Acute Lung Injury Group New England Program to Support PETAL Network Research

急性肺损伤小组新英格兰计划支持 PETAL 网络研究

• 批准号: 8703389
• 负责人: JAY S STEINGRUB
• 金额: $ 14.38万
• 依托单位: BAYSTATE MEDICAL CENTER, INC.
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-06-17 至 2021-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8703389
• 关键词: Accident and Emergency department; Active Sites; Acute Lung Injury; Acute respiratory failure; Admission activity; Adult Respiratory Distress Syndrome; Adverse effects; Berlin; Biological Markers; Boston; Breathing; Carbon Monoxide; Caring; Clinical; Clinical Research; Clinical Trials; Clinical trial protocol document; Commit; Communities; Complex; Conduct Clinical Trials; Contracts; Critical Care; Critical Illness; Data; Data Quality; Development; Discipline; Discipline of Nursing; Disease; Dose; Early identification; Educational process of instructing; Emergency Medicine; Enrollment; Environmental air flow; Epidemiology; Goals; Hospital Mortality; Hospitalists; Hospitalization; Hospitals; Incidence; Inflammatory; Institutes; Institution; Intensive Care Units; Intervention; Lead; Leadership; Lung; Lung diseases; Maine; Massachusetts; Mechanical ventilation; Medical center; Medicine; Modality; Modeling; Monitor; Morbidity - disease rate; Names; National Heart, Lung, and Blood Institute; New England; Outcome; Patients; Pattern; Performance; Physicians; Physiological; Pneumonia; Population; Prevention; Principal Investigator; Process; Protocol Compliance; Recruitment Activity; Reporting; Research; Research Design; Research Infrastructure; Research Personnel; Research Subject Recruitments; Resources; Respiratory Therapy; Review Committee; Risk; Role; Sample Size; Screening procedure; Site; Surgical Intensive Care; Teaching Hospitals; Therapeutic Uses; Time; Training; Universities; Visit; Woman; Work; clinical effect; college; data management; design; expectation; experience; health care delivery; high risk; human subject protection; improved; innovation; interest; loris; lung injury; medical schools; model development; mortality; multidisciplinary; patient population; preclinical study; programs; public health relevance; quality assurance; screening; skills; socioeconomics; therapy development

DESCRIPTION (provided by applicant): Acute respiratory distress syndrome (ARDS) remains a significant cause of mortality and morbidity in critically ill patients. The objective of this proposal is to develop an innovative and multidisciplinary clinical research consortium in New England to facilitate research by the NHLBI PETAL Network. We have named this Clinical Center Acute Lung Injury Group New England (ALIGNE). Our investigators have extensive experience in critical care research. The Principal Investigator (PI), Dr. Jay Steingrub, a critica care physician, is currently PI and leader of a highly productive ARDS Network Clinical Center, Baystate Clinical Center, in Springfield, MA. The key co-Investigator, Dr. Peter Hou, is an Emergency Medicine and critical care physician, at Brigham and Women's Hospital in Boston, MA. The primary site of the ALIGNE Clinical Center (CC) will be Baystate Medical Center (BMC), the Western Campus of Tufts University School of Medicine and its largest clinical training site. The investigators of ALIGNE CC put forward a group of four medical centers to conduct clinical trials for the PETAL Network. The four hospitals are tertiary referral centers, serving large populations of patients at three sites in Massachusetts and one site in Portland, ME. These medical centers include Baystate Medical Center (Springfield, MA), Brigham and Women's Hospital (Boston, MA), Tufts Medical Center (Boston, MA), and Maine Medical Center (Portland, ME), a teaching affiliate of Tufts University School of Medicine. This consortium of four medical centers has preexisting academic and/or research ties. Investigators and coordinators at these sites are active in clinical research, and many investigators have leadership roles in research design and conduct. Their expertise and innovative skills will be put to use for the PETAL Network to explore prevention and treatment modalities of ARDS. The two clinical trial protocols that we propose represent the collaborative efforts of these investigators Recruitment of research subjects at these four hospitals will likely exceed minimum expectations, given that total annual Emergency Department visits within ALIGNE exceed 275,000, with more than 15,000 annual ICU admissions, and more than 1,000 cases of pneumonia requiring mechanical ventilation. Access to a large recruitment pool is crucial for obtaining the sample sizes needed to power sophisticated studies into the prevention and treatment of ARDS. The communities served by these hospitals and the subjects to be recruited are diverse ethnically, racially, and socioeconomically. This consortium will work together to optimize research processes to screen, enroll, and retain a recruited population of critically ill patients. We will focus on the considerable expertise of our clinical researchers and coordinators in all aspects of critical care research, and their anticipated contribution to PETAL Network trials. Our proposed CC will engage multiple disciplines including Critical Care Medicine, Emergency Medicine, Pulmonary Diseases, Hospital Medicine, Respiratory Therapy, and Nursing at the participating institutions and will sustain performance goals determined by the PETAL Network.

描述（由申请人提供）：急性呼吸窘迫综合征（ARDS）仍然是重症患者死亡率和发病率的重要原因。该提案的目的是在新英格兰开发一个创新的多学科临床研究联盟，以促进NHLBI Petal网络的研究。我们已经命名了这个临床中心急性肺损伤组新英格兰（Aligne）。我们的研究人员在重症监护研究方面拥有丰富的经验。批评医生Jay Steingrub博士（PI）是PI，目前是马萨诸塞州斯普林菲尔德的Baystate临床中心的PI和高产ARDS网络临床中心的领导者。关键的共同研究人员Peter Hou博士是马萨诸塞州波士顿的Brigham和妇女医院的急诊医学和重症监护医师。 Aligne临床中心（CC）的主要地点是Baystate医疗中心（BMC），Tufts大学医学院西部校园及其最大的临床培训地点。 Aligne CC的研究人员提出了一个由四个医疗中心组成的小组，以为花瓣网络进行临床试验。这四家医院是三级转诊中心，在马萨诸塞州的三个地点和我的一个地点为大量患者提供服务。这些医疗中心包括Baystate医疗中心（马萨诸塞州斯普林菲尔德），杨百翰和妇女医院（马萨诸塞州波士顿），塔夫茨医学中心（马萨诸塞州波士顿）和缅因州医学中心（ME）（ME），塔夫茨大学医学院的教学分支机构。这个由四个医疗中心组成的联盟具有先前存在的学术和/或研究联系。这些站点的研究人员和协调员在临床研究中积极活跃，许多研究人员在研究设计和行为中都有领导作用。他们的专业知识和创新技能将用于花瓣网络，以探索ARDS的预防和治疗方式。我们提出的两项临床试验方案代表了这些研究者在这四家医院招募研究对象的合作努力，因为Aligne内的年度急诊室访问超过275,000，超过15,000次年度ICU招生，并且有1,000多例肺炎需要机械通风。获取大型招聘池对于获取为预防和治疗ARD的样本量所需的样本量至关重要。这些医院和要招募的学科服务的社区在种族，种族和社会经济上都是多样的。该财团将共同努力，以优化研究过程，以筛查，注册并保留招募重症患者的招募人群。我们将专注于重症监护研究各个方面的临床研究人员和协调员的大量专业知识，以及他们对花瓣网络试验的预期贡献。我们拟议的CC将在参与机构中参与多个学科，包括重症监护医学，急诊医学，肺部疾病，医院医学，呼吸疗法和护理，并维持Petal Network确定的绩效目标。