临床试验重症期间的通风方式 (MODE) 的协议和统计分析计划
Kevin P Seitz1, Bradley D Lloyd1, Li Wang1
1Department of Medicine (K. P. S., E. T. Q., T. W. R., M. W. S., and J. D. C.), Division of Allergy, Pulmonary and Critical Care Medicine; the Department of Emergency Medicine (B. D. L. and W. H. S.); the Department of Biostatistics (L. W. and M. S. S.); the Department of Respiratory Care (R. K. R., J. C. R., V. H.-W., C. E. S., W. D. R., T. M., A. N. T., P. G. H., and T. P. R.); the Department of Pharmaceutical Services (J. L. S.); the Department of Medicine (E. M. T., D. J. K., and B. D.), Vanderbilt University Medical Center, Nashville, TN; the Section on Pulmonary, Critical Care, Allergy, and Immunology (K. W. G.), Wake Forest School of Medicine, Winston-Salem, NC; the Vanderbilt Institute for Clinical and Translational Research (W. H. S.), Vanderbilt University Medical Center, Nashville, TN; the Department of Medicine, Division of General Internal Medicine and Public Health (A. S. M.), Vanderbilt University Medical Center, Nashville, TN; and the VA Tennessee Valley Healthcare System, Geriatric Research, Education, and Clinical Center (A. S. M.), Nashville, TN.
这项试点试验旨在调查不同的机械通风模式是否会影响患者的康复. 这项研究比较了体积控制,压力控制和适应性压力控制,以确定严重病患者的最佳设置.
科学领域:
- 关键护理医学 关键护理医学
- 呼吸系统疗法 呼吸系统疗法
- 临床试验方法论 临床试验方法论
背景情况:
- 机械通风对于严重病情的成年人来说至关重要,但最佳模式的选择仍然不清楚.
- 临床医生必须在体积控制,压力控制或较新的混合通风模式之间进行选择.
- 低潮水量和平原压力策略改善了结果,但目前尚不清楚实现这一目标的最佳方式.
研究的目的:
- 评估集群随机试验设计是否可以确定强制通风模式对患者康复的影响.
- 评估不同通风模式对严重病情的成年人无呼吸器日的影响.
主要方法:
- 危急疾病期间通风方式 (MODE) 试验是一个集群随机化,多重交叉试点研究.
- 它比较了体积控制,压力控制和适应式压力控制通风模式.
- 主要结局是入学后28天内没有使用呼吸机的日子.
主要成果:
- 本稿详细介绍了MODE试验的协议和统计分析计划.
- 它概述了三种不同的通风机模式的比较:体积控制,压力控制和自适应式压力控制.
结论:
- 在招生前规定一个完整的统计分析计划可以提高试验的严格性,可重现性和透明度.
- 该MODE试验协议已注册 (NCT05563779),并于2022年11月开始注册.
更多相关视频
06:22Surfactant Depletion Combined with Injurious Ventilation Results in a Reproducible Model of the Acute Respiratory Distress Syndrome ARDS
Published on: April 7, 2021
08:59Method of Isolated Ex Vivo Lung Perfusion in a Rat Model: Lessons Learned from Developing a Rat EVLP Program
Published on: February 25, 2015
相关概念视频
Mechanical Ventilation I: Indication and Settings
Ventilatory Modes
There are three ventilatory modes: full support, partial support, and spontaneous. These are described below.
Full Support Modes
Full support modes include controlled mechanical ventilation, continuous mandatory...
Acute Respiratory Failure-V
Ensure that patients are monitored continuously for their response to therapy, including changes in...
Assessment of Ventilation I: Respiratory Rate
A Ventilation assessment is critical for monitoring a patient's health status. Respiration, one of the most accessible vital signs, provides insights into the function of numerous body systems and can indicate serious health issues, such as brainstem injuries from head trauma.
Critical Guidelines for Assessing Ventilation:
Mechanical Ventilation II: Invasive Ventilation
Negative-Pressure Ventilators
Negative-pressure ventilators create a vacuum around the chest or body to draw air into the lungs, simulating breathing. This method does not require an...
Mechanical Ventilation III: Noninvasive Ventilation
Noninvasive Positive-Pressure Ventilation...
