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）仍然是危重患者死亡和发病的重要原因。该提案的目标是在新英格兰建立一个创新的多学科临床研究联盟，以促进NHLBI PETAL网络的研究。我们将这个临床中心命名为急性肺损伤组新英格兰（align）。我们的调查员在重症监护研究方面有丰富的经验。首席研究员（PI） Jay Steingrub博士是一名重症监护医师，目前是马萨诸塞州斯普林菲尔德Baystate临床中心高效ARDS网络临床中心的PI和负责人。主要合作研究者Peter Hou博士是马萨诸塞州波士顿布里格姆妇女医院的急诊医学和重症监护医师。align临床中心（CC）的主要地点将是Baystate医疗中心（BMC），塔夫茨大学医学院西部校区及其最大的临床培训基地。align CC的研究人员提出了一个由四个医疗中心组成的小组，为PETAL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缅因州波特兰的一个地点为大量患者提供服务。这些医疗中心包括贝斯特医疗中心（马萨诸塞州斯普林菲尔德），布里格姆妇女医院（马萨诸塞州波士顿），塔夫茨医疗中心（马萨诸塞州波士顿）和缅因州医疗中心（缅因州波特兰），塔夫茨大学医学院的教学附属机构。这个由四个医疗中心组成的联盟已经建立了学术和/或研究联系。这些地点的研究者和协调员活跃在临床研究中，许多研究者在研究设计和实施中发挥领导作用。他们的专业知识和创新技能将用于PETAL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人员的合作努力，考虑到ALIGNE每年急诊科的总访问量超过275,000，每年有超过15,000名ICU住院患者，以及超过1,000例需要机械通气的肺炎病例，这四家医院的研究受试者招募可能会超过最低预期。获得大型招募库对于获得所需的样本量至关重要，以便为预防和治疗ARDS的复杂研究提供动力。这些医院所服务的社区和将要招募的受试者在民族、种族和社会经济方面是多样化的。该联盟将共同努力优化研究流程，以筛选、招募和保留招募的危重患者人群。我们将重点关注我们的临床研究人员和协调员在重症监护研究的各个方面的专业知识，以及他们对PETAL网络试验的预期贡献。我们提议的CC将涉及多个学科，包括参与机构的重症监护医学、急诊医学、肺病、医院医学、呼吸治疗和护理，并将维持由PETAL网络确定的绩效目标。