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

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.

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