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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04402840
• Other study ID #: 2004963113
• Status: Completed
• Phase: N/A
• Start date: April 24, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2022
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• COVID-19
• Ganglion Cysts
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Procedure:
• Stellate Ganglion Block
The procedure will be done at the bedside in the ICU without interfering with ongoing treatment.

Locations

Country	Name	City	State
United States	West Virginia University Rockefeller Neuroscience Institute	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events related to SGB	Adverse events that can atleast unlikely be attributed to SGB	3 Months
Primary	All Adverse events	All adverse events related to COVID-19	3 Months
Primary	Death	Death due to any cause	3 Months
Secondary	Assessment of respiratory/ pulmonary function	Change from baseline clinical respiratory/pulmonary function as assessed by change in PF ratio	3 Months
Secondary	Radiographic criteria	Change from last imaging data obtained prior to SGB procedure	3 Months
Secondary	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