None listed
Conditions
Interventions
Medical Device, Procedure/Surgery : This clinical trial is a multicenter, randomized, parallel design, open-label, confirmatory clinical trial. Subjects who sign the clinical trial consent form and s
Sponsors
LMCEA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparative assessment on the damage of the airway mucosa between the test group and the control group | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Korea, Republic of
Contacts
Public ContactJae Myung Lee
LMCEA
Outcome results
None listed