Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Critical Care
Published in: Critical Care 1/2006

Open Access 01-02-2005 | Research

Study protocol: The Improving Care of Acute Lung Injury Patients (ICAP) study

Authors: Dale M Needham, Cheryl R Dennison, David W Dowdy, Pedro A Mendez-Tellez, Nancy Ciesla, Sanjay V Desai, Jonathan Sevransky, Carl Shanholtz, Daniel Scharfstein, Margaret S Herridge, Peter J Pronovost

Published in: Critical Care | Issue 1/2006

Login to get access

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.
Appendix
Available only for authorised users
Literature
1.
Ware LB, Matthay MA: The acute respiratory distress syndrome. N Engl J Med 2000, 342: 1334-1349. 10.1056/NEJM200005043421806CrossRefPubMed
2.
Rubenfeld GD, Angus DC, Pinsky MR, Curtis JR, Connors AF Jr, Bernard GR: Outcomes research in critical care: results of the American Thoracic Society Critical Care Assembly Workshop on Outcomes Research. The Members of the Outcomes Research Workshop. Am J Respir Crit Care Med 1999, 160: 358-367.CrossRefPubMed
3.
Angus DC, Carlet J: Surviving intensive care: a report from the 2002 Brussels Roundtable. Intensive Care Med 2003, 29: 368-377.PubMed
4.
Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A: Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. The Acute Respiratory Distress Syndrome Network. N Engl J Med 2000, 342: 1301-1308. 10.1056/NEJM200005043421801CrossRef
5.
Jackson JC, Gordon SM, Ely EW, Burger C, Hopkins RO: Research issues in the evaluation of cognitive impairment in intensive care unit survivors. Intensive Care Med 2004, 30: 2009-2016. 10.1007/s00134-004-2422-2CrossRefPubMed
6.
Needham DM, Pronovost PJ: Affordable health care. Crit Care Med 2004, 32: 2564.CrossRef
7.
Heyland DK, Groll D, Caeser M: Survivors of acute respiratory distress syndrome: relationship between pulmonary dysfunction and long-term health-related quality of life. Crit Care Med 2005, 33: 1549-1556. 10.1097/01.CCM.0000168609.98847.50CrossRefPubMed
8.
Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al-Saidi F, Cooper AB, Guest CB, Mazer CD, Mehta S, et al.: One-year outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med 2003, 348: 683-693. 10.1056/NEJMoa022450CrossRefPubMed
9.
Orme J Jr, Romney JS, Hopkins RO, Pope D, Chan KJ, Thomsen G, Crapo RO, Weaver LK: Pulmonary function and health-related quality of life in survivors of acute respiratory distress syndrome. Am J Respir Crit Care Med 2003, 167: 690-694. 10.1164/rccm.200206-542OCCrossRefPubMed
10.
Cooper AB, Ferguson ND, Hanly PJ, Meade MO, Kachura JR, Granton JT, Slutsky AS, Stewart TE: Long-term follow-up of survivors of acute lung injury: lack of effect of a ventilation strategy to prevent barotrauma. Crit Care Med 1999, 27: 2616-2621. 10.1097/00003246-199912000-00002CrossRefPubMed
11.
Petrucci N, Iacovelli W: Ventilation with lower tidal volumes versus traditional tidal volumes in adults for acute lung injury and acute respiratory distress syndrome. Cochrane Database Syst Rev 2004, CD003844.
12.
Schein RM, Quartin AA: Acute respiratory distress syndrome and long-term outcomes: what should we follow? Crit Care Med 2005, 33: 1656-1658. 10.1097/01.CCM.0000170176.22020.76CrossRefPubMed
13.
Bernard GR, Artigas A, Brigham KL, Carlet J, Falke K, Hudson L, Lamy M, Legall JR, Morris A, Spragg R: The American-European Consensus Conference on ARDS. Definitions, mechanisms, relevant outcomes, and clinical trial coordination. Am J Respir Crit Care Med 1994, 149: 818-824.CrossRefPubMed
14.
Needham DM, Dowdy DW, Mendez-Tellez PA, Herridge MS, Pronovost PJ: Studying outcomes of intensive care unit survivors: measuring exposures and outcomes. Intensive Care Med 2005, 31: 1153-1160. 10.1007/s00134-005-2656-7CrossRefPubMed
15.
van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R: Intensive insulin therapy in the critically ill patients. N Engl J Med 2001, 345: 1359-1367. 10.1056/NEJMoa011300CrossRefPubMed
16.
Dowdy DW, Needham DM, Mendez-Tellez PA, Herridge MS, Pronovost PJ: Studying outcomes of intensive care unit survivors: the role of the cohort study. Intensive Care Med 2005, 31: 914-921. 10.1007/s00134-005-2657-6CrossRefPubMed
17.
Amaravadi RK, Dimick JB, Pronovost PJ, Lipsett PA: ICU nurse-to-patient ratio is associated with complications and resource use after esophagectomy. Intensive Care Med 2000, 26: 1857-1862. 10.1007/s001340000720CrossRefPubMed
18.
Pronovost PJ, Jenckes MW, Dorman T, Garrett E, Breslow MJ, Rosenfeld BA, Lipsett PA, Bass E: Organizational characteristics of intensive care units related to outcomes of abdominal aortic surgery. JAMA 1999, 281: 1310-1317. 10.1001/jama.281.14.1310CrossRefPubMed
19.
Iapichino G, Radrizzani D, Pezzi A, Assi E, Di Mauro P, Mistraletti G, Porta F: Evaluating daily nursing use and needs in the intensive care unit: a method to assess the rate and appropriateness of ICU resource use. Health Policy 2005, 73: 228-234. 10.1016/j.healthpol.2004.11.015CrossRefPubMed
20.
Knaus WA, Draper EA, Wagner DP, Zimmerman JE: APACHE II: a severity of disease classification system. Crit Care Med 1985, 13: 818-829.CrossRefPubMed
21.
Charlson ME, Pompei P, Ales KL, MacKenzie CR: A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis 1987, 40: 373-383. 10.1016/0021-9681(87)90171-8CrossRefPubMed
22.
Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, Reinhart CK, Suter PM, Thijs LG: The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med 1996, 22: 707-710.CrossRefPubMed
23.
Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK: The Richmond Agitation–Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med 2002, 166: 1338-1344. 10.1164/rccm.2107138CrossRefPubMed
24.
Ely EW, Truman B, Shintani A, Thomason JW, Wheeler AP, Gordon S, Francis J, Speroff T, Gautam S, Margolin R, et al.: Monitoring sedation status over time in ICU patients: reliability and validity of the Richmond Agitation–Sedation Scale (RASS). JAMA 2003, 289: 2983-2991. 10.1001/jama.289.22.2983CrossRefPubMed
25.
Ely EW, Inouye SK, Bernard GR, Gordon S, Francis J, May L, Truman B, Speroff T, Gautam S, Margolin R, et al.: Delirium in mechanically ventilated patients: validity and reliability of the confusion assessment method for the intensive care unit (CAM-ICU). JAMA 2001, 286: 2703-2710. 10.1001/jama.286.21.2703CrossRefPubMed
26.
Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS: Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA 2004, 291: 1753-1762. 10.1001/jama.291.14.1753CrossRefPubMed
27.
Graf J, Koch M, Dujardin R, Kersten A, Janssens U: Health-related quality of life before, 1 month after, and 9 months after intensive care in medical cardiovascular and pulmonary patients. Crit Care Med 2003, 31: 2163-2169. 10.1097/01.CCM.0000079607.87009.3ACrossRefPubMed
28.
Ridley SA, Chrispin PS, Scotton H, Rogers J, Lloyd D: Changes in quality of life after intensive care: comparison with normal data. Anaesthesia 1997, 52: 195-202. 10.1111/j.1365-2044.1997.073-az0068.xCrossRefPubMed
29.
Wehler M, Geise A, Hadzionerovic D, Aljukic E, Reulbach U, Hahn EG, Strauss R: Health-related quality of life of patients with multiple organ dysfunction: individual changes and comparison with normative population. Crit Care Med 2003, 31: 1094-1101. 10.1097/01.CCM.0000059642.97686.8BCrossRefPubMed
30.
Hayes JA, Black NA, Jenkinson C, Young JD, Rowan KM, Daly K, Ridley S: Outcome measures for adult critical care: a systematic review. Health Technol Assess 2000, 4: 1-111.PubMed
31.
Chrispin PS, Scotton H, Rogers J, Lloyd D, Ridley SA: Short Form 36 in the intensive care unit: assessment of acceptability, reliability and validity of the questionnaire. Anaesthesia 1997, 52: 15-23. 10.1111/j.1365-2044.1997.015-az014.xCrossRefPubMed
32.
The EuroQol Group: EuroQol – a new facility for the measurement of health-related quality of life. Health Policy 1990, 16: 199-208. 10.1016/0168-8510(90)90421-9CrossRef
33.
Katz S, Ford AB, Moskowitz RW, Jackson BA, Jaffe MW: Studies of illness in the aged. The index of ADL: a standardized measure of biological and psychosocial function. JAMA 1963, 185: 914-919.CrossRefPubMed
34.
Lawton MP, Brody EM: Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist 1969, 9: 179-186.CrossRefPubMed
35.
Wallace KL, Middleton S, Cook IJ: Development and validation of a self-report symptom inventory to assess the severity of oral-pharyngeal dysphagia. Gastroenterology 2000, 118: 678-687. 10.1016/S0016-5085(00)70137-5CrossRefPubMed
36.
Newman CW, Weinstein BE, Jacobson GP, Hug GA: The Hearing Handicap Inventory for Adults: psychometric adequacy and audiometric correlates. Ear Hear 1990, 11: 430-433. 10.1097/00003446-199012000-00004CrossRefPubMed
37.
Lok J, Gill R, van der Vaart A, Robins J: Estimating the causal effect of a time-varying treatment on time-to-event using structural nested failure time models. Statistica Neerlandica 2004, 58: 271-295. 10.1111/j.1467-9574.2004.00123.xCrossRef
38.
Hayden D, Pauler DK, Schoenfeld D: An estimator for treatment comparisons among survivors in randomized trials. Biometrics 2005, 61: 305-310. 10.1111/j.0006-341X.2005.030227.xCrossRefPubMed
39.
Gilbert PB, Bosch RJ, Hudgens MG: Sensitivity analysis for the assessment of causal vaccine effects on viral load in HIV vaccine trials. Biometrics 2003, 59: 531-541. 10.1111/1541-0420.00063CrossRefPubMed
40.
Zhang JL, Rubin DB: Estimation of casual effects via principal stratification when some outcomes are truncated by death. Journal of Educational and Behavioral Statistics 2003, 28: 353-368.CrossRef
41.
Ostermann ME, Keenan SP, Seiferling RA, Sibbald WJ: Sedation in the intensive care unit: a systematic review. JAMA 2000, 283: 1451-1459. 10.1001/jama.283.11.1451CrossRefPubMed
42.
Pronovost PJ, Angus DC, Dorman T, Robinson KA, Dremsizov TT, Young TL: Physician staffing patterns and clinical outcomes in critically ill patients: a systematic review. JAMA 2002, 288: 2151-2162. 10.1001/jama.288.17.2151CrossRefPubMed
43.
Van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R: Intensive insulin therapy in the critically ill patients. N Engl J Med 2001, 345: 1359-1367. 10.1056/NEJMoa011300CrossRefPubMed
44.
Angus DC, Musthafa AA, Clermont G, Griffin MF, Linde-Zwirble WT, Dremsizov TT, Pinsky MR: Quality-adjusted survival in the first year after the acute respiratory distress syndrome. Am J Respir Crit Care Med 2001, 163: 1389-1394.CrossRefPubMed
45.
Hopkins RO, Weaver LK, Collingridge D, Parkinson RB, Chan KJ, Orme JF Jr: Two-year cognitive, emotional, and quality-of-life outcomes in acute respiratory distress syndrome. Am J Respir Crit Care Med 2005, 171: 340-347. 10.1164/rccm.200406-763OCCrossRefPubMed
46.
Wyrwich KW, Nelson HS, Tierney WM, Babu AN, Kroenke K, Wolinsky FD: Clinically important differences in health-related quality of life for patients with asthma: an expert consensus panel report. Ann Allergy Asthma Immunol 2003, 91: 148-153.CrossRefPubMed
47.
Wyrwich KW, Fihn SD, Tierney WM, Kroenke K, Babu AN, Wolinsky FD: Clinically important changes in health-related quality of life for patients with chronic obstructive pulmonary disease: an expert consensus panel report. J Gen Intern Med 2003, 18: 196-202. 10.1046/j.1525-1497.2003.20203.xPubMedCentralCrossRefPubMed
48.
Davidson TA, Caldwell ES, Curtis JR, Hudson LD, Steinberg KP: Reduced quality of life in survivors of acute respiratory distress syndrome compared with critically ill control patients. JAMA 1999, 281: 354-360. 10.1001/jama.281.4.354CrossRefPubMed
49.
Weinert CR, Gross CR, Kangas JR, Bury CL, Marinelli WA: Health-related quality of life after acute lung injury. Am J Respir Crit Care Med 1997, 156: 1120-1128.CrossRefPubMed
50.
Schelling G, Stoll C, Vogelmeier C, Hummel T, Behr J, Kapfhammer HP, Rothenhausler HB, Haller M, Durst K, Krauseneck T, Briegl J: Pulmonary function and health-related quality of life in a sample of long-term survivors of the acute respiratory distress syndrome. Intensive Care Med 2000, 26: 1304-1311. 10.1007/s001340051342CrossRefPubMed
51.
Ahdieh L, Gange SJ, Greenblatt R, Minkoff H, Anastos K, Young M, Nowicki M, Kovacs A, Cohen M, Munoz A: Selection by indication of potent antiretroviral therapy use in a large cohort of women infected with human immunodeficiency virus. Am J Epidemiol 2000, 152: 923-933. 10.1093/aje/152.10.923CrossRefPubMed
52.
Bernard GR, Vincent JL, Laterre PF, LaRosa SP, Dhainaut JF, Lopez-Rodriguez A, Steingrub JS, Garber GE, Helterbrand JD, Ely EW, et al.: Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med 2001, 344: 699-709. 10.1056/NEJM200103083441001CrossRefPubMed
53.
Ware JE Jr, Sherbourne CD: The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992, 30: 473-483. 10.1097/00005650-199206000-00002CrossRefPubMed
54.
Guyatt GH, Sullivan MJ, Thompson PJ, Fallen EL, Pugsley SO, Taylor DW, Berman LB: The 6-minute walk: a new measure of exercise capacity in patients with chronic heart failure. Can Med Assoc J 1985, 132: 919-923.PubMedCentralPubMed
55.
Weiss DS, Marmar CR: The Impact of Events Scale – Revised. In Assessing Psychological Trauma and PTSD. Edited by: Wilson JP, Keane TM. New York: Guilford Press; 1997:399-411.
56.
Zigmond AS, Snaith RP: The hospital anxiety and depression scale. Acta Psychiatr Scand 1983, 67: 361-370.CrossRefPubMed
57.
Brandt J, Welsh KA, Breitner JC, Folstein MF, Helms M, Christian JC: Hereditary influences on cognitive functioning in older men. A study of 4000 twin pairs. Arch Neurol 1993, 50: 599-603.CrossRefPubMed
58.
Baker JP, Detsky AS, Wesson DE, Wolman SL, Stewart S, Whitewell J, Langer B, Jeejeebhoy KN: Nutritional assessment: a comparison of clinical judgement and objective measurements. N Engl J Med 1982, 306: 969-972.CrossRefPubMed
Metadata
Title
Study protocol: The Improving Care of Acute Lung Injury Patients (ICAP) study
Authors
Dale M Needham
Cheryl R Dennison
David W Dowdy
Pedro A Mendez-Tellez
Nancy Ciesla
Sanjay V Desai
Jonathan Sevransky
Carl Shanholtz
Daniel Scharfstein
Margaret S Herridge
Peter J Pronovost
Publication date
01-02-2005
Publisher
BioMed Central
Published in
Critical Care / Issue 1/2006
Electronic ISSN: 1364-8535
DOI
https://doi.org/10.1186/cc3948

Other articles of this Issue 1/2006

Critical Care 1/2006 Go to the issue

Review

Direct patient care during an acute disaster: chasing the will-o'-the-wisp

Commentary

Survival methods, including those using competing risk analysis, are not appropriate for intensive care unit outcome studies

Review

Clinical review: Percutaneous dilatational tracheostomy

Commentary

Information technology issues during and after Katrina and usefulness of the Internet: how we mobilized and utilized digital communications systems

Research

Levosimendan may improve survival in patients requiring mechanical assist devices for post-cardiotomy heart failure

Research

Rescue treatment with terlipressin in children with refractory septic shock: a clinical study