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临床试验/NCT06689020
NCT06689020尚未招募不适用

Effect of Continuous High-frequency Oscillation (CHFO) and Continuous Positive Expiratory Pressure (CPEP) Therapy on Lung RECRUITment Using Electrical Impedance Tomography (EIT) - The PEP-RECRUIT Study

University of Genova1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2024年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
26
试验地点
1
主要终点
To assess changes in systemic oxygenation

研究概览

简要总结

This single-center observational study aims to assess the effects of continuous high-frequency oscillation (CHFO) and continuous positive expiratory pressure (CPEP) therapy on lung recruitment using electrical impedance tomography (EIT) in spontaneously breathing patients admitted to the intensive care unit.

研究设计

研究类型
Observational
观察模型
Case Crossover
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

  • Patients who require pulmonary expansion and airway clearing as per clinical indication
  • Patients who provide valid informed consent according to local regulations
  • PaO2/FiO2 < 200 mmHg at inclusion
  • Patient on the Airway Care Score (ACS) < 7

排除标准

  • Refuse to participate
  • Age < 18 years
  • Hemodynamic instability, defined as systolic arterial pressure < 90 mmHg or mean pressure < 60 mmHg
  • Contraindication to using an EIT (i.e., pacemaker or defibrillator)
  • Inability to properly position the EIT device for anatomical reasons

结局指标

主要结局

To assess changes in systemic oxygenation

时间窗: Immediately before starting treatment (PEP or CHFO), immediately after the end of treatment, at 30 minutes after the end of treatment and at 60 minutes after the end of treatment

Arterial partial pressure of oxygen (PaO2, mmHg) and PaO2/FiO2 ratio (mmHg)

Changes in lung recruitment using EIT

时间窗: Immediately before starting treatment (PEP or CHFO), immediately after the end of treatment, at 30 minutes after the end of treatment and at 60 minutes after the end of treatment

Absolute reduction in the percentage (%) of lung volume collapse assessed with the electrical impedance tomography (EIT)

次要结局

  • Mean arterial pressure, mmHg(Immediately before starting treatment (PEP or CHFO), immediately after the end of treatment, at 30 minutes after the end of treatment and at 60 minutes after the end of treatment)
  • Heart rate min-1(Immediately before starting treatment (PEP or CHFO), immediately after the end of treatment, at 30 minutes after the end of treatment and at 60 minutes after the end of treatment)

研究者

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

Lorenzo Ball

Prof.

University of Genova

研究点 (1)

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