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

Not Applicable

Completed

• Conditions: Acute Respiratory Distress Syndrome; COVID-19
• Interventions: Procedure: Stellate Ganglion Block

• Registration Number: NCT04402840
• Lead Sponsor: West Virginia University

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

Study Timeline

• Study Start: 2020-04-24
• Study First Submitted: 2020-05-22
• Study First Submitted QC: 2020-05-22
• Study First Posted: 2020-05-27
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stellate Ganglion Block (SGB)	Stellate Ganglion Block	Clinical Stellate ganglion block

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

West Virginia University Rockefeller Neuroscience Institute; 🇺🇸 Morgantown, West Virginia, United States