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

April 3, 2022 updated by: Lmeca

A Clinical Trial to Verify the Efficacy and Safety of Electric Phlegm Suction System: Prospective, Multi-center, Randomized, Open-label, Pivotal Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 08308
        • Recruiting
        • Korea University Guro Hospital
        • Contact:
      • Seoul, Korea, Republic of, 02841
      • Seoul, Korea, Republic of, 15355

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of airway mucosal damage change on 72 hours after application through bronchoscopy results
Time Frame: 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
72 hours after application of the investigational device

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of airway mucosal damage
Time Frame: 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
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
Time Frame: 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
For 2 weeks from the time of investigational device application
Rate of investigational device malfunction
Time Frame: 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
For 2 weeks from the time of application of investigational device

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lmeca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 16, 2022

Primary Completion (ANTICIPATED)

December 31, 2023

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

January 11, 2022

First Submitted That Met QC Criteria

February 9, 2022

First Posted (ACTUAL)

February 11, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 5, 2022

Last Update Submitted That Met QC Criteria

April 3, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LMECA.A1000.CIP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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