倾向和振荡儿科临床试验协议 (PROSpect)
Martin C J Kneyber1,2, Ira M Cheifetz3, Lisa A Asaro4
1Division of Pediatric Critical Care Medicine, Department of Pediatrics, Beatrix Children's Hospital, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
概括
这项研究调查了儿童急性呼吸困扰综合征 (PARDS) 的倾斜定位 (PP) 和高频振荡通风 (HFOV). 结果将为这些关键呼吸系统管理策略指导临床实践.
科学领域:
- 关键护理医学 关键护理医学
- 儿科肺病学 儿科肺病学
- 临床试验方法论 临床试验方法论
背景情况:
- 目前针对儿科急性呼吸困扰综合征 (PARDS) 的呼吸管理主要是支持性.
- 仅有有限的数据可以指导人们在仰卧和俯卧 (PP) 或常规机械通风 (CMV) 和高频振荡通风 (HFOV) 之间做出选择.
研究的目的:
- 为了比较倾斜定位 (PP) 与躺卧定位和高频振荡通风 (HFOV) 与常规机械通风 (CMV) 的疗效,在患有中度至重度PARDS的儿科患者中.
- 为重症儿童的呼吸管理策略提供基于证据的指导.
主要方法:
- 一个全球性的,多中心的,二对二因数的,响应适应的随机受控试验 (PROSpect),涉及大约60个PICU.
- 患有中度至重度PARDS的儿科患者 (≥2周大) 被随机分配到四种手臂之一:卧卧/CMV,卧卧/CMV,卧卧/HFOV或卧卧/HFOV.
- 假设:与标准护理相比,PP或HFOV将导致至少2个额外的无呼吸器日 (VFD).
主要成果:
- 主要结局是无呼吸器日 (VFD) 到28日,非幸存者没有接受任何VFD.
- 二次结局包括无非肺器官衰竭日,90天死亡率和PICU后的功能状态.
- 适应性随机化将根据累积的试验数据调整治疗分配概率.
结论:
- 该PROSpect试验旨在产生关键数据,以告知临床决策与易感定位和高频振荡通风在PARDS.
- 这些发现将支持基于证据的呼吸护理,用于PARDS的重症儿童.
相关概念视频
Clinical Trials
8.5K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
There are four phases in a clinical trial. A phase one...
8.5K
Clinical Trials: Overview
4.7K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
4.7K
Preclinical Development: Overview
4.8K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
4.8K
Bioavailability Study Design: Healthy Subjects Versus Patients
252
Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
252


