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临床试验/NCT06675942
NCT06675942招募中不适用

Evaluating the Short-term Efficacy of Two Oscillation Techniques in Hypersecretive Mechanically Ventilated Patients: a Randomized Crossover Trial

Capital Medical University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年11月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
24
试验地点
1
主要终点
End-expiratory lung impedance (EELI)

研究概览

简要总结

Although mechanical ventilation (MV) is life-saving, it is associated with several complications. The establishment of an artificial airway impairs the cough reflex and mucociliary function, leading to the accumulation of secretions in the tracheobronchial tree. This increases the risk of pneumonia and lung atelectasis. Usual care for mechanically ventilated patients includes airway suctioning via the tracheostomy tube, which clears only a limited portion of the airway and is ineffective at removing peripheral airway secretions.

To address this, airway clearance guidelines recommend various airway clearance techniques (ACTs) for mechanically ventilated patients to enhance mucus removal. However, the lack of standardized, effective evaluation criteria makes selecting the optimal ACT a challenge.

详细描述

The aim of this randomized cross-over study was to compare the effectiveness of oscillation and lung expansion (OLE) versus high-frequency chest wall oscillation (HFCWO) on lung aeration and ventilation distribution, as assessed by EIT, in medically complex, hypersecretive patients with tracheostomy tubes requiring long-term mechanical ventilation (MV).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • Eligible participants were patients aged ≥18 years with airway hypersecretion, admitted to the ICU,
  • Requiring more than 48 hours of MV.

排除标准

  • Malignant arrhythmia
  • Acute myocardial ischemia
  • Pneumothorax, pulmonary bulla, barotrauma, or other lung diseases,
  • Hemorrhagic disease or coagulation abnormalities with bleeding tendencies
  • Skin trauma on the chest
  • Pulmonary embolism
  • Presence of a permanent or temporary pacemaker
  • Untreated spinal and rib fractures
  • Any condition deemed inappropriate for study inclusion by the researchers.

结局指标

主要结局

End-expiratory lung impedance (EELI)

时间窗: at the end of treatment (T1) and at 1 hour (T2), 2 hours (T3), 4 hours (T4)

次要结局

  • Tidal impedance variation (TV)(at the end of treatment (T1) and at 1 hour (T2), 2 hours (T3), 4 hours (T4))
  • Respiratory rate(at the end of treatment (T1) and at 1 hour (T2), 2 hours (T3), 4 hours (T4))
  • sputum volume(at the end of treatment (T1) and at 1 hour (T2), 2 hours (T3), 4 hours (T4))
  • center of ventilation (COV)(at the end of treatment (T1) and at 1 hour (T2), 2 hours (T3), 4 hours (T4))

研究者

发起方
Capital Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jingyi Ge

Principal Investigator

Capital Medical University

研究点 (1)

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