Severe ARDS: Generating Evidence (SAGE)

Montefiore Medicine Academic Health System

Status: Completed

Conditions: Acute Respiratory Distress Syndrome; Acute Respiratory Failure With Hypoxia; Acute Respiratory Failure

Study type: Observational

Funder types: Other

Identifiers

NCT03021824

2016-6757

Details and patient eligibility

About

An assessment of early management of moderate-severe ARDS in the United States, including ventilator management and use of rescue therapy.

Full 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.

Enrollment: 2,400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 exclusion criteria.

Trial design

2,400 participants in 1 patient group

Moderate-Severe ARDS

Description:

All adults admitted to participating ICUs with study-defined moderate-to-severe ARDS.