A Clinical Trial to Verify the Efficacy and Safety of Electric Phlegm Suction System
Study Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Device: 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.
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| Active Comparator: 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. |
Procedure: 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.
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Outcome Measures
Primary Outcome Measures
- Evaluation of airway mucosal damage change on 72 hours after application through bronchoscopy results [72 hours after application of the investigational device]
Comparative assessment on the damage of the airway mucosa between the test group and the control group through bronchoscopy results
Secondary Outcome Measures
- Evaluation of airway mucosal damage [At each time point before the application, 7 days, and 14 days after the application of the investigational device]
Comparison of the difference in the degree of damage to the airway mucosa between the test group and the control group
- Incidence of mechanical ventilation-related pneumonia [For 2 weeks from the time of investigational device application]
Difference in the incidence of ventilator-associated pneumonia between the test group and the control group group
- Rate of investigational device malfunction [For 2 weeks from the time of application of investigational device]
The incidence of malfunction of the investigational device that has been applied to the test group
Eligibility Criteria
Criteria
Inclusion Criteria:
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Those aged ≥19 among the in-patients in the intensive care unit of the study site.
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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.
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Patients whose application time of mechanical ventilation does not exceed 36 hours
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Those who are expected to see continued application of mechanical ventilation for at least 72 hours after participating in this study
Exclusion Criteria:
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The subject or a legally acceptable representative refuses to participate in the study
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Those who have become pregnant or are planning to become pregnant during the study period
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Patients who need to maintain their plateau pressure with the mechanical ventilation setting of FiO2 exceeding 80% or exceeding Pplat of 30cmH2O.
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Patients with severely lowered immune function such as advanced hematologic malignancy, bone marrow transplantation failure, agranulocytosis, and absolute neutrophil count (ANC) of <500/mm3
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Those with unstable cardiovascular conditions such as arrhythmia accompanied by hemodynamic instability and severe hypoxemia
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Those who continue to bleed due to hemorrhagic causes, including multiple traumas or thrombocytopenia
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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)
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Patients with pulmonary disease accompanied by hemoptysis
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In addition, if the medical staff decides that it is not appropriate to apply the investigational device to the subject or perform bronchoscopy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Korea University Anam Hospital | Seoul | Korea, Republic of | 02841 | |
| 2 | Korea University Guro Hospital | Seoul | Korea, Republic of | 08308 | |
| 3 | Korea University Ansan Hospital | Seoul | Korea, Republic of | 15355 |
Sponsors and Collaborators
- Lmeca
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LMECA.A1000.CIP