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

• Sponsor: West Virginia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04402840
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arm: 1
• Actual Duration (Months): 8.2
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Distress Syndrome; COVID-19	Procedure: Stellate Ganglion Block	N/A

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Stellate Ganglion Block (SGB) for COVID-19 Acute Respiratory Distress Syndrome (ARDS)
• Actual Study Start Date: Apr 24, 2020
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stellate Ganglion Block (SGB) Clinical Stellate ganglion block	Procedure: Stellate Ganglion Block; The procedure will be done at the bedside in the ICU without interfering with ongoing treatment.

Outcome Measures

Primary Outcome Measures

1. Adverse events related to SGB [3 Months]

   Adverse events that can atleast unlikely be attributed to SGB

2. All Adverse events [3 Months]

   All adverse events related to COVID-19

3. Death [3 Months]

   Death due to any cause

Secondary Outcome Measures

1. Assessment of respiratory/ pulmonary function [3 Months]

   Change from baseline clinical respiratory/pulmonary function as assessed by change in PF ratio

2. Radiographic criteria [3 Months]

   Change from last imaging data obtained prior to SGB procedure

3. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West Virginia University Rockefeller Neuroscience Institute	Morgantown	West Virginia	United States	26506

Sponsors and Collaborators

• West Virginia University

Investigators

• Principal Investigator: Ali R Rezai, MD, West Virginia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ali Rezai, Director, West Virginia University
• ClinicalTrials.gov Identifier: NCT04402840
• Other Study ID Numbers: 2004963113
• First Posted: May 27, 2020
• Last Update Posted: Jul 20, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ali Rezai, Director, West Virginia University: Acute Respiratory Distress Syndrome; COVID-19; Autonomic Nervous System; Stellate Ganglion
• Additional relevant MeSH terms: COVID-19; Ganglion Cysts; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome

Study Results

No Results Posted as of Jul 20, 2022