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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 number of times according to the needs of the patient. Therefore, an electric phlegm suction system that can compensate for the shortcomings has been developed. The purpose of this clinical trial is to compare and evaluate the efficacy and safety of the test device by applying the unmanned electric phlegm suction system procedure using an investigational device (LMECA.A1000) and the conventional manual airway aspiration procedure to the patients who received mechanical ventilation through the artificial airway in this clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| unmanned electric phlegm suction system procedure using an investigational device (LMECA.A1000) | Experimental | 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. |
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| Manual phlegm suction system | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| unmanned electric phlegm suction system procedure using an investigational device (LMECA.A1000) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of airway mucosal damage change on 72 hours after application through bronchoscopy results | Comparative assessment on the damage of the airway mucosa between the test group and the control group through bronchoscopy results | 72 hours after application of the investigational device |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of airway mucosal damage | Comparison of the difference in the degree of damage to the airway mucosa between the test group and the control group | At each time point before the application, 7 days, and 14 days after the application of the investigational device |
| Incidence of mechanical ventilation-related pneumonia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jae Myung Lee | Contact | 070-7700-4493 | ljm3225@hanmail.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Anam Hospital | Recruiting | Seoul | 02841 | South Korea |
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This clinical trial is a multicenter, randomized, parallel design, open-label, confirmatory clinical trial.
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.
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| Manual phlegm suction system | Procedure | 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. |
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Difference in the incidence of ventilator-associated pneumonia between the test group and the control group group |
| For 2 weeks from the time of investigational device application |
| Rate of investigational device malfunction | The incidence of malfunction of the investigational device that has been applied to the test group | For 2 weeks from the time of application of investigational device |
| Korea University Guro Hospital | Recruiting | Seoul | 08308 | South Korea |
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| Korea University Ansan Hospital | Recruiting | Seoul | 15355 | South Korea |
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