Sigh Ventilation to Increase Ventilator-Free Days in Victims of Trauma at Risk for Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 524
- 试验地点
- 30
- 主要终点
- Ventilator-free Days (VFDs)
研究概览
简要总结
A randomized, concurrent controlled trial to assess if adding sigh breaths to usual invasive mechanical ventilation of victims of trauma who are at risk of developing ARDS will decrease the number of days they require invasive mechanical ventilation.
详细描述
Patients in intensive care units (ICUs) as a result of injuries resulting from penetrating or non-penetrating trauma who are intubated and receiving invasive mechanical ventilation will be randomized to either usual care or usual care with the addition of sigh breaths given once every 6 minutes. Patients will be randomized to one of the two study arms as soon as possible, but not longer than 24 hours after initiation of invasive mechanical ventilation. Patients will be followed for 28 days to assess ventilator-free days (VFDs), mortality, ICU-free days, and the occurrence of complications.
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in an intensive care unit (ICU) as a result of injuries resulting from penetrating or non-penetrating trauma who are intubated and receiving invasive mechanical ventilation who also have one or more of the following:
- •Traumatic brain injury
- •> 1 long bone fractures
- •Shock on arrival in the Emergency Department (systolic BP < 90 mmHg)
- •Lung contusion
- •Receipt of > 6 units of blood
排除标准
- •Inability to obtain consent from the patient or his/her legally authorized representative (LAR)
- •Unwillingness of the treating physician to use sigh ventilation as all treating physicians must have equipoise with respect to the intervention
- •Age limitations per Institutional Review Board regulations
- •Undergoing invasive mechanical ventilation for > 24 hours, excluding any time during which the patient was being ventilated in the operating room, CT or IR, as this could represent too long a delay in instituting the intervention for it to have a chance of being effective
- •Presence of malignancy or other irreversible disease or condition for which the six month mortality is estimated to exceed 50% (e.g., chronic liver disease with a Child-Pugh Score of 10-15, malignancy refractory to treatment) as this could affect the clinical course and cloud interpretation of the endpoints
- •Women who are pregnant (negative pregnancy tests required on women of child-bearing age) per Human Subjects regulations
- •Prisoners, per Human Subjects regulations
- •Neurological condition that could impair spontaneous ventilation (e.g., C5 or higher spinal cord injury as this could affect the clinical course and cloud interpretation of the ventilator-free day endpoint
- •Lack of availability of Dräger Evita Infinity V500 ventilator as this is the only ventilator capable of delivering sigh breaths as described in the protocol
- •Burns > 40% of body surface area as this could affect the clinical course and cloud interpretation of the endpoints
- •Treating physicians being unwilling to use low VT ventilation strategy when ARDS is diagnosed as low VT ventilation is now considered standard of care for patients with ARDS.
- •Moribund, not expected to survive 24 hours as this could affect the clinical course and cloud interpretation of the endpoints
- •Treating physician's decision to use airway pressure release ventilation (APRV).
- •Patient not expected to require mechanical ventilation > 24 hours (e.g., intubated for alcohol intoxication rather than pulmonary problem).
结局指标
主要结局
Ventilator-free Days (VFDs)
时间窗: 28 days
Ventilator-free days (VFDs), defined as the number of days of unassisted breathing to day 28 without having to re-institute invasive ventilation. Patients who died before day 28 were assigned 0 VFDs as were those transferred to a long-term care facility while ventilated.
次要结局
- Number of Participants With Complications of Treatment(28 days)
- Discharge Status(28 days)
- All-cause Mortality(28 days)
- ICU-free Days(28 days)
- Number of Participants Requiring Oxygen Therapy at Discharge(28 days)