Back to resultsA Clinical Trial to Verify the Efficacy and Safety of Electric Phlegm Suction System
Primary Purpose
Other Specified Respiratory Disorders
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
unmanned electric phlegm suction system procedure using an investigational device (LMECA.A1000)
Manual phlegm suction system
Sponsored by
About this trial
This is an interventional treatment trial for Other Specified Respiratory Disorders
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Korea University Anam HospitalRecruiting
- Korea University Guro HospitalRecruiting
- Korea University Ansan HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
unmanned electric phlegm suction system procedure using an investigational device (LMECA.A1000)
Manual phlegm suction system
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Incidence of mechanical ventilation-related pneumonia
Difference in the incidence of ventilator-associated pneumonia between the test group and the control group group
Rate of investigational device malfunction
The incidence of malfunction of the investigational device that has been applied to the test group
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05236400
Brief Title
A Clinical Trial to Verify the Efficacy and Safety of Electric Phlegm Suction System
Official Title
A Clinical Trial to Verify the Efficacy and Safety of Electric Phlegm Suction System: Prospective, Multi-center, Randomized, Open-label, Pivotal Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lmeca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Other Specified Respiratory Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
unmanned electric phlegm suction system procedure using an investigational device (LMECA.A1000)
Arm Type
Experimental
Arm Description
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.
Arm Title
Manual phlegm suction system
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
unmanned electric phlegm suction system procedure using an investigational device (LMECA.A1000)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Manual phlegm suction system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation of airway mucosal damage change on 72 hours after application through bronchoscopy results
Description
Comparative assessment on the damage of the airway mucosa between the test group and the control group through bronchoscopy results
Time Frame
72 hours after application of the investigational device
Secondary Outcome Measure Information:
Title
Evaluation of airway mucosal damage
Description
Comparison of the difference in the degree of damage to the airway mucosa between the test group and the control group
Time Frame
At each time point before the application, 7 days, and 14 days after the application of the investigational device
Title
Incidence of mechanical ventilation-related pneumonia
Description
Difference in the incidence of ventilator-associated pneumonia between the test group and the control group group
Time Frame
For 2 weeks from the time of investigational device application
Title
Rate of investigational device malfunction
Description
The incidence of malfunction of the investigational device that has been applied to the test group
Time Frame
For 2 weeks from the time of application of investigational device
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jae Myung Lee
Phone
070-7700-4493
Email
ljm3225@hanmail.net
Facility Information:
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae Myung Lee
Email
ljm3225@hanmail.net
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nak-Jun Choi
Email
eks7957@naver.com
Facility Name
Korea University Ansan Hospital
City
Seoul
ZIP/Postal Code
15355
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Je Hyeong Kim
Email
chepraxis@korea.ac.kr
12. IPD Sharing Statement
Plan to Share IPD
No
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A Clinical Trial to Verify the Efficacy and Safety of Electric Phlegm Suction System
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