Los Angeles Center of the Collaborative Pediatric Critical Care Research Network

洛杉矶儿科重症监护协作研究网络中心

• 批准号: 8854802
• 负责人: CHRISTOPHER JOHN NEWTH
• 金额: $ 1.65万
• 依托单位: CHILDREN'S HOSPITAL OF LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-05-01 至 2015-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8854802
• 关键词: Accounting; Acute Lung Injury; Address; Adherence; Adult; Adult Respiratory Distress Syndrome; Affect; Alveolar; Area; Benefits and Risks; Breathing; California; Cardiac Output; Caring; Case Report Form; Cessation of life; Characteristics; Chest wall structure; Child; Child health care; Childhood; Clinical; Clinical Trials; Computers; Consensus; Critical Care; Critically ill children; Data; Data Collection; Development; Dose; Edema; Enrollment; Ensure; Environment; Environmental air flow; Exhalation; Fluid Balance; Fluid overload; Goals; Growth; Guidelines; Hour; Human Development; Hypoxemia; Individual; Infant; Informatics; Institutes; Institution; Investigation; Lead; Leadership; Length; Liquid substance; Location; Los Angeles; Lung; Measurement; Measures; Mechanical ventilation; Methods; Modification; Morbidity - disease rate; Obesity; Outcome; Oxygen; Patients; Pediatric Hospitals; Pharmaceutical Preparations; Physiological; Physiology; Pleural; Positive-Pressure Respiration; Prone Position; Protocol Compliance; Protocols documentation; Research; Research Personnel; Resolution; Respiratory physiology; Resuscitation; Risk; Safety; Sedation procedure; Sepsis Syndrome; Severities; Structure; Surrogate Endpoint; Therapeutic; Tidal Volume; Time; Titrations; Tube; Universities; Validation; Variant; Ventilator; Work of Breathing; arm; base; clinical research site; clinically significant; data management; endotracheal; esophagus pressure; evidence base; experience; expiration; hemodynamics; improved; indexing; lung basal segment; lung injury; member; mortality; patient population; population based; pressure; public health relevance; racial and ethnic; research and development; symposium; tool

 DESCRIPTION (provided by applicant): The Los Angeles Center has made substantial contributions to the goals of CPCCRN and its growth. Our particular strengths include: 1) high enrollment in studies, 2) rich racial and ethnic mixture of children, 3) broad experience in informatics, data management and computer-based decision support (CDS) tools, and 4) unique expertise in mechanical ventilation and respiratory physiology. These make us an ideal setting for Network studies. Studies by the ARDSNet and other groups in adult patients have demonstrated that the choice of PEEP can affect mortality, both for better and worse. Little is known about methods of PEEP application in children, especially in the face of obesity and fluid overload, common problems in the PICU. The purpose of this study is to compare two Positive End-Expiratory Pressure / Inspired Oxygen (PEEP/FiO2) ventilator management strategies on optimal lung recruitment and oxygenation in infants and children with pediatric Acute Respiratory Distress Syndrome (PARDS). This has not been done previously in children. The study will compare the use of esophageal pressure recordings to individualize PEEP/FiO2 application by measuring transpulmonary pressure at end-expiration against the CPCCRN pediatric modification of the ARDS Network protocolized, population-based PEEP/FiO2 application tables. It will also address hemodynamic safety concerns by measuring cardiac output non-invasively. Computer-based Decision Support (CDS) tools already developed within CPCCRN under the leadership of the Los Angeles Center will be used in both arms. This will improve protocol adherence and ensure replicable clinical decisions for equivalent patient states to minimize confounding ventilator management variations at each clinical site. In order to overcome limitations highlighted in previous trials on PARDS, non-invasive markers of lung injury will be used both to improve patient enrollment and to characterize risk, following the guidelines of the Pediatric Acute Lung Injury Consensus Conference (PALICC). Two members of the Los Angeles Center participated in their development. We believe our concept proposal is best suited for the CPCCRN research environment as it is the only structured research environment where the detailed data and number of patients needed for this study can be obtained in a reasonable time. Moreover, the study builds upon the Los Angeles Center's previous CPCCRN research and development.

 描述（由申请人提供）：洛杉矶中心为CPCCRN的目标及其发展做出了重大贡献。我们的优势包括：1）研究的高入学率，2）儿童的丰富种族和民族混合，3）在信息学，数据管理和基于计算机的决策支持（CDS）工具方面的广泛经验，以及4）在机械通气和呼吸生理学方面的独特专业知识。这使我们成为网络研究的理想场所。ARDSNet和其他团体在成人患者中进行的研究表明，PEEP的选择可以影响死亡率，无论是好是坏。关于PEEP在儿童中的应用方法知之甚少，特别是面对肥胖和液体过载，这是PICU中的常见问题。本研究的目的是比较两种呼气末正压/吸入氧（PEEP/FiO 2）呼吸机管理策略对小儿急性呼吸窘迫综合征（PARDS）婴儿和儿童最佳肺复张和氧合的影响。这在以前的儿童中是没有的。本研究将比较使用食管压力记录，通过测量呼气末的经肺动脉压与CPCCRN对ARDS网络协议化的基于人群的PEEP/FiO 2应用表的儿科修改，来个性化PEEP/FiO 2应用。它还将通过无创测量心输出量来解决血流动力学安全性问题。在洛杉矶中心的领导下，CPCCRN内部已经开发了基于计算机的决策支持工具，这些工具将用于两个武器。这将提高方案依从性，并确保相同患者状态的可复制临床决策，以最大限度地减少每个临床研究中心的混淆呼吸机管理变化。为了克服先前PARDS试验中突出的局限性，将根据儿科急性肺损伤共识会议（PALICC）的指南，使用非侵入性肺损伤标志物来改善患者入组和表征风险。洛杉矶中心的两名成员参与了其开发工作。我们相信我们的概念提案最适合CPCCRN研究环境，因为它是唯一一个结构化的研究环境，可以在合理的时间内获得本研究所需的详细数据和患者数量。此外，该研究建立在洛杉矶中心以前的CPCCRN研究和开发的基础上。