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

NCT ID: NCT00300248

Last Updated: 2015-09-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 520 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2012-10-31

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.

Detailed Description

ALI/ARDS is a life-threatening condition that involves inflammation of the lungs and fluid accumulation in the air sacs, which leads to low blood oxygen levels and respiratory failure. Common causes include pneumonia, septic shock, and lung trauma. Symptoms usually develop within 24 to 48 hours of the original injury or illness, and most patients require immediate care in an intensive care unit (ICU). The main form of treatment for ALI/ARDS is the delivery of oxygen and a continuous level of pressure to the damaged lungs through mechanical ventilation. Past research has shown that lower tidal volume ventilation (LTVV), a protective ventilator management technique in which lower volumes of oxygen are administered, improves short-term clinical outcomes in individuals with ALI/ARDS. However, the long-term impact of LTVV remains unknown. The purpose of this study is to evaluate the effects of LTVV on long-term outcomes in individuals with ALI/ARDS.

This study will enroll individuals admitted to an ICU who have been recently diagnosed with ALI/ARDS. Once enrolled, participants' medical records will be reviewed for demographic and medical information. Participants will be examined to determine level of cognition and delirium. Questionnaires will be used to assess the participant's status prior to ICU admittance, including level of hearing, physical functioning, quality of life, employment, and living status. Questionnaires will be given to participants as well as a close contact to increase the reliability of feedback. While in the ICU, participants will receive normal clinical care. Data on laboratory tests, mechanical ventilator settings, arterial blood gas values, and medical status will be collected throughout the ICU stay. Information regarding the medical staff-to-patient ratio and the use of different medical treatments and therapies will also be collected by reviewing medical records and interviewing nurses. Follow-up evaluations, lasting approximately four hours each, will occur 3, 6, 12, 24, 36, 48 and 60 months following the ALI/ARDS diagnosis. At each follow-up visit, participants will undergo a physical examination, and standardized surveys and tests will be used to assess medical outcomes, organ impairment, pulmonary function, mental function, and quality of life. If participants are unable to return to the research clinic for the follow-up evaluations, visits may occur at their home or over the phone.

The original 2-year follow-up duration, for which participants were consented, was subsequently extended to allow 5-year follow-up. In recruiting these previously consented participants into the 5-year follow-up extension, they will be randomized to selected recruitment strategies (e.g., different mailing and telephone strategies) in order to gain insight regarding the most effective methods of recruiting participants.

Conditions

Respiratory Distress Syndrome, Adult

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Dale Needham

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter J. Pronovost, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Dale M. Needham, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

University of Maryland Medical Center

Baltimore, Maryland, United States

Veterans Affairs Hospital

Baltimore, Maryland, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Bayview Medical Center

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 16420652 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16352797 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15909169 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15909168 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15803303 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16783553 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 15599184 (View on PubMed)

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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 18086397 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17901838 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18090168 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18434907 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18766087 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18805857 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18641112 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19357507 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19384204 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28918401 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25478681 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22491953 (View on PubMed)

Other Identifiers

P50HL073994-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01HL088045

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1329

Identifier Type: -

Identifier Source: org_study_id