Non-Invasive Dynamic Monitoring-Guided Oscillation and Lung Expansion for Airway Clearance in Severe Blunt Chest Trauma: A Clinical Study

NCT07432048 | Not Yet Recruiting

• 1 other identifier: RDL2025-21
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Blunt Chest Trauma

Keywords

blunt chest trauma; pulmonary contusion; oscillation and lung expansion; electrical Impedance Tomography

Outcome Measures

Primary Outcomes (1)

• Cumulative total duration of the first mechanical ventilation (hours)

  through study completion, an average of 1 year

Secondary Outcomes (8)

• Degree of improvement in ventilation/perfusion (V/Q) matching

  through study completion, an average of 1 year

• Incidence of ventilator-associated pneumonia (VAP) during ICU stay

  through study completion, an average of 1 year

• Length of ICU stay

  through study completion, an average of 1 year

• Length of total hospital stay

  through study completion, an average of 1 year

• 28-day all-cause mortality

  through study completion, an average of 1 year

Study Arms (2)

The intervention group received an OLE airway clearance therapy regimen guided by noninvasive monito

Other: Different therapeutic interventions

The control group received a conventional airway clearance therapy regimen.

Other: Different therapeutic interventions

Interventions

Different therapeutic interventions OTHER

Eligible patients who met the inclusion and exclusion criteria were randomly assigned to the intervention group and the control group at a 1:1 ratio. Intervention group: received OLE airway clearance therapy guided by noninvasive monitoring technology. Control group: received conventional airway clearance therapy, including routine suction via flexible bronchoscopy, etc.

The control group received a conventional airway clearance therapy regimen.; The intervention group received an OLE airway clearance therapy regimen guided by noninvasive monito

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

the cohort will be selected from a tertiary hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Officials

• Shu Li, doctor

  Peking University People's Hosptial

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shu Li, doctor

CONTACT

+86 010 8832 4480; lishu2401@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: February 8, 2026
• First Posted: February 25, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: starting 1 year after publication
• Access Criteria: The data used and/or analyzed during the current study are available from the Investigator on reasonable request.