Mechanical VentilationEOTEOMASENCT06631716
To Assess the Effectiveness of Three Distinct Mechanical Assisted Sputum Evacuation Apparatuses in the Treatment of Patients With Mechanical Ventilation-induced Atelectasis
An observational study of Mechanical Ventilation and Atelectasis, run by Sir Run Run Shaw Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Atelectasis
- What is being tested?
- CVT, HFCWO and MetaNeb
- Type of treatment
- Medical device
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 1 Dec 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- ≥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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Mechanical Ventilation, Atelectasis
- Being tested
- CVT, HFCWO, MetaNeb
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVTDevice
During mechanical ventilation, patients with atelectasis confirmed by chest CT, chest X-ray or lung ultrasound should be treated with mechanical assisted sputum evacuation, and the mechanical assisted sputum evacuation equipment used is CVT.
HFCWODevice
During mechanical ventilation, patients with atelectasis confirmed by chest CT, chest X-ray or lung ultrasound should be treated with mechanical assisted sputum evacuation, and the mechanical assisted sputum evacuation equipment used is HFCWO.
MetaNebDevice
During mechanical ventilation, patients with atelectasis confirmed by chest CT, chest X-ray or lung ultrasound should be treated with mechanical assisted sputum evacuation, and the mechanical assisted sputum evacuation equipment used is MetaNeb.
What is being measured
The primary outcome is the main question the study is designed to answer.
CT
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.
Measured: From enrollment to the end of treatment at 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631716
- Sponsor's protocol ID
- 2024-2037-02
- Acronym
- EOTEOMASE
- Status last verified
- Oct 2024
- First submitted
- 1 Sep 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Mechanically Assisted Sputum Excretion
- ClinicalTrials.gov ID
- NCT06631716
- Acronym / sponsor ID
- EOTEOMASE / 2024-2037-02
- Conditions
- Mechanical Ventilation, Atelectasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- ≥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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CVTDuring mechanical ventilation, patients with atelectasis confirmed by chest CT, chest X-ray or lung ultrasound should be treated with mechanical assisted sputum evacuation, and the mechanical assisted sputum evacuation equipment used is CVT. | Device | – |
| HFCWODuring mechanical ventilation, patients with atelectasis confirmed by chest CT, chest X-ray or lung ultrasound should be treated with mechanical assisted sputum evacuation, and the mechanical assisted sputum evacuation equipment used is HFCWO. | Device | – |
| MetaNebDuring mechanical ventilation, patients with atelectasis confirmed by chest CT, chest X-ray or lung ultrasound should be treated with mechanical assisted sputum evacuation, and the mechanical assisted sputum evacuation equipment used is MetaNeb. | Device | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation and Atelectasis, run by Sir Run Run Shaw Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Limin Yang (18268076196, yanglimin1214@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CT (time frame: From enrollment to the end of treatment at 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.