A Clinical trial to Verify the Efficacy and Safety of Electric Phlegm Suction system: Prospective, Multi-center, Randomized, Open-label, Pivotal study

MCEA0 个研究点目标入组 148 人开始时间: 待定最近更新: 2022年5月2日

适应症

试验速览

暂无简介。

•Those aged =19 among the in-patients in the intensive care unit of the study site.
•- Patients who have been applied with mechanical ventilation through the artificial airway such as tracheal intubation or tracheotomy and have maintained PaO2/FiO2 values above 100mmHg.
•- Patients whose application time of mechanical ventilation does not exceed 36 hours
•- Those who are expected to see continued application of mechanical ventilation for at least 72 hours after participating in this study

•- The subject or a legally acceptable representative refuses to participate in the study
•- Those who have become pregnant or are planning to become pregnant during the study period
•- Patients who need to maintain their plateau pressure with the mechanical ventilation setting of FiO2 exceeding 80% or exceeding Pplat of 30cmH2O.
•- Patients with severely lowered immune function such as advanced hematologic malignancy, bone marrow transplantation failure, agranulocytosis, and absolute neutrophil count (ANC) of <500/mm3
•- Those with unstable cardiovascular conditions such as arrhythmia accompanied by hemodynamic instability and severe hypoxemia
•- Those who continue to bleed due to hemorrhagic causes, including multiple traumas or thrombocytopenia
•- If the patient is scheduled for or had performed a solid organ transportation on the day of study participation, or self-recovered through cardiopulmonary resuscitation (CPR)
•- Patients with pulmonary disease accompanied by hemoptysis
•- In addition, if the medical staff decides that it is not appropriate to apply the investigational device to the subject or perform bronchoscopy

发起方

MCEA