Acute Respiratory Distress Syndrome, COVID-19
Conditions
Keywords
Acute Respiratory Distress Syndrome, COVID-19, Autonomic Nervous System, Stellate Ganglion
Brief summary
The purpose of this study is to understand if it is safe and useful to perform SGB (Stellate Ganglion Block) in patients who have severe lung injury Acute Respiratory Distress Syndrome (ARDS) due to COVID-19 infection.
Detailed description
Primary Aim: • To determine safety of stellate ganglion block (SGB) in ARDS Secondary Aim: * To determine efficacy of SGB in slowing the progression of ARDS
Interventions
The procedure will be done at the bedside in the ICU without interfering with ongoing treatment.
Sponsors
Study design
Eligibility
Inclusion criteria
* Subjects age 18 to 80 * Subjects with PCR documented diagnosis of COVID-19 ARDS requiring critical care and transfer to intensive care unit * Bilateral opacities consistent with pulmonary edema must be present and may be detected on CT or chest radiograph
Exclusion criteria
* Subjects with pre-existing cardiac failure * Hemodynamic Instability * Subject on Extracorporeal membrane oxygenation (ECMO) * Anatomical inability to do a stellate block
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events related to SGB | 3 Months | Adverse events that can atleast unlikely be attributed to SGB |
| All Adverse events | 3 Months | All adverse events related to COVID-19 |
| Death | 3 Months | Death due to any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of respiratory/ pulmonary function | 3 Months | Change from baseline clinical respiratory/pulmonary function as assessed by change in PF ratio |
| Radiographic criteria | 3 Months | Change from last imaging data obtained prior to SGB procedure |
| Cardiac function | 3 Months | Change from baseline clinical cardiac function as assessed by improvement in arrhythmia as measured by standard of care ECG ( rate, rhythm and / or any aberrant electro physiological changes) |
Countries
United States