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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00300248
Recruitment Status : Completed
First Posted : March 8, 2006
Last Update Posted : September 1, 2015
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Dale Needham, Johns Hopkins University

Tracking Information
First Submitted Date March 7, 2006
First Posted Date March 8, 2006
Last Update Posted Date September 1, 2015
Study Start Date October 2004
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 14, 2013)
Mortality [ Time Frame: Measured at Months 3, 6, 12, 24, 36, 48 and 60 ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Long-Term Results in Mechanically Ventilated Individuals With Acute Lung Injury/Acute Respiratory Distress Syndrome
Official Title The Improving Care of Acute Lung Injury Patients (ICAP) Study
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 13 critical care units at 4 academic hospitals in Baltimore, MD
Condition Respiratory Distress Syndrome, Adult
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 7, 2006)
520
Original Enrollment Same as current
Actual Study Completion Date October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00300248
Other Study ID Numbers 1329
P50HL073994-03 ( U.S. NIH Grant/Contract )
R01HL088045 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dale Needham, Johns Hopkins University
Study Sponsor Johns Hopkins University
Collaborators National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Peter J. Pronovost, MD, PhD Johns Hopkins University
Principal Investigator: Dale M. Needham, MD, PhD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date August 2015