A Clinical Trial to Verify the Efficacy and Safety of Electric Phlegm Suction System

Not Applicable

• Conditions: Other Specified Respiratory Disorders
• Interventions: Device: unmanned electric phlegm suction system procedure using an investigational device (LMECA.A1000); Procedure: Manual phlegm suction system

• Registration Number: NCT05236400
• Lead Sponsor: Lmeca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-11
• Study First Submitted QC: 2022-02-09
• Study First Posted: 2022-02-11
• Study Start: 2022-03-16
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-03
• Last Update Posted: 2022-04-05
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 148

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
unmanned electric phlegm suction system procedure using an investigational device (LMECA.A1000)	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.
Manual phlegm suction system	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (3)

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of

Korea University Ansan Hospital; 🇰🇷 Seoul, Korea, Republic of