Severe ARDS: Generating Evidence
Purpose
An assessment of early management of moderate-severe ARDS in the United States, including ventilator management and use of rescue therapy.
Conditions
- Acute Respiratory Distress Syndrome
- Acute Respiratory Failure With Hypoxia
- Acute Respiratory Failure
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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 exclusion criteria.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Moderate-Severe ARDS | All adults admitted to participating ICUs with study-defined moderate-to-severe ARDS. |
More Details
- Status
- Completed
- Sponsor
- Montefiore Medical Center
Study Contact
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.