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临床试验/NCT07432048
NCT07432048尚未招募不适用

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

Peking University People's Hospital0 个研究点目标入组 80 人开始时间: 2026年3月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
主要终点
Cumulative total duration of the first mechanical ventilation (hours)

研究概览

简要总结

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.

详细描述

Trauma is one of the top ten causes of death across all age groups, and among young adults under 45 years of age, trauma has remained the leading cause of death for nearly four decades. As a megacity, Beijing features complex traffic conditions and a dense population, resulting in a high incidence of multiple injuries such as traffic injuries and falls from height. Such trauma is often accompanied by multiple organ injuries, which not only makes treatment difficult and costly but also significantly increases the financial burden on families and causes losses in social productivity due to long-term rehabilitation requirements and loss of working capacity. Improving treatment protocols and promoting advanced technologies can improve patient survival and reduce the need for long-term care. Establishing an efficient prevention and treatment system helps reduce redundant consumption of medical resources, alleviate pressure on medical insurance funds, and thereby release more resources to support economic and livelihood development. Therefore, reducing trauma mortality in young and middle-aged adults plays a critical role in stabilizing the labor supply, promoting urban modernization, and implementing the Healthy China strategy.

More than one-quarter of trauma patients eventually die from chest trauma and its related complications . The risk of pulmonary infection in trauma patients is four times higher than that in non-trauma patients. Rib fractures, pulmonary contusion, hemothorax, and procedures such as closed thoracic drainage and endotracheal intubation are all important risk factors for pulmonary infection. In patients with severe blunt chest trauma, the proportion of fractures involving stable thoracic structures such as ribs and sternum can reach 36.1%. Such fractures not only cause severe pain but, more importantly, approximately 10% of patients may develop flail chest with paradoxical respiratory motion, which severely disrupts normal respiratory mechanics and impairs the patient's ability to clear the airway through active coughing.

The incidence of pulmonary contusion exceeds 70% in severely injured patients and accounts for more than 50% of all chest traumas, particularly in high-speed motor vehicle-related trauma-the predominant injury mechanism of trauma in China. Pulmonary contusion not only directly injures the lung parenchyma but, more crucially, significantly increases the risk of atelectasis when coexisting with flail chest. Atelectasis leads to local alveolar collapse, impaired gas exchange, and further deterioration of airway self-clearing capacity. Restrictive ventilatory disorders caused by atelectasis and flail chest, together with hemorrhage and exudation from pulmonary contusion, create a highly favorable environment for pulmonary infection. Studies have reported that the incidence of pulmonary infection in such patients can exceed 21%. Infection not only directly exacerbates respiratory failure but is also a key trigger for sepsis, acute respiratory distress syndrome (ARDS), and even multiple organ failure. These severe complications progress sequentially to form a fatal pathological cascade, markedly increasing the risk of death.

Therefore, in-depth research and establishment of an airway clearance protocol for patients with severe blunt chest trauma are critically important. Its core objective is to interrupt the fatal chain from rib fracture, pulmonary contusion, and atelectasis to severe infection and organ failure. By improving respiratory failure, ensuring systemic oxygen supply, supporting patients through the acute phase, and effectively preventing or treating complications such as pulmonary infection, the prognosis can be significantly improved, mortality reduced, and excessive consumption of medical resources decreased.Blunt chest trauma is mainly caused by high-speed motor vehicle crashes, occupational injuries, and falls from height. Injury often immediately damages bony structures including the ribs, sternum, scapula, and spine. The incidence of rib fractures among trauma admissions is as high as 10%. The vast majority of patients with rib fractures are prone to varying degrees of atelectasis due to pain and restricted thoracic movement. More than 30% develop secondary complications such as pulmonary infection, which becomes an important cause of death. Rib fractures not only induce severe pain-especially during deep breathing and coughing-but also severely impair chest wall mechanical stability, restrict respiratory excursion, reduce tidal volume, and weaken effective cough capacity. This mechanical dysfunction combined with pain suppresses ventilation, impairs airway clearance, leads to sputum retention, and significantly increases the risk of pulmonary infection and respiratory failure.

Currently, rib fractures are mainly managed conservatively. Multimodal analgesia (e.g., opioids or regional blocks) is commonly used in elderly patients; although pain is relieved, respiratory drive and cough reflex may be further suppressed. Surgical fixation may be considered in patients with flail chest or those under 65 years of age to enhance chest wall stability and reduce mortality. However, continuous airway clearance therapy is still required postoperatively; otherwise, complications such as ventilator-associated pneumonia, unplanned intubation, and prolonged ICU stay may still occur.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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

干预措施: Different therapeutic interventions (Other)

The control group received a conventional airway clearance therapy regimen.

干预措施: Different therapeutic interventions (Other)

结局指标

主要结局

Cumulative total duration of the first mechanical ventilation (hours)

时间窗: through study completion, an average of 1 year

次要结局

  • 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)
  • 90-day all-cause mortality(through study completion, an average of 1 year)
  • First successful weaning rate(through study completion, an average of 1 year)
  • total cost in icu(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Li Shu

associate professor

Peking University People's Hospital

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