Early Non-invasive Ventilation and High-flow Nasal Oxygen Therapy for Preventing Delayed Respiratory Failure in Hypoxemic Blunt Chest Trauma Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 27
- 主要终点
- Necessity to perform endotracheal intubation
研究概览
简要总结
In blunt chest trauma patients without immediate life-threatening conditions, delayed respiratory failure and need for mechanical ventilation may still occur in 12 to 40% of patients, depending on the severity of the trauma, the preexisting conditions and the intensity of initial management.
In this context, non-invasive ventilation (NIV) is recommended in hypoxemic chest trauma patients, defined as a PaO2/FiO2 ratio < 200 mmHg. However, there is a large heterogeneity among studies regarding the severity of injuries, the degree of hypoxemia and the timing of enrollment. The interest of a preventive strategy during the early phase of blunt chest trauma, before the occurrence of respiratory distress or severe hypoxemia, is not formally established in the literature. Moreover, high-flow nasal oxygen therapy (HFNC-O2) appears to be a reliable and better tolerated alternative to conventional oxygen therapy (COT), associated with a significant reduction in intubation rate in hypoxemic patients.
Two NIV strategies are compared:
- In the experimental strategy, NIV is performed after inclusion in patients with moderate hypoxemia, defined by a PaO2/FiO2 ratio < 300 mmHg. The minimally required duration of NIV was 4 hours per day for at least 2 calendar days.
- In the control group, patients receive oxygen from nasal cannula or high concentration oxygen mask according to the FiO2 needed to achieve SpO2 > 92%. NIV is initiated only in patients having PaO2/FiO2 ratio < 200 mmHg under COT.
Investigators hypothesized that an early strategy associating HFNC-O2 and preventive NIV in hypoxemic blunt chest trauma patients may reduce the need for mechanical ventilation compared to the recommended strategy associating COT and late NIV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient admitted in intensive care unit within 48 hours after a high-risk blunt chest trauma, defined by a TTS (Thorax Trauma Severity) score ≥
- •Hypoxemia defined by a PaO2/FiO2 ratio < 300, and the absence of hypercapnia (PaCO2 < 45 mmHg).
- •Without indication of endotracheal intubation at inclusion.
- •Affiliated person or beneficiary of a social security scheme.
- •Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
排除标准
- •Criteria relating to formal indication to NIV: Exacerbation of underlying chronic respiratory disease, cardiogenic pulmonary edema, severe neutropenia.
- •Criteria relating to contraindications to NIV: Hemodynamic instability, Glasgow Coma Scale score ≤ 12 or excessive agitation, or other contraindications to non-invasive ventilation (active gastrointestinal bleeding, low level of consciousness, multiorgan failure, airway patency problems, lack of cooperation or hemodynamic instability).
- •Associated traumatic lesions entailing particular risks: severe brain injury, complex facial trauma, tetraplegia, tracheobronchial or esophageal injuries, thoracic or abdominal trauma with indication for surgery by thoracotomy or laparotomy.
- •Criteria relating to the regulation: A do-not-intubate order and a decision not to participate, persons placed under judicial protection, persons participating in another research including a period of exclusion still in course, severely altered physical and/or psychological health which, according to the investigator, could affect the participant's compliance of the study.
研究组 & 干预措施
An "early" NIV strategy associated with HFNC-O2
干预措施: Preventive strategy (Combination Product)
A "late" NIV strategy associated with COT
干预措施: Standard of care (Combination Product)
结局指标
主要结局
Necessity to perform endotracheal intubation
时间窗: Up to 14 days after randomization
To ensure the consistency of indications across sites and reduce the risk of delayed intubation, the following criteria for endotracheal intubation must be used (only one criterion is needed): cardiac arrest or significant hemodynamic instability, deterioration of neurologic status, signs of persisting or worsening respiratory failure as defined by at least two of the following criteria: respiratory rate of more than 35 breaths per minute, lack of improvement in signs of high respiratory-muscle workload, development of copious tracheal secretions, signs of respiratory exhaustion (pH \<7.32 or PaCO2 \> 50 mmHg), major hypoxemia (PaO2/FiO2 ratio \<100 or SpO2 \<92% for more than 5 minutes).
次要结局
- Dyspnea score(every 6 hours during the first 48 hours after randomization)
- ICU and hospital length of stay(Up to 14 days after randomization)
- ICU or in-hospital mortality(Up to 14 days after randomization)
- Number of ventilator free-days(Up to 14 days after randomization)
- PaO2/FiO2 ratio(every 6 hours during the first 48 hours after randomization)
- Respiratory rate(every 6 hours during the first 48 hours after randomization)