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临床试验/NCT07451405
NCT07451405
招募中
不适用

The Efficacy of Oscillation and Lung Expansion (OLE) Therapy Evaluated by Compterized Tomography (CT) and Electrical Impedance Tomography(EIT)in Prolonged Mechanical Ventilated Patients With Atelectasis: A Multicenter Randomized Contralled Trial

Capital Medical University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年3月15日最近更新:

概览

阶段
不适用
状态
招募中
发起方
Capital Medical University
入组人数
60
试验地点
2
主要终点
Change in Atelectatic Lung Area on Chest CT

概览

简要总结

High frequency chest wall oscillation (HFCWO) is currently one of the most common and widespread mechanical airway clearance techniques (ACTs) in clinical practice in China. As an external airway oscillation technique, it has been proven in previous clinical practices that it can help clear secretions by vibrating the chest wall, loosening the secretions adhering to the airway walls and promoting ciliary movement, thereby improving lung ventilation and re-expansion. However, there are still some groups of patients for whom this technique is not suitable in clinical practice, such as those who are uncomfortable with the oscillation, have damaged skin on the chest and back, have unstable rib fractures, or have poorly positioned tracheostomy tubes. In recent years, integrating multiple techniques into a single treatment has become a trend. Among them, oscillation and lung expansion (OLE) combines continuous positive airway pressure (CPAP), continuous high-frequency oscillation (CHFO), and nebulization, which can effectively clear airway secretions and promote lung re-expansion. Currently, only a few studies have confirmed that OLE has a positive impact on improving respiratory function in patients with acute respiratory failure, severe burns, and after lung surgery.

This study aims to further compare the effects of the above two mechanical ACTs on improving lung ventilation and re-expansion by electrical impedance tomography (EIT), and optimize the clinical practice of physical therapists.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, 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

  • Age ≥18 years old
  • The following characteristics of high mucus secretion in the airway occur along with pulmonary infection: coughing up a large amount of white sticky phlegm, yellow phlegm or yellow purulent phlegm; Phlegm sounds can be heard in the lungs. The frequency of sputum aspiration is higher than once every 4 hours
  • Tracheotomy time ≥7 days
  • Vital signs are stable.

排除标准

  • Hemodynamic instability
  • Inhaled oxygen concentration (FiO2) \> 60%
  • Untreated pneumothorax
  • Patients who have undergone total pneumonectomy
  • Hemoptysis
  • Pulmonary bullae, etc.
  • Patients with delirium and restlessness

研究组 & 干预措施

Coventional therapy group

Placebo Comparator

This group conducted casual treatment and airway clearance (except oscillation an lung expansion therapy)

干预措施: High frequency chest wall oscillation or other airway clearance therapy (Other)

OLE group

Experimental

This group conducted casual treatment and oscillation an lung expansion on daily therapy

干预措施: High frequency chest wall oscillation or other airway clearance therapy (Other)

OLE group

Experimental

This group conducted casual treatment and oscillation an lung expansion on daily therapy

干预措施: Oscillation and lung expansion (Other)

结局指标

主要结局

Change in Atelectatic Lung Area on Chest CT

时间窗: Baseline and 10 days post-treatment

Atelectatic lung area will be quantified on chest computed tomography (CT) images by a blinded radiologist using imaging analysis software. The primary outcome is the change in atelectatic lung area from baseline to 10 days post-treatment. The unit of the measures is Square centimeters (cm²)

次要结局

  • Ventilation distribution on Electrical impedance tomography (EIT) evaluation(at admission and 3days/7days/10 days after treatment)
  • Lung Ultrasound score(LUS)(at admission and 10 days after treatment)
  • Oxygenation index(at admission and 10 days after treatment)
  • the score on Modified Borg dyspnea scale(at admission and 10 days after treatment)
  • The Clinical Pulmonary Infection Score(from enrollment to 2 weeks after the treatment)
  • daily cost(in 10 days after admission)

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

Shuo Chen

Physical therapy

Capital Medical University

研究点 (2)

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