A Novel ECCO2R Device as a Lung Protective Measure in Hypercapnic Respiratory Failure: a Prospective Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Survival
研究概览
简要总结
The objective of this study is to assess the efficacy and safety of this new Prismalung+ membrane in its intended clinical setting by demonstrating a reduction in ventilatory parameters and pulmonary energy load or the successful maintenance of spontaneous breathing, respectively, the absence of the need to initiate vv-ECMO therapy, and initial survival.
详细描述
Our hypotheses are that decarboxylation therapy by means of the novel Prismalung+ membrane in patients with hypercapnic respiratory failure (I) allows the reduction of tidal volume, peak airway pressure, dP and pulmonary energy load (as measured by AUC over 72 hours) as compared to baseline in mechanically ventilated patients OR is associated with successful continuation of spontaneous breathing despite respiratory exhaustion (no decision to intubate), and that these patients (II) warrant no decision to initiate vv-ECMO therapy and (III) do not experience early mortality.
The primary Objectives of the study are to test our hypotheses I to III by applying the novel Prismalung+ ECCO2R device in mechanically ventilated patients and spontaneously breathing patients experiencing hypercapnic respiratory failure in a multi-central prospective trial in three experienced intensive care units in Switzerland.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mechanically ventilated patient: (I) Progressive respiratory failure (pH≤7.25 and/ or PaCO2 ≥9 kPa) during mechanical ventilation (II) with an inability to maintain lung protective ventilation (VT<4 mL/kg, Ppeak <30 mbar, Driving Pressure ≤12 mbar)
- •OR awake spontaneously breathing patient: Respiratory exhaustion (pH≤7.25 and/or PaCO2 ≥9 kPa)
- •AND Informed Consent as documented by signature
排除标准
- •Mechanical Ventilation group: Need for v-v ECMO
- •Awake spontaneously breathing group: Need for mechanical ventilation due to inability to remain un-sedated
- •Thrombocytopenia (<100G/l)
- •Contraindications for Heparin therapy (history of heparin antibodies, previous history of intracranial bleeding)
- •Patients under 18 years of age
- •Women who are pregnant or breast feeding
- •Previous enrolment into the current study
- •Enrolment of the investigator, his/her family members, employees and other dependent persons
结局指标
主要结局
Survival
时间窗: At timepoint 2 (28 days)
Survival
Driving Pressure
时间窗: At timepoint 1 (72 hours)
Driving Pressure \[mbar\] in mechanically ventilated patients or no intubation in spontaneously breathing patients
VV-ECMO therapy
时间窗: At timepoint 2 (28 days)
No initiation of VV-ECMO therapy
Tidal volume
时间窗: At timepoint 1 (72 hours)
Tidal volume (VT \[mL/kg\]) in mechanically ventilated patients or no intubation in spontaneously breathing patients
Peak Pressure
时间窗: At timepoint 1 (72 hours)
Peak Pressure (Ppeak \[mbar\]) in mechanically ventilated patients or no intubation in spontaneously breathing patients
次要结局
- Secondary endpoint - respiratory mechanics(72 hours)
- Secondary endpoint - complications(28 days)
研究者
Matthias Hilty
PD Dr. med. Matthias Hilty
University of Zurich