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

August 31, 2015 updated by: Dale Needham, Johns Hopkins University

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

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

520

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins Hospital
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
      • Baltimore, Maryland, United States, 21224
        • Bayview Medical Center
      • Baltimore, Maryland, United States, 21201
        • Veterans Affairs Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: Measured at Months 3, 6, 12, 24, 36, 48 and 60
Measured at Months 3, 6, 12, 24, 36, 48 and 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Dale M. Needham, MD, PhD, Johns Hopkins University
  • Principal Investigator: Peter J. Pronovost, MD, PhD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

March 7, 2006

First Submitted That Met QC Criteria

March 7, 2006

First Posted (Estimate)

March 8, 2006

Study Record Updates

Last Update Posted (Estimate)

September 1, 2015

Last Update Submitted That Met QC Criteria

August 31, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1329
  • P50HL073994-03 (U.S. NIH Grant/Contract)
  • R01HL088045 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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