A Clinical Trial to Verify the Efficacy and Safety of Electric Phlegm Suction System
NCT ID: NCT05236400
Last Updated: 2022-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
148 participants
INTERVENTIONAL
2022-03-16
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
Subjects who sign the clinical trial consent form and satisfy the inclusion/exclusion criteria are enrolled in this trial, and are randomly assigned to a test group and a control group in a 1:1 ratio.
Airway aspiration is performed through the unmanned electric airway aspiration procedure using the test device (LMECA.A1000), which is the test group, and the manual airway aspiration procedure, which is the control group. Subjects will be evaluated for efficacy and safety on Day 3, Day 7, and Day 14 after application of the clinical trial medical device.
TREATMENT
NONE
Study Groups
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unmanned electric phlegm suction system procedure using an investigational device (LMECA.A1000)
After participating in a clinical trial and receiving unmanned electric airway aspiration, the efficacy and safety are checked on Day 3 and on Day 7 and Day 14 of the follow-up period.
unmanned electric phlegm suction system procedure using an investigational device (LMECA.A1000)
Subjects who have passed the screening test will receive the test device (LMECA.A1000) within a minimum of 3 days and a maximum of 14 days. Efficacy and safety are checked through bronchoscopy before application for clinical trials and 72 hours after application.
Manual phlegm suction system
After participating in a clinical trial and applying manual airway aspiration, the efficacy and safety are checked on Day 3 and on Day 7 and Day 14 of the follow-up period.
Manual phlegm suction system
Subjects who have passed the screening test will receive a manual phlegm suction system procedure using a catheter by professional medical staff within a minimum of 3 days and a maximum of 14 days. Efficacy and safety are checked through a bronchoscopy before application to clinical trials and 72 hours after application.
Interventions
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unmanned electric phlegm suction system procedure using an investigational device (LMECA.A1000)
Subjects who have passed the screening test will receive the test device (LMECA.A1000) within a minimum of 3 days and a maximum of 14 days. Efficacy and safety are checked through bronchoscopy before application for clinical trials and 72 hours after application.
Manual phlegm suction system
Subjects who have passed the screening test will receive a manual phlegm suction system procedure using a catheter by professional medical staff within a minimum of 3 days and a maximum of 14 days. Efficacy and safety are checked through a bronchoscopy before application to clinical trials and 72 hours after application.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
ALL
No
Sponsors
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Lmeca
INDUSTRY
Responsible Party
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Locations
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Korea University Anam Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Korea University Ansan Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LMECA.A1000.CIP
Identifier Type: -
Identifier Source: org_study_id
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