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临床试验/NCT04149873
NCT04149873已完成不适用

Effectness of Treatment With Mechanical Insufflation-Exsufflation in Surgical Critically Ill Patients With Impaired Cough Function

Chimei Medical Center2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2015年9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
240
试验地点
2
主要终点
mortality rate

研究概览

简要总结

Patients defined with impaired cough function as maximum expiratory pressure (MEP) < 60cmH2O. Collected the patients in our surgical ICU who are able to reach 6-8CC/IBW under pressure support mode for 24 hours and MEP < 60cmH2O. Then the patients will be allocated to 3 groups to receive (1) conventional CPT (control group) (2) MI-E (study group A) (3) MI-E plus CPT (study group B) until 48 hours after extubation. Reintubation rates, ICU mortality and post-extubation ICU length of stay will be analyzed to evaluate its effects.

详细描述

Endotracheal intubation and mechanical ventilation are always used to treat acute respiratory failure in critically ill patients. Successful weaning from ventilator and extubation are crucial to determine the prognosis when patient's underlying disease getting improvement. The reasons for extubation failure include lack of improvement of on the work of breathing, hypoxemia, respiratory acidosis, conscious disturbance and retained respiratory secretions, etc. In our clinical practice, the factor of retained respiratory secretions plays an important role in successful extubation.

Traditional chest physiotherapy (CPT) is commonly used to help the critically patients in the effective expulsion of airway secretions. In recent years, new advanced techniques mechanical insufflations-exsufflation (MI-E) and high frequency chest wall oscillation (HFCWO)have been developed to get more effective to remove secretions for patients suffered from acute respiratory failure. The above devices have been described as an effective techniques for patients with chronic neuromuscular weakness, cystic fibrosis and bronchiectasis. By the knowledge, only one study mentioned about MI-E could reduce the reintubation rate and shorten the ICU length of stay. But its limitations include less of case number and not focusing on impaired cough function patients.

In this study, patients defined with impaired cough function as maximum expiratory pressure (MEP) < 60cmH2O. Collected the patients in our surgical ICU who are able to reach 6-8CC/IBW under pressure support mode for 24 hours and MEP < 60cmH2O. Then the patients will be allocated to 3 groups to receive (1) conventional CPT (control group) (2) MI-E (study group A) (3) MI-E plus CPT (study group B) until 48 hours after extubation. Reintubation rates, ICU mortality and post-extubation ICU length of stay will be analyzed to evaluate its effects.

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
Single (Participant)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1.Written Informed Consent given by the patient or, if not possible, by a legally authorized representative and/or an independent physician as authorized by the competent ethics committee (EC) or independent review board (IRB) and local regulations.
  • 2.To be at least 20 years of age.
  • 3.To be treated in an ICU at the time of enrollment.
  • 4.Endotracheal tube in place
  • 5.The patient is mechanically ventilated and reach:
  • Ventialtopr: Pressure support mode
  • reach 6-8CC/IBW, ideal body weight for 24 hours
  • MEP, maximum expiratory pressure < 60cmH2O

排除标准

  • 1.The patient or legally authorized representative refuse
  • 2.< 20 years of age.
  • 3.Neither endotracheal tube nor mechanical ventilator use
  • 4.The patient is mechanically ventilated, but:
  • The ventialtopr mode NOT: Pressure support mode
  • No reach 6-8CC/IBW, ideal body weight for 24 hours
  • MEP, maximum expiratory pressure > 60cmH2O
  • 5.Participation as subject in another interventional study within 30 days prior to the first dose of study treatment, or planned participation in such a study during the study or within 30 days of its completion by the patient.

结局指标

主要结局

mortality rate

时间窗: 1 year

One year mortality rate

次要结局

未报告次要终点

研究者

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

Kuo-Chen Cheng

Principal Investigator

Chimei Medical Center

研究点 (2)

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