Stellate Ganglion Block (SGB) for COVID-19 Acute Respiratory Distress Syndrome (ARDS)

Study Overview
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Brief Summary
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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
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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

Official Title
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Stellate Ganglion Block (SGB) for COVID-19 Acute Respiratory Distress Syndrome (ARDS)

Conditions
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Acute Respiratory Distress Syndrome, COVID-19

Intervention / Treatment
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* Procedure: Stellate Ganglion Block


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stellate Ganglion Block (SGB)<br>Clinical Stellate ganglion block | Procedure: Stellate Ganglion Block<br>* The procedure will be done at the bedside in the ICU without interfering with ongoing treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events related to SGB | Adverse events that can atleast unlikely be attributed to SGB | 3 Months | 
| All Adverse events | All adverse events related to COVID-19 | 3 Months | 
| Death | Death due to any cause | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of respiratory/ pulmonary function | Change from baseline clinical respiratory/pulmonary function as assessed by change in PF ratio | 3 Months | 
| Radiographic criteria | Change from last imaging data obtained prior to SGB procedure | 3 Months | 
| Cardiac function | 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) | 3 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Respiratory Distress Syndrome, COVID-19, Autonomic Nervous System, Stellate Ganglion