对大型随机注册试验研究计划的协议和统计分析计划,比较在ICU (Mega-ROX) 接受无计划侵入性机械通风的成年人中保守与自由的氧化目标
Paul J Young1,2,3,4, Yaseen M Arabi5,6, Sean M Bagshaw7
1Intensive Care Unit, Wellington Hospital, Wellington, New Zealand.
在Mega-ROX试验中,将在需要机械通风的重症成年人中比较保守与自由的氧气治疗. 这项大型研究旨在确定最佳的氧气策略,以减少90天住院死亡率.
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 临床试验
背景情况:
- 对于在机械通风上治疗重症患者的最佳氧气疗法存在不确定性.
- 巨型ROX试验旨在通过比较保守和自由的氧气策略来解决这一问题.
研究的目的:
- 概述Mega-ROX试验的协议和统计分析计划.
- 为指导这项大规模随机注册试验的执行和解释.
主要方法:
- 一个平行组,注册表嵌入的临床试验,涉及40,000名成人ICU患者,需要无计划的侵入性机械通风.
- 随机分配给保守或自由的氧气疗法.
- 三个嵌套的随机对照试验专注于特定的患者亚组 (心脏骤停,败血症,急性脑损伤).
主要成果:
- 主要结局是90天住院全因死亡率.
- 二次结果包括生存时间,机械通风时间,以及ICU和住院时间.
结论:
- 巨大的ROX将提供关键的证据,在机械通风的ICU患者中,保守的与自由的氧气治疗的比较有效性.
- 报告协议和分析计划可以提高透明度,减轻偏见.
更多相关视频
08:35Oxygenation-sensitive Cardiac MRI with Vasoactive Breathing Maneuvers for the Non-invasive Assessment of Coronary Microvascular Dysfunction
Published on: August 17, 2022
10:38Observational Study Protocol for Repeated Clinical Examination and Critical Care Ultrasonography Within the Simple Intensive Care Studies
Published on: January 16, 2019
相关概念视频
Physiological Control of Respiration
Breathing, a seemingly passive process, is regulated by the respiratory center in the brainstem. This center coordinates the involuntary control of respirations, which means it occurs without conscious effort, ensuring a smooth and uninterrupted pattern.
Regulation of Ventilation
The body maintains ventilation by monitoring levels of carbon dioxide (CO2), oxygen (O2), and hydrogen ion concentration (pH) in the arterial blood. Among these factors, the level of CO2 plays a crucial...
Mechanical Ventilation I: Indication and Settings
Administering Oxygen by Mask
Administering oxygen by mask is a common nursing intervention that provides supplemental oxygen to patients with respiratory distress or chronic lung conditions. This procedure involves delivering oxygen at a specified rate through a face mask connected to an oxygen source.
Equipment
The equipment necessary for this procedure includes:
Acute Respiratory Failure-V
Ensure that patients are monitored continuously for their response to therapy, including changes in...
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...
Oxygen Delivering System II: Venturi Mask and Transtracheal Oxygen
Venturi Mask
The Venturi mask, named after the Venturi effect, is designed to deliver precise oxygen concentrations. It consists of a large tube with an oxygen inlet that narrows down, causing a pressure drop that pulls air in through adjustable side ports. The mask is a lightweight,...
