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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorPeking University People's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

the cohort will be selected from a tertiary hospital

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Different therapeutic interventions

    Other intervention

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: The intervention group received an OLE airway clearance therapy regimen guided by noninvasive monito1 intervention
Group B: The control group received a conventional airway clearance therapy regimen.1 intervention

Trial outcomes

Primary outcomes

1

Cumulative total duration of the first mechanical ventilation (hours)

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

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

Time frame
through study completion, an average of 1 year
2

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

Time frame
through study completion, an average of 1 year
3

Length of ICU stay

Time frame
through study completion, an average of 1 year
4

Length of total hospital stay

Time frame
through study completion, an average of 1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: