A Clinical trial to Verify the Efficacy and Safety of Electric Phlegm Suction system
- Conditions
- Diseases of the respiratory system
- Registration Number
- KCT0007115
- Lead Sponsor
- MCEA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 148
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparative assessment on the damage of the airway mucosa between the test group and the control group
- Secondary Outcome Measures
Name Time Method Comparison of the difference in the degree of damage to the airway mucosa between the test group and the control group ;Difference in the incidence of ventilator-associated pneumonia between the test group and the control group ;The incidence of malfunction of the investigational device that has been applied to the test group