2/2 PROSpect: Prone and Oscillation Pediatric Clinical Trial (DCC)

2/2 PROSpect：俯卧和摆动儿科临床试验 (DCC)

• 批准号: 10219345
• 负责人: DAVID WYPIJ
• 金额: $ 63.12万
• 依托单位: BOSTON CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-06-15 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10219345
• 关键词: Adherence; Adult Respiratory Distress Syndrome; Back; Biometry; Boston; Cannulations; Cardiac Surgery procedures; Cardiology; Child; Childhood; Clinical; Clinical Trials; Clinical Trials Data Monitoring Committees; Critical Care; Critical Illness; Critically ill children; Data; Data Coordinating Center; Decision Making; Eligibility Determination; Enrollment; Extracorporeal Membrane Oxygenation; Frequencies; Futility; High-Frequency Ventilation; Hospitals; Hour; Human Resources; Hypercapnia; Hypoxia; Inferior; Intention; International; Intervention; Intratracheal Intubation; Length of Stay; Life; Lung diseases; Mechanical ventilation; Methodology; Mission; Modernization; Monitor; National Heart, Lung, and Blood Institute; Outcome; Paper; Patient-Focused Outcomes; Patients; Pediatric Acute Respiratory Distress Syndrome; Pediatric Hospitals; Pediatric Intensive Care Units; Probability; Procedures; Process; Prone Position; Protocols documentation; Randomized; Randomized Controlled Clinical Trials; Reporting; Research; Research Personnel; Safety; Statistical Data Interpretation; Strategic Planning; Supination; Update; Ventilator; Work; age group; archive data; clinical practice; data archive; data management; experience; follow-up; functional status; health related quality of life; improved; lung injury; meetings; patient safety; performance site; primary outcome; response; risk benefit ratio; ventilation

Project Summary Although pediatric acute respiratory distress syndrome (PARDS) is a life-threatening and frequent problem experienced by thousands of children each year, little evidence supports best ventilation practices. For 25 years, pediatric critical care clinicians have debated the risk-benefit ratio of supine versus prone positioning and conventional mechanical ventilation (CMV) versus high-frequency oscillatory ventilation (HFOV). The purpose of the proposed clinical trial PROSpect (PRone and OScillation PEdiatric Clinical Trial) is to provide evidence to support best ventilation practices in critically ill children with severe PARDS. The proposed study is a two-by-two factorial, response-adaptive, randomized controlled clinical trial of supine/prone positioning and CMV/HFOV in 45 pediatric intensive care units (PICUs; 30 U.S., 15 international) with at least 5 years of experience with these interventions. Up to 1000 patients with severe PARDS will be randomized to one of four groups (supine/CMV; prone/CMV; supine/HFOV; prone/HFOV), stratified by age group (<1; 1-7; 8- 17 years) and direct/indirect lung injury. Response adaptive randomization will begin after 400 patients provide complete data on the primary outcome, ventilator-free days. Any group demonstrating inferiority at pre-planned randomization update analyses will be eliminated to increase allocation to the remaining groups. PROSpect will close enrollment when any one group demonstrates superiority or for futility in answering the research question. Data will be analyzed per intention-to-treat for the primary analyses and per-protocol received. In conjunction with the Clinical Coordinating Center, the PROSpect Data Coordinating Center (DCC) will achieve the launch, execution and completion of the proposed trial by accomplishing these specific aims (SA): SA1: To provide state-of-the-art data management and data monitoring processes for U.S. and international enrollment for PROSpect, for post-discharge follow-up and for eventual data archiving. SA2: To monitor study enrollment and progress, site performance, protocol adherence and patient safety in support of study coordination and Data and Safety Monitoring Board (DSMB) needs. SA3: To perform randomization update analyses to aid in decision-making regarding response adaptive randomization as well as interim analyses for review of outcomes and safety data for DSMB reports. SA4: To provide high-quality statistical analyses for primary and secondary study papers using modern statistical methodology and graphical procedures and to assist with the rapid dissemination of findings. This clinical trial will provide the definitive evidence necessary for the field to consider a major change in clinical practice in the care of critically ill children with severe PARDS.

项目概要 尽管小儿急性呼吸窘迫综合征 (PARDS) 是一个危及生命的常见问题 每年都有数千名儿童经历过，但几乎没有证据支持最佳通风实践。 25 人份 多年来，儿科重症监护临床医生一直在争论仰卧位与俯卧位的风险收益比 以及传统机械通气 (CMV) 与高频振荡通气 (HFOV) 的比较。 拟议的临床试验 PROSpect（PRone 和 OScillation PEdiatric 临床试验）的目的是 提供证据支持患有严重 PARDS 的危重儿童的最佳通气实践。拟议的 研究是一项针对仰卧/俯卧位的二乘二析因、反应适应性、随机对照临床试验 在 45 个儿科重症监护病房（PICU；30 个美国，15 个国际）中进行定位和 CMV/HFOV 至少 拥有 5 年这些干预措施的经验。多达 1000 名严重 PARDS 患者将被随机分配到 四组之一（仰卧/CMV；俯卧/CMV；仰卧/HFOV；俯卧/HFOV），按年龄组分层（<1；1-7；8- 17 岁）和直接/间接肺损伤。反应适应性随机化将在 400 名患者提供信息后开始 主要结果（无呼吸机天数）的完整数据。任何在预先计划中表现出自卑的群体 将取消随机更新分析，以增加对剩余组的分配。前景 当任何一组表现出优越性或回答研究无效时，将关闭注册 问题。将根据初步分析的意向治疗和收到的方案对数据进行分析。 PROSpect 数据协调中心 (DCC) 将与临床协调中心合作 通过实现以下具体目标 (SA) 来启动、执行和完成拟议试验： SA1：为美国和国际提供最先进的数据管理和数据监控流程 注册 PROSpect、出院后随访和最终数据存档。 SA2：监测研究注册和进展、中心表现、方案遵守情况和患者安全 支持研究协调以及数据和安全监测委员会 (DSMB) 的需求。 SA3：执行随机化更新分析以帮助做出有关响应自适应的决策 随机化以及中期分析，用于审查 DSMB 报告的结果和安全数据。 SA4：使用现代方法为小学和中学研究论文提供高质量的统计分析 统计方法和图形程序，并协助快速传播调查结果。 这项临床试验将为该领域考虑重大变革提供必要的明确证据 在临床实践中护理患有严重 PARDS 的危重儿童。