Re-Evaluation of Systemic Early Neuromuscular Blockade and Transthoracic Ultrasound Assessment of the Diaphragm
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 6
- 主要终点
- Study feasibility - enrolment rate
研究概览
简要总结
ROSETTA is a multi-centre study evaluating the time course of diaphragm thickness and function following exposure to neuromuscular blockade or control in patients with acute respiratory distress. ROSETTA is an ancillary study to the Re-evaluation of Systemic Early Neuromuscular Blockade (ROSE) trial (NCT02509078). It is designed to (1) test the feasibility of a multi-center evaluation of the diaphragm structure and function by ultrasound during mechanical ventilation and (2) determine whether neuromuscular blockade accelerates atrophy and dysfunction of the diaphragm in patients with acute respiratory distress syndrome (ARDS).
详细描述
A growing body of evidence strongly suggests that mechanical ventilation injures the respiratory muscles, particularly the diaphragm. Due to the deleterious effects of diaphragm inactivity on diaphragm function, there are important concerns about the risk of diaphragm weakness and difficult liberation from mechanical ventilation following neuromuscular blockade. Sonographic measurements of diaphragm thickness provide a potentially useful window for studying diaphragm injury and function during mechanical ventilation.
Patients enrolled in the ROSE trial (randomizing patients with moderate-severe acute respiratory distress syndrome to receive neuromuscular blockade or control for 2 days) will be eligible for participation in this study. Study patients will undergo regular diaphragm ultrasound to assess diaphragm thickness and activity during the first week of the study. Diaphragm function will be assessed by ultrasound on study days 7, 14, 21, and 28.
ROSETTA is designed to:
- Test the feasibility of a multi-center evaluation of the diaphragm structure and function by ultrasound during mechanical ventilation;
- Determine whether neuromuscular blockade accelerates atrophy and dysfunction of the diaphragm in patients with acute respiratory distress syndrome; and
- Evaluate whether patients with greater diaphragm dysfunction exhibit worse functional outcomes compared to patients without diaphragm dysfunction.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients enrolled in the ROSE PETAL trial (adult patients with moderate-severe acute respiratory distress syndrome who have received invasive mechanical ventilation for less than 5 days)
排除标准
- •Patients expected to be extubated within 24 hours of screening for eligibility
- •Patients with a contraindication to chest ultrasonography (chest tubes inserted over right lower chest wall; chest wall trauma)
结局指标
主要结局
Study feasibility - enrolment rate
时间窗: Through study completion, an average of 18 months
Percentage of potentially eligible patients in ROSE trial who are enrolled in ROSETTA
Study feasibility - measurement acquisition rate
时间窗: Through study completion, an average of 18 months
Percentage of scheduled study measurements that are actually collected
Study feasibility - number of participating centers
时间窗: Through study completion, an average of 18 months
The number of centers that participate in the study
Study feasibility - number of trained sonographers in study
时间窗: Through study completion, an average of 18 months
The number of trained sonographers who collect measurements with ultrasound in the study
次要结局
- Diaphragm function(Study day 7)
- Changes in diaphragm thickness over time with or without neuromuscular blockade(First week of study)