Respiratory Distress Syndrome, Adult Clinical Trial
Official title:
The Improving Care of Acute Lung Injury Patients (ICAP) Study
Verified date | August 2015 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Observational |
Acute lung injury/acute respiratory distress syndrome (ALI/ARDS) is a severe lung condition that causes respiratory failure. Individuals with ALI/ARDS often require the use of a respirator or artificial breathing machine, known as a mechanical ventilator, while in an intensive care unit (ICU). Past research has shown that improved short-term clinical outcomes result from the use of a protective mechanical ventilation technique for the lungs. This study will evaluate the effects of lower tidal volume ventilation, and other aspects of critical illness and ICU care, on the long-term clinical outcomes of individuals with ALI/ARDS.
Status | Completed |
Enrollment | 520 |
Est. completion date | October 2012 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Residing in the ICU - Receiving mechanical ventilation - Meets criteria for the diagnosis of ALI/ARDS, as defined by the American-European Consensus Conference Exclusion Criteria: - Received diagnosis of ALI/ARDS more than 96 hours prior to study entry - Received more than five days of mechanical ventilation during the present hospitalization prior to study entry - Pre-existing ALI/ARDS for more than 24 hours when transferred to the study ICU - Pre-existing illness with a life expectancy of less than six months - Any limitations in ICU care at study entry (e.g., no vasopressor) - Previous lung resection - Inability to speak or understand English - No fixed address |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Bayview Medical Center | Baltimore | Maryland |
United States | Johns Hopkins Hospital | Baltimore | Maryland |
United States | University of Maryland Medical Center | Baltimore | Maryland |
United States | Veterans Affairs Hospital | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Ciesla N, Barbe C, Patel N, Mendez-Tellez PA, Dennison CR, Needham DM. Physical therapy for the intensive care unit: implications based on evaluation of critical care management of 150 acute lung injury/acute respiratory distress syndrome patients. Cardiopulmonary Physical Therapy Journal 17(4): 142, 2006.
Dennison CR, Mendez-Tellez PA, Wang W, Pronovost PJ, Needham DM. Barriers to low tidal volume ventilation in acute respiratory distress syndrome: survey development, validation, and results. Crit Care Med. 2007 Dec;35(12):2747-54. — View Citation
Desai SV, Boucher K, Fan E, Needham DM. Long-term outcomes after acute lung injury. Contemporary Critical Care. 2006;4:1-10
Dowdy DW, Bienvenu OJ, Dinglas VD, Mendez-Tellez PA, Sevransky J, Shanholtz C, Needham DM. Are intensive care factors associated with depressive symptoms 6 months after acute lung injury? Crit Care Med. 2009 May;37(5):1702-7. doi: 10.1097/CCM.0b013e31819f — View Citation
Dowdy DW, Dinglas V, Mendez-Tellez PA, Bienvenu OJ, Sevransky J, Dennison CR, Shanholtz C, Needham DM. Intensive care unit hypoglycemia predicts depression during early recovery from acute lung injury. Crit Care Med. 2008 Oct;36(10):2726-33. doi: 10.1097/CCM.0b013e31818781f5. — View Citation
Dowdy DW, Eid MP, Dennison CR, Mendez-Tellez PA, Herridge MS, Guallar E, Pronovost PJ, Needham DM. Quality of life after acute respiratory distress syndrome: a meta-analysis. Intensive Care Med. 2006 Aug;32(8):1115-24. Epub 2006 Jun 17. — View Citation
Dowdy DW, Eid MP, Sedrakyan A, Mendez-Tellez PA, Pronovost PJ, Herridge MS, Needham DM. Quality of life in adult survivors of critical illness: a systematic review of the literature. Intensive Care Med. 2005 May;31(5):611-20. Epub 2005 Apr 1. Review. Erratum in: Intensive Care Med. 2005 Jul;31(7):1007. — View Citation
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 Jul;31(7):914-21. Epub 2005 May 21. Review. Erratum in: Intensive Care Med. 2005 Sep;31(9):1299. — View Citation
Fan E, Khatri P, Mendez-Tellez PA, Shanholtz C, Needham DM. Review of a large clinical series: sedation and analgesia usage with airway pressure release and assist-control ventilation for acute lung injury. J Intensive Care Med. 2008 Nov-Dec;23(6):376-83. doi: 10.1177/0885066608324293. Epub 2008 Sep 19. — View Citation
Fan E, Needham DM, Stewart TE. Ventilatory management of acute lung injury and acute respiratory distress syndrome. JAMA. 2005 Dec 14;294(22):2889-96. Review. — View Citation
Fan E, Shahid S, Kondreddi VP, Bienvenu OJ, Mendez-Tellez PA, Pronovost PJ, Needham DM. Informed consent in the critically ill: a two-step approach incorporating delirium screening. Crit Care Med. 2008 Jan;36(1):94-9. — View Citation
Murphy DJ, Howard D, Muriithi A, Mendez-Tellez P, Sevransky J, Shanholtz C, Netzer G, Pronovost PJ, Needham DM. Red blood cell transfusion practices in acute lung injury: what do patient factors contribute? Crit Care Med. 2009 Jun;37(6):1935-40. doi: 10.1 — View Citation
Needham DM, Dennison CR, Dowdy DW, Mendez-Tellez PA, Ciesla N, Desai SV, Sevransky J, Shanholtz C, Scharfstein D, Herridge MS, Pronovost PJ. Study protocol: The Improving Care of Acute Lung Injury Patients (ICAP) study. Crit Care. 2006 Feb;10(1):R9. — View Citation
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 Sep;31(9):1153-60. Epub 2005 May 21. Review. — View Citation
Needham DM, Pronovost PJ. Affordable health care. Critical Care Medicine. 2004; 32:2564
Needham DM, Wang W, Desai SV, Mendez-Tellez PA, Dennison CR, Sevransky J, Shanholtz C, Ciesla N, Spillman K, Pronovost PJ. Intensive care unit exposures for long-term outcomes research: development and description of exposures for 150 patients with acute lung injury. J Crit Care. 2007 Dec;22(4):275-84. Epub 2007 Jun 27. — View Citation
Sevransky JE, Martin GS, Mendez-Tellez P, Shanholtz C, Brower R, Pronovost PJ, Needham DM. Pulmonary vs nonpulmonary sepsis and mortality in acute lung injury. Chest. 2008 Sep;134(3):534-8. doi: 10.1378/chest.08-0309. Epub 2008 Jul 18. — View Citation
Umoh NJ, Fan E, Mendez-Tellez PA, Sevransky JE, Dennison CR, Shanholtz C, Pronovost PJ, Needham DM. Patient and intensive care unit organizational factors associated with low tidal volume ventilation in acute lung injury. Crit Care Med. 2008 May;36(5):1463-8. doi: 10.1097/CCM.0b013e31816fc3d0. — View Citation
* Note: There are 18 references in all — Click here to view all references
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