Back to resultsStellate Ganglion Block (SGB) for COVID-19 Acute Respiratory Distress Syndrome (ARDS)
Primary Purpose
Acute Respiratory Distress Syndrome, COVID-19
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stellate Ganglion Block
Sponsored by
About this trial
This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring Acute Respiratory Distress Syndrome, COVID-19, Autonomic Nervous System, Stellate Ganglion
Eligibility Criteria
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
Sites / Locations
- West Virginia University Rockefeller Neuroscience Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stellate Ganglion Block (SGB)
Arm Description
Clinical Stellate ganglion block
Outcomes
Primary Outcome Measures
Adverse events related to SGB
Adverse events that can atleast unlikely be attributed to SGB
All Adverse events
All adverse events related to COVID-19
Death
Death due to any cause
Secondary Outcome Measures
Assessment of respiratory/ pulmonary function
Change from baseline clinical respiratory/pulmonary function as assessed by change in PF ratio
Radiographic criteria
Change from last imaging data obtained prior to SGB procedure
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04402840
Brief Title
Stellate Ganglion Block (SGB) for COVID-19 Acute Respiratory Distress Syndrome (ARDS)
Official Title
Stellate Ganglion Block (SGB) for COVID-19 Acute Respiratory Distress Syndrome (ARDS)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 24, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Virginia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome, COVID-19
Keywords
Acute Respiratory Distress Syndrome, COVID-19, Autonomic Nervous System, Stellate Ganglion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stellate Ganglion Block (SGB)
Arm Type
Experimental
Arm Description
Clinical Stellate ganglion block
Intervention Type
Procedure
Intervention Name(s)
Stellate Ganglion Block
Intervention Description
The procedure will be done at the bedside in the ICU without interfering with ongoing treatment.
Primary Outcome Measure Information:
Title
Adverse events related to SGB
Description
Adverse events that can atleast unlikely be attributed to SGB
Time Frame
3 Months
Title
All Adverse events
Description
All adverse events related to COVID-19
Time Frame
3 Months
Title
Death
Description
Death due to any cause
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Assessment of respiratory/ pulmonary function
Description
Change from baseline clinical respiratory/pulmonary function as assessed by change in PF ratio
Time Frame
3 Months
Title
Radiographic criteria
Description
Change from last imaging data obtained prior to SGB procedure
Time Frame
3 Months
Title
Cardiac function
Description
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)
Time Frame
3 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali R Rezai, MD
Organizational Affiliation
West Virginia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Virginia University Rockefeller Neuroscience Institute
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Stellate Ganglion Block (SGB) for COVID-19 Acute Respiratory Distress Syndrome (ARDS)
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