Re-Evaluation of Systemic Early Neuromuscular Blockade and Transthoracic Ultrasound Assessment of the Diaphragm (ROSETTA)
研究概览
详细说明
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.
研究类型
联系人和位置
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02115
- Brigham and Women's Health
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Springfield、Massachusetts、美国、01199
- Baystate Health
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Ohio
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Cleveland、Ohio、美国、44195
- Cleveland Clinic
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Columbus、Ohio、美国、43210
- The Ohio State University Wexner Medical Center
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Oregon
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Portland、Oregon、美国、97239
- Oregon Health & Science University
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Tennessee
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Nashville、Tennessee、美国、37232
- Vanderbilt University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
1. 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)
Exclusion Criteria:
- 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)
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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Patients with moderate or severe ARDS
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Study feasibility - number of participating centers
大体时间:Through study completion, an average of 18 months
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The number of centers that participate in the study
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Through study completion, an average of 18 months
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Study feasibility - number of trained sonographers in study
大体时间:Through study completion, an average of 18 months
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The number of trained sonographers who collect measurements with ultrasound in the study
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Through study completion, an average of 18 months
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Study feasibility - enrolment rate
大体时间:Through study completion, an average of 18 months
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Percentage of potentially eligible patients in ROSE trial who are enrolled in ROSETTA
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Through study completion, an average of 18 months
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Study feasibility - measurement acquisition rate
大体时间:Through study completion, an average of 18 months
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Percentage of scheduled study measurements that are actually collected
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Through study completion, an average of 18 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Diaphragm function
大体时间:Study day 7
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Maximal diaphragm thickening fraction
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Study day 7
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Changes in diaphragm thickness over time with or without neuromuscular blockade
大体时间:First week of study
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First week of study
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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