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. 2010 Apr 27:10:8.
doi: 10.1186/1471-227X-10-8.

Towards the prevention of acute lung injury: a population based cohort study protocol

Sweta J Thakur  1 , Cesar A Trillo-Alvarez, Michael M Malinchoc, Rahul Kashyap, Lokendra Thakur, Adil Ahmed, Martin K Reriani, Rodrigo Cartin-Ceba, Jeff A Sloan, Ognjen Gajic
Affiliations

Towards the prevention of acute lung injury: a population based cohort study protocol

Sweta J Thakur et al. BMC Emerg Med. .

Abstract

Background: Acute lung injury (ALI) is an example of a critical care syndrome with limited treatment options once the condition is fully established. Despite improved understanding of pathophysiology of ALI, the clinical impact has been limited to improvements in supportive treatment. On the other hand, little has been done on the prevention of ALI. Olmsted County, MN, geographically isolated from other urban areas offers the opportunity to study clinical pathogenesis of ALI in a search for potential prevention targets.

Methods/design: In this population-based observational cohort study, the investigators identify patients at high risk of ALI using the prediction model applied within the first six hours of hospital admission. Using a validated system-wide electronic surveillance, Olmsted County patients at risk are followed until ALI, death or hospital discharge. Detailed in-hospital (second hit) exposures and meaningful short and long term outcomes (quality-adjusted survival) are compared between ALI cases and high risk controls matched by age, gender and probability of developing ALI. Time sensitive biospecimens are collected for collaborative research studies. Nested case control comparison of 500 patients who developed ALI with 500 matched controls will provide an adequate power to determine significant differences in common hospital exposures and outcomes between the two groups.

Discussion: This population-based observational cohort study will identify patients at high risk early in the course of disease, the burden of ALI in the community, and the potential targets for future prevention trials.

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Figures

Figure 1
Figure 1
Proposed "two hit" model of ALI development: the window of opportunity exists for the potential ALI prevention strategies.
Figure 2
Figure 2
Outline of the study design.
Figure 3
Figure 3
Power for a matched case control study of 500 ALI patients matched to 500 controls where the risk factor occurs at 10%, 5%, or 1% prevalence in the controls and the false positive rate is 0.05. As depicted, if 5% of the controls experience delayed fluid resuscitation which increases the risk of ALI by 2 fold, then the study has about 82% power to reject the null hypothesis.
See this image and copyright information in PMC

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