To Assess the Effectiveness of Three Distinct Mechanical Assisted Sputum Evacuation Apparatuses in the Treatment of Patients With Mechanical Ventilation-induced Atelectasis (EOTEOMASE)

October 6, 2024 updated by: Sir Run Run Shaw Hospital

Evaluation of the Effectiveness of Mechanically Assisted Sputum Excretion

Retention of airway secretions is a common clinical problem in patients with mechanical ventilation. Effective removal of airway secretions requires a balance between the production and removal of airway secretions through the mucociliary transport system. Effective removal of airway secretions is the basic measure to maintain airway patency and normal alveolar ventilation and oxygenation. At present, a variety of mechanical assisted expectoration devices have been used to remove airway secretions in critically ill patients, including The MetaNeb® System(MetaNeb), High Frequency Chest Wall Oscillation(HFCWO) and (Cycloid Vibration Therapy)CVT. However, there is still a lack of sufficient evidence to evaluate the clinical efficacy of these three different mechanical assisted expectoration devices in airway management of patients with mechanical ventilation. This study aims to observe the clinical efficacy of three different mechanical assisted sputum evacuation devices in airway management of patients with mechanical ventilation atelectasis, and to provide a basis for optimizing the airway management scheme of patients with mechanical ventilation.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

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

Name: Yang Limin Yang
Phone Number: 18268076196
Email: yanglimin1214@163.com

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

Adult
Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients who were more than 18 years old, with invasive mechanical ventilation for more than 48 hours and atelectasis confirmed by chest CT, chest X-ray or lung ultrasound in Sir Run Run Shaw Hospital, Zhejiang University School of Medicine were enrolled.

Description

Inclusion Criteria:

≥18 years old.
patients who were diagnosed as obstructed airway secretion clearance and required mechanical sputum evacuation in Sir Run Run Shaw Hospital, Zhejiang University School of Medicine. Among them, patients using CVT were included in the CVT cohort, patients using Metaneb were included in the Metaneb cohort, and patients using high-frequency chest wall oscillation (HFCWO) were included in the high-frequency chest wall oscillation (HFCWO) cohort.
voluntarily participated in this study and signed the informed consent. If the subjects were unable to read and sign the informed consent form due to incapacity or other reasons, their guardians were required to act for them during the informed consent process and sign the informed consent form. If the subjects were unable to read the informed consent form (e.g., illiterate subjects), witnesses were required to witness the informed consent process and sign the informed consent.
Invasive mechanical ventilation ≥48 hours.
Atelectasis was confirmed by chest CT, chest X-ray or lung ultrasound.

Exclusion Criteria:

BMI≥40kg/m2.
Severe spinal and thoracic deformity.
Known or suspected diaphragmatic dysfunction such as phrenic nerve rupture, neuromuscular disease, etc.
untreated tension pneumothorax.
Active bleeding in the lung.
Severe hemodynamic instability (increased dose of vasoactive drugs within 2 hours or MAP≤65mmHg).
Severe other organ dysfunction was expected to result in short-term death (7 days) or palliative treatment.
Other reasons considered by the medical team not suitable for treatment.
Pregnancy status.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CT Time Frame: From enrollment to the end of treatment at 5 days	3D Slicer 5.0.3 software was used to import the chest CT data set, which consisted of 1.25mm thick continuous CT slices obtained by a multi-slice spiral CT scanner under a conventional dose protocol (120Kv,150mA, pitch 1.0), and then the ''Lung CT Segment'' extension program was used. The lung regions were segmented by manually marking 13 marker points. After marking, all the lung regions were visually displayed, and then the region range was manually corrected using the tools selected in the ''Segment editor''. The ''Lung CT Analyzer'' extension program was then used to quantify the lung zones of ''hyperventilation'', ''normal ventilation'', ''hypoventilation'', and ''no ventilation'', and the proportion of no ventilation areas was obtained by software analysis.	From enrollment to the end of treatment at 5 days

Collaborators and Investigators

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

Sponsor

Sir Run Run Shaw Hospital

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 (Estimated)

November 1, 2024

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

September 1, 2024

First Submitted That Met QC Criteria

October 6, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)