Non-Invasive Dynamic Monitoring-Guided Oscillation and Lung Expansion for Airway Clearance in Sev… (NCT07432048) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Non-Invasive Dynamic Monitoring-Guided Oscillation and Lung Expansion for Airway Clearance in Severe Blunt Chest Trauma: A Clinical Study
80 participantsStarted 2026-03
Plain-language summary
In our previous study, the investigators analyzed more than 30,000 cases from the National Trauma Center Database and found that 66.4% of patients with severe blunt chest trauma had concurrent rib fractures, 55.87% had multiple fractures (≥4 ribs), and 37.4% had combined pulmonary contusion. In a further prospective observational cohort study evaluating the efficacy of EIT-guided OLE in such patients, results demonstrated that this protocol improved the ventilation-perfusion ratio and oxygenation index and shortened total mechanical ventilation duration. Based on literature review and preliminary findings, the investigators propose the following hypothesis: the application of EIT-noninvasively monitored OLE airway clearance in patients with severe blunt chest trauma can improve the ventilation-perfusion ratio, shorten mechanical ventilation time, reduce the incidence of complications such as pulmonary infection and mortality, and decrease medical resource consumption.
This study will verify this hypothesis through a prospective randomized controlled trial and further refine the specific implementation protocol of OLE to enhance its scientific validity and clinical applicability.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Severe blunt chest trauma, defined as injury caused by blunt force such as chest impact or compression, with an Abbreviated Injury Scale (AIS) score of the chest ≥ 3
* Age 18 to 70 years
* Time from injury to enrollment \< 48 hours
* Receiving invasive mechanical ventilation, with duration of mechanical ventilation \< 24 hours
* Written informed consent signed by the patient or his/her legal representative
Exclusion Criteria:
* Combined penetrating chest trauma
* Perinatal women
* Inability of the patient to cooperate with examinations and treatment
* Contraindications to EIT monitoring, including implanted cardiac pacemaker, unhealed local skin wound after thoracic surgery, extensive subcutaneous emphysema of the chest, etc
* Contraindications to OLE therapy:
Hemodynamic instability (heart rate \< 60 beats/min or \> 130 beats/min; systolic blood pressure \< 90 mmHg or \> 180 mmHg; or mean arterial pressure \< 60 mmHg or \> 100 mmHg)
* Unstable angina pectoris or cardiac arrhythmia
* Intracranial pressure \> 20 mmHg
* Active bleeding
* Suspected or active hemoptysis
* Undrained pneumothorax
* Unstable deep vein thrombosis or pulmonary embolism
* Unstable spinal or long bone fractures
* Unstable head and neck injury
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cumulative total duration of the first mechanical ventilation (hours)
Timeframe: through study completion, an average of 1 year