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.

项目摘要 尽管小儿急性呼吸窘迫综合征（PARS）是威胁生命且频繁的问题 每年有成千上万的儿童经历，很少有证据支持最佳通风习惯。 25 多年，小儿重症监护临床医生已经辩论了仰卧与俯卧位的风险效益比 以及常规的机械通气（CMV）与高频振荡通气（HFOV）。 拟议的临床试验前景（俯卧和振荡儿科临床试验）的目的是 提供证据以支持患有严重帕克的重症儿童的最佳通风习惯。提议 研究是仰卧/容易发生的两乘阶乘，反应自适应的随机对照临床试验 在45个儿科重症监护病房（PICUS; 30 U.S.，International）的定位和CMV/HFOV至少 这些干预措施有5年的经验。多达1000例严重pard的患者将被随机分为 四组（仰卧/CMV；俯卧/CMV；仰卧/HFOV；俯卧/HFOV），按年龄组进行分层（<1; 1-7; 8-- 17年）和直接/间接肺损伤。 400名患者提供后，应自适应随机分组 完整有关主要结果，无通风机的数据。任何在预先计划时表现出自卑的群体 将消除随机更新分析以增加对其余组的分配。前景 当任何一组表现出优势或徒劳的回答研究时，都会关闭入学 问题。将分析数据，以分析主要分析和每项协议的每个意向性治疗。 与临床协调中心一起，前景数据协调中心（DCC）将 通过完成这些特定目标（SA）来实现拟议试验的发布，执行和完成： SA1：为美国和国际提供最先进的数据管理和数据监视流程 潜在客户的入学率，放电后随访以及最终数据归档。 SA2：监视学习入学和进度，现场表现，协议依从性和患者安全 支持研究协调和数据和安全监控委员会（DSMB）的需求。 SA3：进行随机更新分析以帮助有关响应自适应的决策 随机分析以及临时分析，以审查DSMB报告的结果和安全数据。 SA4：使用现代研究论文提供高质量的统计分析 统计方法和图形程序，并有助于快速传播发现。 该临床试验将为该领域提供重大变化所需的确定证据 在临床实践中，患有严重帕克的重症儿童。