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Author Notes:

Corresponding author: Dale M Needham, dale.needham@utoronto.ca

All authors made substantial contribution to the study design and methods.

DS, DMN, DWD and PJP specifically contributed to the statistical methods and power calculations.

DMN and DWD drafted the manuscript and all other authors critically revised it for important intellectual content.

All authors approved the final version of the manuscript for publication.

The authors acknowledge Wes Ely MD MPH and Brenda Truman Pun RN MSN for advice about the assessment of patient sedation, delirium and long-term mental and cognitive functional outcomes.

The funding bodies had no role in the study design, manuscript writing or decision to submit the manuscript for publication.

The authors declare that they have no competing interests.


Research Funding:

This research is supported by National Institutes of Health (Acute Lung Injury SCCOR grant P050 HL 73994-01).

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.

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).


  • Science & Technology
  • Life Sciences & Biomedicine
  • Critical Care Medicine
  • General & Internal Medicine

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

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Journal Title:

Critical Care


Volume 10, Number 1


, Pages R9-R9

Type of Work:

Article | Final Publisher PDF


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.

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© 2005 Needham et al.; licensee BioMed Central Ltd.

This is an Open Access work distributed under the terms of the Creative Commons Attribution 2.0 Generic License (http://creativecommons.org/licenses/by/2.0/).

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