Severe ARDS: Generating Evidence

Study Overview
=================
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.

Official Title
-----------------
Severe ARDS: Generating Evidence. A U.S. Multicenter Observational Study.

Conditions
-----------------
Acute Respiratory Distress Syndrome, Acute Respiratory Failure With Hypoxia, Acute Respiratory Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Patients with acute respiratory failure requiring invasive mechanical ventilation via an endotracheal tube or tracheostomy with current or planned admission to the ICU Moderate-severe ARDS as defined by fulfillment of all of the following within 48 hours: Bilateral opacities detected on chest radiograph or CT, not fully explained by effusions, lung collapse, or nodules Respiratory failure not fully explained by cardiac failure or fluid overload PaO2/FiO2 ratio < 150 with a minimum of 5 cmH20 PEEP Exclusion Criteria: There are no exclusion criteria.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Moderate-Severe ARDS<br>All adults admitted to participating ICUs with study-defined moderate-to-severe ARDS. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Mortality |  | 28 Days | 
| Use of Adjunctive Therapy |  | 28 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator-Free Days |  | 28 Days | 
| ICU-Free Days |  | 28 Days | 
| Organ Failure |  | 7 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ALI, ECMO, Acute Respiratory Distress Syndrome, ARDS, Acute Lung Injury, Mechanical Ventilation, Extracorporeal Membrane Oxygenation, Neuromuscular Blockade, Vasodilator Agents, Prone Position, Acute Respiratory Failure