Long-Term Results in Mechanically Ventilated Individuals With Acute Lung Injury/Acute Respiratory Distress Syndrome

NCT00300248 | Completed

• 3 other identifiers: 1329P50HL073994-03R01HL088045
• Study Type: observational
• Target: 520
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Respiratory Distress Syndrome, Adult

Keywords

Acute Respiratory Distress Syndrome; Acute Lung Injury; Respiratory Failure; ARDS, Human

Outcome Measures

Primary Outcomes (1)

• Mortality

  Measured at Months 3, 6, 12, 24, 36, 48 and 60

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

13 critical care units at 4 academic hospitals in Baltimore, MD

You may qualify if:

• Residing in the ICU
• Receiving mechanical ventilation
• Meets criteria for the diagnosis of ALI/ARDS, as defined by the American-European Consensus Conference

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (4)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Veterans Affairs Hospital

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (21)

• 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. doi: 10.1186/cc3948.

  PMID: 16420652 BACKGROUND

• 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. doi: 10.1001/jama.294.22.2889.

  PMID: 16352797 BACKGROUND

• 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. doi: 10.1007/s00134-005-2656-7. Epub 2005 May 21.

  PMID: 15909169 BACKGROUND

• 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. doi: 10.1007/s00134-005-2657-6. Epub 2005 May 21.

  PMID: 15909168 BACKGROUND

• 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. doi: 10.1007/s00134-005-2592-6. Epub 2005 Apr 1.

  PMID: 15803303 BACKGROUND

• 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. doi: 10.1007/s00134-006-0217-3. Epub 2006 Jun 17.

  PMID: 16783553 BACKGROUND

• Desai SV, Boucher K, Fan E, Needham DM. Long-term outcomes after acute lung injury. Contemporary Critical Care. 2006;4:1-10

  BACKGROUND

• Moss RE. Affordable health care. Crit Care Med. 2004 Dec;32(12):2564; author reply 2564. doi: 10.1097/01.ccm.0000153900.88044.b5. No abstract available.

  PMID: 15599184 BACKGROUND

• 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.

  BACKGROUND

• 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. doi: 10.1016/j.jcrc.2007.02.001. Epub 2007 Jun 27.

  PMID: 18086397 BACKGROUND

• 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. doi: 10.1097/01.CCM.0000287591.09487.70.

  PMID: 17901838 BACKGROUND

• 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. doi: 10.1097/01.CCM.0000295308.29870.4F.

  PMID: 18090168 BACKGROUND

• 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.

  PMID: 18434907 BACKGROUND

• 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.

  PMID: 18766087 BACKGROUND

• 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.

  PMID: 18805857 BACKGROUND

• 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):534-538. doi: 10.1378/chest.08-0309. Epub 2008 Jul 18.

  PMID: 18641112 BACKGROUND

• 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.0b013e31819fea55.

  PMID: 19357507 RESULT

• 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: 10.1097/CCM.0b013e3181a0022d.

  PMID: 19384204 RESULT

• Kamdar BB, Sepulveda KA, Chong A, Lord RK, Dinglas VD, Mendez-Tellez PA, Shanholtz C, Colantuoni E, von Wachter TM, Pronovost PJ, Needham DM. Return to work and lost earnings after acute respiratory distress syndrome: a 5-year prospective, longitudinal study of long-term survivors. Thorax. 2018 Feb;73(2):125-133. doi: 10.1136/thoraxjnl-2017-210217. Epub 2017 Sep 16.

  PMID: 28918401 DERIVED

• Needham DM, Yang T, Dinglas VD, Mendez-Tellez PA, Shanholtz C, Sevransky JE, Brower RG, Pronovost PJ, Colantuoni E. Timing of low tidal volume ventilation and intensive care unit mortality in acute respiratory distress syndrome. A prospective cohort study. Am J Respir Crit Care Med. 2015 Jan 15;191(2):177-85. doi: 10.1164/rccm.201409-1598OC.

  PMID: 25478681 DERIVED

• Needham DM, Colantuoni E, Mendez-Tellez PA, Dinglas VD, Sevransky JE, Dennison Himmelfarb CR, Desai SV, Shanholtz C, Brower RG, Pronovost PJ. Lung protective mechanical ventilation and two year survival in patients with acute lung injury: prospective cohort study. BMJ. 2012 Apr 5;344:e2124. doi: 10.1136/bmj.e2124.

  PMID: 22491953 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Acute Lung Injury; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Injury

Study Officials

• Peter J. Pronovost, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Dale M. Needham, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 7, 2006
• First Posted: March 8, 2006
• Study Start: October 1, 2004
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: September 1, 2015

Record last verified: 2015-08

Locations

US (4)