Status:
UNKNOWN
A Clinical Trial to Verify the Efficacy and Safety of Electric Phlegm Suction System
Lead Sponsor:
Lmeca
Conditions:
Other Specified Respiratory Disorders
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
Manual airway aspiration is a task performed by a nurse or caregiver and if the nursing/care work is overloaded, it has the disadvantage that airway aspiration cannot be performed an appropriate numbe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT05236400
Start Date
March 16 2022
End Date
December 31 2023
Last Update
April 5 2022
Active Locations (3)
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1
Korea University Anam Hospital
Seoul, South Korea, 02841
2
Korea University Guro Hospital
Seoul, South Korea, 08308
3
Korea University Ansan Hospital
Seoul, South Korea, 15355