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

July 19, 2022 updated by: Ali Rezai, West Virginia University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Rockefeller Neuroscience Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of respiratory/ pulmonary function
Time Frame: 3 Months
Change from baseline clinical respiratory/pulmonary function as assessed by change in PF ratio
3 Months
Radiographic criteria
Time Frame: 3 Months
Change from last imaging data obtained prior to SGB procedure
3 Months
Cardiac function
Time Frame: 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)
3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West Virginia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 24, 2020

Primary Completion (ACTUAL)

December 31, 2020

Study Completion (ACTUAL)

December 31, 2020

Study Registration Dates

First Submitted

May 22, 2020

First Submitted That Met QC Criteria

May 22, 2020

First Posted (ACTUAL)

May 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004963113

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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