Respiratory Distress Syndrome, Adult Clinical Trial
Official title:
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.
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.
;
Observational Model: Cohort, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03712215 -
STUDY OF ELECTRICAL STIMULATION IN PULMONARY FUNCTION IN INTENSIVE CARE UNIT
|
N/A | |
Completed |
NCT04582201 -
Evaluate the Safety of agenT-797 in Participants With Moderate to Severe Difficulty Breathing Secondary to SARS-CoV-2
|
Phase 1/Phase 2 | |
Recruiting |
NCT01990456 -
Strategies for Optimal Lung Ventilation in ECMO for ARDS: The SOLVE ARDS Study
|
N/A | |
Completed |
NCT01167621 -
Changes in Refractory Acute Respiratory Distress Syndrome (ARDS) Patients Under High Frequency Oscillation-ventilation
|
N/A | |
Terminated |
NCT00233207 -
IC14 Antibodies to Treat Individuals With Acute Lung Injury
|
Phase 2 | |
Completed |
NCT00029328 -
Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation
|
Phase 1/Phase 2 | |
Completed |
NCT00004494 -
Phase I Study of Vasoactive Intestinal Peptide in Patients With Acute Respiratory Distress Syndrome and Sepsis
|
Phase 1 | |
Completed |
NCT00000579 -
Acute Respiratory Distress Syndrome Clinical Network (ARDSNet)
|
Phase 3 | |
Recruiting |
NCT03236272 -
Establishment of a Biomarkers-based Early Warning System of Acute Respiratory Distress Syndrome (ARDS)
|
||
Withdrawn |
NCT04508933 -
Comparison of Extra Vascular Lung Water Index in Covid-19 ARDS and "Typical"ARDS Patients
|
||
Completed |
NCT02273687 -
Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in Emergency Department
|
N/A | |
Recruiting |
NCT03424798 -
Measuring Heart and Lung Function in Critical Care
|
N/A | |
Recruiting |
NCT01992237 -
Measuring Energy Expenditure in ECMO (Extracorporeal Membrane Oxygenation) Patients
|
N/A | |
Completed |
NCT00719446 -
Evaluating Health Outcomes and QOL After ALI Among Participants of the ALTA, OMEGA, EDEN, and SAILS ARDS Network Trials
|
N/A | |
Completed |
NCT00236262 -
Effect of Positive Expiratory Pressure on Right Ventricular Function in Patients With Respiratory Distress Syndrome
|
N/A | |
Completed |
NCT00157144 -
Australia and New Zealand Adult Extracorporeal Membrane Oxygenation (ECMO) Audit 2005
|
N/A | |
Completed |
NCT00141726 -
Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant
|
Phase 2 | |
Recruiting |
NCT00465374 -
A Validation/Interventional Study on Stress Index in Predicting Mechanical Stress in ARDS Patients
|
Phase 3 | |
Completed |
NCT00094406 -
Carbon Monoxide to Prevent Lung Inflammation
|
Phase 1 | |
Recruiting |
NCT03709199 -
Long Term Follow up of Children Enrolled in the REDvent Study
|