None listed
Conditions
Interventions
Medical Device : Experimental group: Discharge of sputum using Auto Suction system.
Control group: Discharge of sputum using regular closed suction system.
Sponsors
Seoul National University Bundang Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Selection criteria 1. Adults over 19 years of age 2. Critical patients who are diagnosed with pneumonia and need mechanical ventilation 3. A person who voluntarily decided to participate in this clinical trial and agreed to the subject's explanation and consent in writing 4. A person who is willing to comply with the clinical trial plan
Exclusion criteria
Exclusion criteria: 1. A person who does not receive a bronchoscopy 2. If you are not expected to maintain mechanical ventilation for at least 3 days because you are in critical condition with an APACHE II score of 30 or higher, which is expected to be evaluated after 24 hours of initial admission for simple monitoring; 3. If the ventilator setting is FiO2>80% (intake oxygen concentration) or Plat(pressure when resting before exhalation)>30cmH2O is required to maintain high flat airway pressure 4. In the case of progressive blood cancer, failure to transplant bone marrow, granulocytosis, and severe immunodeficiency conditions such as ANC<400/mm3 5. If you have blood transfusions 6. Pregnant women or persons planning to conceive during the clinical trial period; 7. A person who has received CPR within five days of the screening date 8. Other cases where the medical staff finds it difficult to apply the medical device in consideration of the patient's condition; 9. A person who is currently participating in another clinical trial or has participated in another clinical trial within 90 days as of the screening date 10. Other cases where the tester determines that it is difficult to apply the medical device considering the patient's condition or that participation in the clinical trial is inappropriate because it may affect the results of the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference of CPIS, number of discharge of sputum, sputum CC, satisfaction of the device evaluated by medical faculty | — |
Secondary
| Measure | Time frame |
|---|---|
| Abnormal cases, incidence of complications, damage to airway mucous membranes, occurrence rate of malfunction of test equipment (assessed only by test group) | — |
Countries
Korea, Republic of
Contacts
Public ContactHYO CHAN PARK
Seoul National University Bundang Hospital
Outcome results
None listed