Study protocol: The Improving Care of Acute Lung Injury Patients ICAP studyReport as inadecuate




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Critical Care

, 10:R9

First Online: 16 December 2005Received: 03 November 2005Accepted: 16 November 2005

Abstract

IntroductionThe 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.

MethodsConsecutive 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.

ResultsOn 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.

ConclusionThe 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.

AbbreviationsALI= acute lung injury

ARDS= acute respiratory distress syndrome

ICAP= Improving Care of ALI Patients

ICU= intensive care unit

LTVV= lower tidal volume ventilation

QOL= quality of life

RASS= Richmond Agitation–Sedation Scale

SF-36= Medical Outcomes Study Short Form 36-Item Health Survey.

Electronic supplementary materialThe online version of this article doi:10.1186-cc3948 contains supplementary material, which is available to authorized users.

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Author: Dale M Needham - Cheryl R Dennison - David W Dowdy - Pedro A Mendez-Tellez - Nancy Ciesla - Sanjay V Desai - Jonathan 

Source: https://link.springer.com/



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