613已完成不适用

Clinical and Physiological Assessment of a Nearly Ultra-protective Lung Ventilation Strategy: A Quasi-experimental Preliminary Study in ARDS Patients

Clinica las Condes, Chile2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年9月4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
10
试验地点
2
主要终点
To analyse the effects of different protective mechanical ventilator strategies on Bohr's dead space (VDBohr/VT) in patients with acute respiratory distress syndrome

研究概览

简要总结

This study aims to determine whether a protective mechanical ventilator strategy generates a reduction in the Bohr´s dead space in patients with moderate or severe acute respiratory distress syndrome (ARDS). Commonly used ventilatory strategies in the clinical practice were applied sequentially to assess their impact. Data obtained from volumetric capnography will be recorded after each ventilatory strategy is applied

详细描述

Protective mechanical ventilation strategies are currently the cornerstone of treatment for patients undergoing mechanical ventilatory support. Among them, we can mention the reduction in tidal volume, the reduction in driving pressure, the PEEP setting, and the respiratory rate reduction. All of these strategies are aimed at preventing ventilator-induced lung injury. Few clinical studies have evaluated the effects of protective mechanical ventilation strategies on dead-space. This study was designed to evaluate dead space and alveolar ventilation with a sequence of protective ventilatory strategies, keeping PEEP levels constant. The ventilatory strategy was developed to reduce tidal volume, set an end-inspiratory pause, and reduce the frequencies of lung tissue impact.

Baseline:

All the patients kept the variables under study constant for 60 minutes. Each of the participants was studied for a period of 150 minutes. PEEP programming was set with transpulmonary end-expiratory pressures to maintain between 0 and 5 cmH2O and was remained constant throughout the study.

Protocol design:

Baseline: Vt 7 ml/kg/PBW Phase I: Vt 6 ml/kg/PBW. Phase II: Vt 5 ml/kg/PBW. Phase III: end-inspiratory pause prolongation until achieving I:E ratio equal to 1, maintaining a constant Vt level (5 ml/kg/PBW) Phase IV: Respiratory rate reduction by 20% of basal conditions, maintaining constant VT level (5 ml/kg/PBW).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

  • Age older than 18 years
  • The requirement of invasive mechanical ventilation for more than 4 hours and less than 72 hours
  • Severe hypoxemia (PAFI < 200) secondary to ARDS

排除标准

  • Heart failure stage IV
  • Chronic obstructive pulmonary disease (COPD) on home oxygen
  • Bronchopulmonary fistula
  • Hypovolemic Shock with active hemorrhage
  • Gastrointestinal bleeding
  • Oesophageal Varices
  • Nasopharynx surgery, recent oesophageal or gastric surgery
  • Massive Pulmonary Thromboembolism
  • Catastrophic respiratory failure requiring urgent extracorporeal life support
  • Respiratory acidosis. Hydrogen potential (pH) is less than 7.20 and PaCO2 higher than 60 mmHg at baseline.

结局指标

主要结局

To analyse the effects of different protective mechanical ventilator strategies on Bohr's dead space (VDBohr/VT) in patients with acute respiratory distress syndrome

时间窗: 150 minutes

After the systematic reduction of the tidal volume, end-inspiratory pause prolongation, and the reduction of the respiratory rate, the optimisation of the dead space and the alveolar ventilation could be generated.

次要结局

未报告次要终点

研究者

发起方
Clinica las Condes, Chile
申办方类型
Other
责任方
Principal Investigator
主要研究者

Martin Benites

Principal Investigator: Martín Hernán Benites Albanese

Clinica las Condes, Chile

研究点 (2)

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