Study protocol: the improving care of acute lung injury patients (ICAP) study

• Type of Material: Article
• Authors: Dale M Needham, Johns Hopkins University; Cheryl R Dennison, Johns Hopkins University; David W Dowdy, Johns Hopkins University; Pedro A Mendez-Tellez, Johns Hopkins University; Nancy Ciesla, Johns Hopkins University; Sanjay V Desai, Johns Hopkins University; Jonathan Sevransky, Emory University; Carl Shanholtz, University of Maryland; Daniel Scharfstein, Johns Hopkins University; Margaret S Herridge, University of Toronto; Peter J Pronovost, Johns Hopkins University
• Language: English
• Date: 2006-01-01
• Publisher: BioMed Central
• Publication Version: Final Published Version
• Copyright Statement: © 2005 Needham et al.; licensee BioMed Central Ltd.
• License: Creative Commons Attribution 2.0 Generic
• Final Published Version (URL): http://dx.doi.org/10.1186/cc3948
• Title of Journal or Parent Work: Critical Care
• ISSN: 1364-8535
• Volume: 10
• Issue: 1
• Start Page: R9
• End Page: R9
• Grant/Funding Information: DMN is supported by a Clinician-Scientist Award from the Canadian Institutes of Health Research, and a Detweiler Fellowship from the Royal College of Physicians and Surgeons of Canada.; This research is supported by National Institutes of Health (Acute Lung Injury SCCOR grant P050 HL 73994-01).; CRD is supported by a Mentored Patient-Oriented Research Career Development Award from the National Institutes of Health (K23 NR009193).; DWD is supported by a Medical Scientist Training Program Grant from the National Institutes of Health (award 5 T32 GMO7309).
• Keywords: QUALITY-OF-LIFE; CRITICAL CARE MEDICINE; CONSENSUS PANEL REPORT; INTENSIVE-CARE; Life Sciences & Biomedicine; UNIT SURVIVORS; CRITICALLY ILL PATIENTS; MECHANICALLY VENTILATED PATIENTS; AGITATION-SEDATION SCALE; General & Internal Medicine; PULMONARY-FUNCTION; STUDYING OUTCOMES; RESPIRATORY-DISTRESS-SYNDROME; Critical Care Medicine; Science & Technology
• Research Categories: Health Sciences, Nursing; Health Sciences, General; Health Sciences, Health Care Management

Abstract

Introduction: The short-term mortality benefit of lower tidal volume ventilation (LTVV) for patients with acute lung injury/acute respiratory distress syndrome (ALI/ARDS) has been demonstrated in a large, multi-center randomized trial. However, the impact of LTVV and other critical care therapies on the longer-term outcomes of ALI/ARDS survivors remains uncertain. The Improving Care of ALI Patients (ICAP) study is a multi-site, prospective cohort study that aims to evaluate the longer-term outcomes of ALI/ARDS survivors with a particular focus on the effect of LTVV and other critical care therapies. Methods: Consecutive mechanically ventilated ALI/ARDS patients from 11 intensive care units (ICUs) at four hospitals in the city of Baltimore, MD, USA, will be enrolled in a prospective cohort study. Exposures (patient-based, clinical management, and ICU organizational) will be comprehensively collected both at baseline and throughout patients' ICU stay. Outcomes, including mortality, organ impairment, functional status, and quality of life, will be assessed with the use of standardized surveys and testing at 3, 6, 12, and 24 months after ALI/ ARDS diagnosis. A multi-faceted retention strategy will be used to minimize participant loss to follow-up. Results: On the basis of the historical incidence of ALI/ARDS at the study sites, we expect to enroll 520 patients over two years. This projected sample size is more than double that of any published study of long-term outcomes in ALI/ARDS survivors, providing 86% power to detect a relative mortality hazard of 0.70 in patients receiving higher versus lower exposure to LTVV. The projected sample size also provides sufficient power to evaluate the association between a variety of other exposure and outcome variables, including quality of life. Conclusion: The ICAP study is a novel, prospective cohort study that will build on previous critical care research to improve our understanding of the longer-term impact of ALI/ARDS, LTVV and other aspects of critical care management. Given the paucity of information about the impact of interventions on long-term outcomes for survivors of critical illness, this study can provide important information to inform clinical practice.