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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2020

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

- To determine efficacy of SGB in improving recovery of lung function in ARDS

- To determine efficacy of SGB in cardiac function and reducing arrhythmias associated with ARDS

- To determine efficacy of SGB in reducing the utilization of ECMO for ARDS

- To assess the duration of SGB on sympathetic tone

Hypothesis:

Stellate ganglion (SG) is an important anatomical sympathetic gateway/node to the heart and lung with afferent and efferent inputs. ARDS is associated with a hyper sympathetic response with local activation and priming of the SG and input to the brain and output to the heart and the lung.

SGB block is safe. It will block the pulmonary afferents through the SG to Dorsal root ganglia (DRG) to spinal cord and to brain, that initiate the hypersympathetic response and neurohumoral cascade of exaggerated inflammatory response and will block the sympathetic efferent. It will also stop or reduce the cardiac arrhythmias that accompany the increased cardio-pulmonary sympathetic over activity

Interventions

  • Procedure: Stellate Ganglion Block
    • Bilateral stellate ganglion block (staged or simultaneous) with or without the use of imaging guidance. The procedure will be done at the bedside in the ICU without interfering with ongoing treatment.

Arms, Groups and Cohorts

  • Experimental: Stellate Ganglion Block (SGB)
    • 5-10 milliliters of a local anesthetic such as lidocaine 1-2% or 0.25% bupivacaine with 4mg Dexamethasone is injected

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • PaO2/FiO2 or SpO2/FiO2(SF) ratio change from baseline
    • Time Frame: 3 Months
    • Change from baseline (descibed as last ratio prior to procedure)
  • Radiographic criteria
    • Time Frame: 3 Months
    • change from last imaging data obtained prior to SGB procedure
  • Incidence of cardiac arrhythmia
    • Time Frame: 3 Months
  • Resolution of cardiac arrhythmia
    • Time Frame: 3 Months
  • Cardiac function
    • Time Frame: 3 Months
  • Clinical relevant Laboratory testing (d-dimer, Ferritin, Troponin T, LDH)
    • Time Frame: 3 Months

Participating in This Clinical Trial

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 (prehospitalization) diagnosis of cardiac failure or fluid overload
  • Hemodynamic Instability (> 2 vasopressors)
  • Subject on Extracorporeal membrane oxygenation (ECMO)
  • Anatomical inability to do a stellate block
  • Uncorrectable coagulopathy
  • Previous sympathectomy
  • Subject with multi-organ failure-MOF ( more than 2 organs)
  • Subject on Tocilizumab anti-IL-6 MAB trial with a clinical response within 48 hours
  • Subject on Nitric Oxide treatment with a clinical response within 48 hours

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • West Virginia University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ali Rezai, Director – West Virginia University
  • Overall Official(s)
    • Ali R Rezai, MD, Principal Investigator, West Virginia University
  • Overall Contact(s)
    • Padma Tirumalai, PhD, 3042934999, ptirumalai@hsc.wvu.edu

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