Acute Respiratory Distress Syndrome, Acute Respiratory Failure, Acute Respiratory Failure With Hypoxia
Conditions
Keywords
Acute Respiratory Distress Syndrome, ARDS, Acute Lung Injury, ALI, Mechanical Ventilation, Extracorporeal Membrane Oxygenation, Neuromuscular Blockade, Vasodilator Agents, Prone Position, ECMO, Acute Respiratory Failure
Brief summary
An assessment of early management of moderate-severe ARDS in the United States, including ventilator management and use of rescue therapy.
Detailed description
Approximately one-quarter of ARDS patients develop severe hypoxemia, which has been associated with mortality rates approximating 40-50%. The majority have been described to present with severe disease at baseline, suggesting an opportunity for early intervention. In addition, use of evidence-based practices in severe ARDS is highly variable and inconsistent; use of unproven treatment modalities is also frequently seen. Given the variability in treatment practices in severe ARDS, an understanding of the patient-level and institutional-level factors contributing to differences in therapeutic approach is needed in order to improve the quality and consistency of care given to these high-risk patients. SAGE is a multicenter, observational cohort study examining the patient-level and institutional characteristics associated with variability in management of patients with moderate to severe ARDS, factors associated with survival or need for adjuvant therapy, and variability in ventilator management of patients on extracorporeal membrane oxygenation. Findings from this observational study can subsequently be used to inform future interventional trial development.
Interventions
None listed
Sponsors
University of Michigan
Duke University
University of California, Los Angeles
Montefiore Medical Center
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \> 18 years 2. Patients with acute respiratory failure requiring invasive mechanical ventilation via an endotracheal tube or tracheostomy with current or planned admission to the ICU 3. Moderate-severe ARDS as defined by fulfillment of all of the following within 48 hours: 1. Bilateral opacities detected on chest radiograph or CT, not fully explained by effusions, lung collapse, or nodules 2. Respiratory failure not fully explained by cardiac failure or fluid overload 3. PaO2/FiO2 ratio \< 150 with a minimum of 5 cmH20 PEEP
Exclusion criteria
There are no
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hospital Mortality | 28 Days |
| Use of Adjunctive Therapy | 28 Days |
Secondary
| Measure | Time frame |
|---|---|
| Ventilator-Free Days | 28 Days |
| ICU-Free Days | 28 Days |
| Organ Failure | 7 Days |
Countries
United States
Outcome results
None listed