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临床试验/NCT02907840
NCT02907840已完成不适用

Prediction of Response to Recruitment Maneuvers in Patients With Acute Respiratory Failure

Università degli Studi di Ferrara2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2016年4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
14
试验地点
2
主要终点
Significant reduction in silent spaces (i.e. non ventilated lung areas) during incremental PEEP steps

研究概览

简要总结

The study will explore the possibility to predict potential for recruitment in acute hypoxemic respiratory failure patients by electrical impedance tomography (EIT) Swisstom BB2 (Swisstom, Landquart, Switzerland) during stepwise increase in positive end-expiratory pressure (PEEP) followed by recruitment maneuver (RM). It will compare data obtained by EIT to those obtained by pressure-volume (P-V) curves on respiratory system mechanics and data on pulmonary gas exchange.

详细描述

The investigators will monitor lung ventilation by EIT during the whole protocol and perform P-V curves and arterial blood gas analysis at every step of the protocol.

Participants will be sedated and paralyzed, ventilated in volume-controlled with protective ventilation (tidal volume=6-8 mL/Kg of predicted body weight and respiratory rate set to obtain normal pH) then the protocol will follow 5 steps each lasting 20 minutes to obtain clinical stability:

  1. PEEP 5 centimeter of water (cmH2O)
  2. PEEP 10 cmH2O
  3. Recruitment maneuver followed by PEEP 15 cmH2O
  4. PEEP 10 cmH2O
  5. PEEP 5 cmH2O

研究设计

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

  • Patients with acute hypoxemic respiratory failure defined by recent known clinical insult or worsening of respiratory symptoms and arterial pressure of oxygen to inspired fraction of oxygen ratio (PaO2/FiO2) ≤300 mmHg
  • Patient on invasive mechanical ventilation
  • Age ≥18 years
  • Written informed consent

排除标准

  • Pregnancy
  • Unstable hemodynamic condition requiring blood transfusion or adjustment of inotropics more often than every hour
  • FiO2 ≥80% or clinical suspicion of pulmonary embolism
  • Pneumothorax
  • Chronic obstructive pulmonary disease (COPD) with clinical symptoms of lung emphysema as evidenced by chest radiography or computed tomography or autoPEEP > 5 cmH2O
  • Intracranial hypertension
  • Impossibility to correctly position the EIT belt (e.g., dressings, chest drainage, etc.)
  • Contraindications to EIT (e.g., implantable cardiac defibrillator, pacemaker, instable spinal lesions)

结局指标

主要结局

Significant reduction in silent spaces (i.e. non ventilated lung areas) during incremental PEEP steps

时间窗: Within 20 minutes from PEEP increase

次要结局

未报告次要终点

研究者

发起方
Università degli Studi di Ferrara
申办方类型
Other
责任方
Principal Investigator
主要研究者

Savino Spadaro

Researcher

Università degli Studi di Ferrara

研究点 (2)

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