Ultra-Low Tidal Volume Mechanical Ventilation in ARDS Through ECMO (ULTIMATE) Pilot Randomized Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 72
- 试验地点
- 14
- 主要终点
- Number of patients recruited for the study
研究概览
简要总结
Primary Research Question for the Full ULTIMATE Randomized Clinical Trial (RCT): What is the effect of ultra-protective ventilation facilitated by extracorporeal membrane oxygenation (ECMO) versus best current conventional ventilation (CV) on all-cause hospital mortality among patients with early moderate-severe acute respiratory distress syndrome (ARDS)?
Secondary Research Questions: Among patients with early moderate-severe ARDS, what is the effect of ultra-protective ventilation versus CV on: (1) duration of mechanical ventilation; (2) duration of ICU and hospital stay; (3) organ dysfunction; (4) barotrauma; and (5) mortality at other time-points (ICU discharge, 28-day, 60-day)?
The ULTIMATE Pilot Study: Before embarking on a definitive multinational trial to address the questions listed above, the ULTIMATE Pilot Study has these 3 specific feasibility objectives:
- To assess adherence to our explicit mechanical ventilation protocols, with particular focus on delivered tidal volumes in both groups;
- To estimate the rate of patient recruitment and understand barriers to recruitment; and
- To measure and understand the reasons for crossovers or rescue by ECMO in the control group.
In addition, we will monitor safety issues, recording serious adverse events in both groups.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Endotracheal mechanical ventilation for ≤ 5 days
- •Early moderate-severe ARDS (Berlin Definition) - all of the following conditions for ≤ 48 hours i. PaO2/FiO2 ≤200 with PEEP > 5 cmH2O ii. bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules iii. respiratory failure not fully explained by cardiac failure or fluid overload iv. within one week of a known insult of new or worsening respiratory symptoms
- •ARDS severity criterion - either 1 of:
- •PaO2/FiO2 ≤ 150 mm Hg, on PEEP ≥ 10 cm H2O and FiO2 ≥ 0.5
排除标准
- •Currently receiving any form of ECMO (e.g., venovenous, venoarterial, or hybrid configuration)
- •Chronic hypercapnic respiratory failure defined as PaCO2 > 60 mmHg in the outpatient setting
- •Home mechanical ventilation (non-invasive ventilation or via tracheotomy), not CPAP
- •Actual body weight exceeding 1 kg per centimeter of height
- •Severe hypoxemia with PaO2/FiO2 < 80 mmHg
- •Expected mechanical ventilation duration < 48 hours
- •Treating team is in the process of moving to a palliative mode of care
- •Moribund patient not expected to survive 24 hours despite ongoing life-sustaining therapies
- •Confirmed diffuse alveolar hemorrhage from vasculitis
- •Contraindications to limited anticoagulation (e.g., active GI bleeding, bleeding diathesis)
- •Pregnancy - due to unknown effects of PaCO2 changes on placental blood flow
结局指标
主要结局
Number of patients recruited for the study
时间窗: Through study completion, an average of 2 years
Patient accrual will be adequate if we recruit 72 patients from 12 sites over 1 year of enrolment
Proportion of patients adhering to the study protocol
时间窗: Through study completion, an average of 2 years
Adherence to our explicit ventilation protocols will be adequate if more than 80% of patients have fewer than 10% of monitored values as major protocol violations
Proportion of patients crossing over to VV ECMO
时间窗: Through study completion, an average of 2 years
The number of protocol withdrawals or off-protocol treatment with VV ECMO will be acceptable if fewer than 10% of patients crossover or receive VV ECMO, when not allowed by the protocol
次要结局
- Ventilator-free days(Up to 30 days)
- Length of stay(Through study completion, an average of 2 years)
- Number of patients with non-pulmonary organ dysfunction(Up to 30 days)
- Number of patients with barotrauma(Up to 30 days)
- Mortality(Through study completion, an average of 2 years)
- Health-related quality of life(At 6 months post-randomization)
研究者
Eddy Fan
Associate Professor
University of Toronto