Hypersecretive Mechanically Ventilated PatientsNCT06675942
Evaluating the Short-term Efficacy of Two Oscillation Techniques in Hypersecretive Mechanically Ventilated Patients
A study testing Oscillation and Lung Expansion and High-frequency chest wall oscillation in people with Hypersecretive Mechanically Ventilated Patients, run by Capital Medical University at 1 site in China.
Trial summary
Although mechanical ventilation (MV) is life-saving, it is associated with several complications. The establishment of an artificial airway impairs the cough reflex and mucociliary function, leading to the accumulation of secretions in the tracheobronchial tree. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypersecretive Mechanically Ventilated Patients
- What is being tested?
- Oscillation and Lung Expansion and High-frequency chest wall oscillation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2024to 13 Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible participants were patients aged ≥18 years with airway hypersecretion, admitted to the ICU,
- Requiring more than 48 hours of MV.
Who cannot join
- Malignant arrhythmia
- Acute myocardial ischemia
- Pneumothorax, pulmonary bulla, barotrauma, or other lung diseases,
- Hemorrhagic disease or coagulation abnormalities with bleeding tendencies
- Skin trauma on the chest
- Pulmonary embolism
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- Presence of a permanent or temporary pacemaker
- Untreated spinal and rib fractures
- Any condition deemed inappropriate for study inclusion by the researchers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jingyi Ge contact
About this study
Official title: Evaluating the Short-term Efficacy of Two Oscillation Techniques in Hypersecretive Mechanically Ventilated Patients: a Randomized Crossover Trial
Although mechanical ventilation (MV) is life-saving, it is associated with several complications. The establishment of an artificial airway impairs the cough reflex and mucociliary function, leading to the accumulation of secretions in the tracheobronchial tree. This increases the risk of pneumonia and lung atelectasis. Usual care for mechanically ventilated patients includes airway suctioning via the tracheostomy tube, which clears only a limited portion of the airway and is ineffective at removing peripheral airway secretions.
To address this, airway clearance guidelines recommend various airway clearance techniques (ACTs) for mechanically ventilated patients to enhance mucus removal. However, the lack of standardized, effective evaluation criteria makes selecting the optimal ACT a challenge.
Read the detailed description
The aim of this randomized cross-over study was to compare the effectiveness of oscillation and lung expansion (OLE) versus high-frequency chest wall oscillation (HFCWO) on lung aeration and ventilation distribution, as assessed by EIT, in medically complex, hypersecretive patients with tracheostomy tubes requiring long-term mechanical ventilation (MV).
- Being tested
- Oscillation and Lung Expansion, High-frequency chest wall oscillation
- Keywords
- Mechanical ventilation, Oscillation and Lung Expansion, High-frequency chest wall oscillation, Electrical impedance tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oscillation and Lung ExpansionDevice
The OLE device (MetaNeb system) is a newer, noninvasive physiotherapy tool that combines mechanical and pharmacological interventions (aerosols) to help mobilize endobronchial secretions.
High-frequency chest wall oscillationDevice
High-frequency chest wall oscillation (HFCWO) is an airway clearance technique that uses external forces applied to the chest via an inflatable vest connected to a device that generates vibrations at varying frequencies and pressures.
| Study group | Role | What they receive |
|---|---|---|
| Oscillation and Lung Expansion | Experimental | Not described Receives: Device: Oscillation and Lung Expansion; Device: High-frequency chest wall oscillation |
| High-frequency chest wall oscillation | Experimental | Not described Receives: Device: Oscillation and Lung Expansion; Device: High-frequency chest wall oscillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
End-expiratory lung impedance (EELI)
Measured: at the end of treatment (T1) and at 1 hour (T2), 2 hours (T3), 4 hours (T4)
Secondary outcomes (4)
Tidal impedance variation (TV)
Measured: at the end of treatment (T1) and at 1 hour (T2), 2 hours (T3), 4 hours (T4)
sputum volume
Measured: at the end of treatment (T1) and at 1 hour (T2), 2 hours (T3), 4 hours (T4)
Respiratory rate
Measured: at the end of treatment (T1) and at 1 hour (T2), 2 hours (T3), 4 hours (T4)
center of ventilation (COV)
Measured: at the end of treatment (T1) and at 1 hour (T2), 2 hours (T3), 4 hours (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start10 Nov 2024
- Primary completion2 Dec 2024
- Study completion13 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypersecretive Mechanically Ventilated PatientsStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingyi Ge, Capital Medical University
- Investigators
- Jingyi Ge, Principal investigator, Beijing Rehabilitation Hospital of Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675942
- Sponsor's protocol ID
- 12300126
- Status last verified
- Jan 2025
- First submitted
- 4 Nov 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Short-term Efficacy of Two Oscillation Techniques in Hypersecretive Mechanically Ventilated Patients: a Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT06675942
- Acronym / sponsor ID
- 12300126
- Keywords
- Mechanical ventilation, Oscillation and Lung Expansion, High-frequency chest wall oscillation, Electrical impedance tomography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 10 Nov 2024 (actual)
- Primary completion
- 2 Dec 2024 (actual)
- Study completion
- 13 Feb 2025 (estimated)
- First posted
- 6 Nov 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.
Although mechanical ventilation (MV) is life-saving, it is associated with several complications. The establishment of an artificial airway impairs the cough reflex and mucociliary function, leading to the accumulation of secretions in the tracheobronchial tree. This increases the risk of pneumonia and lung atelectasis. Usual care for mechanically ventilated patients includes airway suctioning via the tracheostomy tube, which clears only a limited portion of the airway and is ineffective at removing peripheral airway secretions.
To address this, airway clearance guidelines recommend various airway clearance techniques (ACTs) for mechanically ventilated patients to enhance mucus removal. However, the lack of standardized, effective evaluation criteria makes selecting the optimal ACT a challenge.
Detailed description
The aim of this randomized cross-over study was to compare the effectiveness of oscillation and lung expansion (OLE) versus high-frequency chest wall oscillation (HFCWO) on lung aeration and ventilation distribution, as assessed by EIT, in medically complex, hypersecretive patients with tracheostomy tubes requiring long-term mechanical ventilation (MV).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oscillation and Lung Expansion | Experimental | Device: Oscillation and Lung Expansion, Device: High-frequency chest wall oscillation |
| High-frequency chest wall oscillation | Experimental | Device: Oscillation and Lung Expansion, Device: High-frequency chest wall oscillation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Eligible participants were patients aged ≥18 years with airway hypersecretion, admitted to the ICU,
- Requiring more than 48 hours of MV.
Key exclusion criteria (9 listed)
- Malignant arrhythmia
- Acute myocardial ischemia
- Pneumothorax, pulmonary bulla, barotrauma, or other lung diseases,
- Hemorrhagic disease or coagulation abnormalities with bleeding tendencies
- Skin trauma on the chest
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 |
|---|---|---|
| Oscillation and Lung ExpansionThe OLE device (MetaNeb system) is a newer, noninvasive physiotherapy tool that combines mechanical and pharmacological interventions (aerosols) to help mobilize endobronchial secretions. | Device | High-frequency chest wall oscillation, Oscillation and Lung Expansion |
| High-frequency chest wall oscillationHigh-frequency chest wall oscillation (HFCWO) is an airway clearance technique that uses external forces applied to the chest via an inflatable vest connected to a device that generates vibrations at varying frequencies and pressures. | Device | High-frequency chest wall oscillation, Oscillation and Lung Expansion |
Primary outcome
End-expiratory lung impedance (EELI)
Time frame: at the end of treatment (T1) and at 1 hour (T2), 2 hours (T3), 4 hours (T4)
4 secondary outcomes
Tidal impedance variation (TV)
Time frame: at the end of treatment (T1) and at 1 hour (T2), 2 hours (T3), 4 hours (T4)
sputum volume
Time frame: at the end of treatment (T1) and at 1 hour (T2), 2 hours (T3), 4 hours (T4)
Respiratory rate
Time frame: at the end of treatment (T1) and at 1 hour (T2), 2 hours (T3), 4 hours (T4)
center of ventilation (COV)
Time frame: at the end of treatment (T1) and at 1 hour (T2), 2 hours (T3), 4 hours (T4)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
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.
Jingyi Ge contact
Jingyi Ge principal investigator
Beijing Rehabilitation Hospital of Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oscillation and Lung Expansion and High-frequency chest wall oscillation in people with Hypersecretive Mechanically Ventilated Patients, run by Capital Medical University at 1 site in China.
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 2 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: looking for participants now, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingyi Ge (ge_jingyi2020@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
End-expiratory lung impedance (EELI) (time frame: at the end of treatment (T1) and at 1 hour (T2), 2 hours (T3), 4 hours (T4)). 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 22 Jan 2025.