Reduction of Blood Recirculation in Veno-Venous ECMO Through Ultrasound Dilution Measurements (ECMO Circulation Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Successful ECMO blood flow reduction
研究概览
简要总结
Blood which recirculates through the circuit of a veno-venous Extracorporeal Membrane Oxygenation (V-V ECMO) does not contribute to the systemic oxygenation of a patient on V-V ECMO and is called the recirculation fraction (Rf). Theoretically, the optimization of ECMO blood flow is possible using Rf measurements.
A prospective, observational study will be performed measuring the Rf of total ECMO blood flow in patients with acute respiratory distress syndrome (ARDS) on V-V ECMO with an ultrasound dilution technique.
ECMO blood flow will be optimized by reducing ECMO blood flow in accordance with the measured Rf as long as systemic oxygenation is not compromised.
详细描述
Based on data from the 'Blood Recirculation and vvECMO' trial (ClinicalTrials.gov ID: NCT03200314) (i.e. an expected frequency of successful blood flow reduction of 66.7%), using a one-sample Chi square test, a two-sided type-1 error of 5%, a power of 80%, a total of 68 patients is needed to show that the proportion of patients with a secure ECMO blood flow reduction is greater than 50%. Presumably, 136 Patients have to be included into the trial to study 68 patients with a relevant Rf since not all patients on V-V ECMO suffer from a high Rf.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Successful ECMO blood flow reduction
时间窗: Once within the first week after initiation of ECMO therapy
Number of patients with a relevant recirculation fraction and successful ECMO blood flow reduction
次要结局
- Recirculation fraction(Once within the first week after initiation of ECMO therapy)
- Arterial blood oxygen content(Once within the first week after initiation of ECMO therapy)
- Extracorporeal blood Flow(Once within the first week after initiation of ECMO therapy)
- Extracorporeal gas flow(Once within the first week after initiation of ECMO therapy)
- Length of ECMO therapy(Daily until the end of ECMO therapy (approximately 14 days))
- Cannula position and distance(Once within the first week after initiation of ECMO therapy)
- Right heart dysfunction(Once within the first week after initiation of ECMO therapy)
- Length of mechanical ventilation(Entire duration of the ICU stay (approximately 28 days))
- Complications of ECMO therapy(Length of ECMO therapy (approximately 14 days))
- ICU mortality(Entire duration of the ICU stay (approximately 28 days))
- ICU length of stay(Entire duration of the ICU stay (approximately 28 days))
- Incidence of ICU-acquired organ dysfunctions and complications(Entire duration of the ICU stay (approximately 28 days))
- ECMO blood flow over time(Daily until the end of ECMO therapy (approximately 14 days))
- ECMO sweep gas flow over time(Daily until the end of ECMO therapy (approximately 14 days))
- Mobility at ICU discharge(Discharge from the ICU (approximately 28 days))
- Weaning level at ICU discharge(Discharge from the ICU (approximately 28 days))
- Status of mechanical ventilation at ICU discharge(Discharge from the ICU (approximately 28 days))
- Level of organ dysfunction at ICU discharge(Discharge from the ICU (approximately 28 days))
- Level of consciousness at ICU discharge(Discharge from the ICU (approximately 28 days))
- Level of disease severity(Discharge from the ICU (approximately 28 days))
- Hospital acquired infections related to ECMO therapy(Entire duration of ECMO therapy)
- Bleeding and thrombembolic complications of ECMO therapy(Entire duration of ECMO therapy)
研究者
Steffen Weber-Carstens
Prof. Dr. med.
Charite University, Berlin, Germany