Effect of Intermittent High Frequency Oscillatory Ventilation on the Pathophysiology and Survival of Patients With the Acute Respiratory Distress Syndrome.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 42
- 试验地点
- 4
- 主要终点
- Survival to hospital discharge
研究概览
简要总结
Based on recent two-center results (Eur Respir J. 2011 Sep 1. [Epub ahead of print] PMID: 21885390) we hypothesized that intermittent High-frequency oscillation (HFO) combined with Recruitment Maneuvers (RMs) may beneficially affect the pathophysiology and survival of patients with moderate-to-severe Acute Respiratory Distress Syndrome (ARDS).
Design: Randomized Controlled Trial. Intervention: Briefly, the HFO-RMs strategy of the intervention (HFO-RMs) group will comprise RMs (3/day) and an initial HFO session of 96 hours (HFO session can be interrupted before the 96-hour time point only if PaO2/FiO2 rises to >200 mmHg for >12 hours), followed by return to lung protective conventional mechanical ventilation (CMV) according to pre-specified oxygenation criteria. Within days 1-10 postrandomization, patients will be returned to HFO upon recurrence of their moderate-to-severe oxygenation disturbance. Patients of the control (CMV) group will receive lung protective CMV.
详细描述
BACKGROUND AND RATIONALE Recent two-center results (1) support a beneficial effect of combined high-frequency oscillation (HFO), recruitment maneuvers (RMs) and tracheal gas insufflation (TGI) on the survival of patients with severe acute respiratory distress syndrome (ARDS). The addition of TGI to HFO improves gas-exchange (1-4); however, its value with respect to outcome still remains uncertain (1). TGI is likely useful in patients with very severe oxygenation disturbances and/or poor tolerance to hypercapnia (2).
The main goals of the present study are 1) The determination of the effect of the intermittent, combined use of HFO and RMs (HFO-RMs - intervention group) on the survival as compared to the best possible strategy of lung-protective conventional mechanical ventilation (CMV - control group); and 2) the elucidation of the mechanism of action of HFO on respiratory function and the ARDS-related inflammatory response.
The consecutive hypotheses supporting the conduct of the present trial can be summarized as follows:
The use of HFO + RMs will likely augment lung recruitment, with consequent improvements in oxygenation and lung compliance The HFO-related, physiological benefits will likely be maintained during the subsequent CMV, if an adequate positive end-expiratory pressure (PEEP) level is used (1).
Therefore, the following sequence of events is expected from the intermittent use of HFO-RMs:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •early ARDS (establishment of the diagnosis within the preceding 72 hours) according to the criteria of the American-European Consensus Conference (5),
- •Moderate-to-severe oxygenation disturbance [defined as ratio of partial pressure of arterial oxygen (PaO2) to inspired oxygen fraction (FiO2)<200 mmHg, while being ventilated with positive end-expiratory pressure (PEEP) set at ≥10 cmH2O for at least 12 hours,
- •age 18-75 years, body weight >40 Kg,
排除标准
- •severe air leak (more than one chest tubes per hemithorax with persistent air leak for more than 72 hours),
- •systolic blood pressure lower than 90 mmHg and/or mean blood pressure lower than 65 mmHg, despite maximum support with fluids and vasopressor drugs (i.e., norepinephrine infusion rate exceeding 0.5 μg/kg/min,
- •significant heart disease (e.g. ejection fraction lower than 40%, history of pulmonary edema and active ischemic disease or myocardial infarction),
- •severe chronic obstructive pulmonary disease (COPD) or asthma (e.g. previous admission for COPD/asthma, chronic treatment with corticosteroids for COPD/asthma, and chronic CO2 retention more than 50 mmHg),
- •intracranial pathology with intracranial pressure >20 mmHg, not responsive to maximum conservative treatment (e.g. hemorrhage, head injury, tumor, infection or acute ischemic stroke),
- •chronic interstitial lung disease with bilateral lung infiltrates,
- •lung biopsy or incision during the current admission,
- •previous lung transplantation or bone marrow transplantation, i) pregnancy,
- •immunosuppression, and
- •participation in another clinical study.
结局指标
主要结局
Survival to hospital discharge
时间窗: 60-120 days
Patient discharged home while not requiring any form of ventilatory assistance.
次要结局
- The number of organ failure-free days until day 60 post-randomization(60 days)
- Inflammatory response(5 days)
- The number of ventilator-free days until day 60 post-randomization(60 days)
- Complications(60-120 days)
- Physiological variables during the study intervention period(10 days)
研究者
Spyros D. Mentzelopoulos
Assistant Professor in Intensive Care Medicine
University of Athens