Brief Summary
An assessment of early management of moderate-severe ARDS in the United States, including ventilator management and use of rescue therapy.
Brief Title
Severe ARDS: Generating Evidence
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.
Completion Date
Completion Date Type
Actual
Conditions
Acute Respiratory Distress Syndrome
Acute Respiratory Failure With Hypoxia
Acute Respiratory Failure
Eligibility Criteria
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.
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.
Inclusion Criteria
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
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
Gender
All
Gender Based
false
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
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03021824
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2016-6757
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Severe ARDS: Generating Evidence. A U.S. Multicenter Observational Study.
Primary Outcomes
Outcome Measure
Hospital Mortality
Outcome Time Frame
28 Days
Outcome Measure
Use of Adjunctive Therapy
Outcome Time Frame
28 Days
Secondary Outcomes
Outcome Time Frame
28 Days
Outcome Measure
Ventilator-Free Days
Outcome Time Frame
28 Days
Outcome Measure
ICU-Free Days
Outcome Time Frame
7 Days
Outcome Measure
Organ Failure
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
All adults admitted to participating ICUs with study-defined moderate-to-severe ARDS.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jen-Ting Chen
Investigator Email
jeche@montefiore.org
Investigator Phone
646-229-2304
Categories Mesh Debug
Lung & Chest Cancers --- LUNG DISEASES
COVID-19 --- LUNG DISEASES
Lung --- LUNG DISEASES
Asthma and Other Respiratory Diseases --- RESPIRATORY TRACT DISEASES
Lung & Chest Cancers --- RESPIRATORY TRACT DISEASES
COVID-19 --- RESPIRATORY TRACT DISEASES
Lung --- RESPIRATORY TRACT DISEASES
MeSH Terms
RESPIRATORY DISTRESS SYNDROME
ACUTE LUNG INJURY
LUNG DISEASES
RESPIRATORY TRACT DISEASES
RESPIRATION DISORDERS
LUNG INJURY