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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04402840
Recruitment Status : Recruiting
First Posted : May 27, 2020
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
Ali Rezai, West Virginia University

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 24, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Adverse events related to SGB [ Time Frame: 3 Months ]
    Adverse events that can atleast unlikely be attributed to SGB

  2. All Adverse events [ Time Frame: 3 Months ]
    All adverse events related to COVID-19

  3. Death [ Time Frame: 3 Months ]
    Death due to any cause


Secondary Outcome Measures :
  1. Assessment of respiratory/ pulmonary function [ Time Frame: 3 Months ]
    Change from baseline clinical respiratory/pulmonary function as assessed by change in PF ratio

  2. Radiographic criteria [ Time Frame: 3 Months ]
    Change from last imaging data obtained prior to SGB procedure

  3. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04402840


Contacts
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Contact: Padma Tirumalai, PhD 3042934999 ptirumalai@hsc.wvu.edu

Locations
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United States, West Virginia
West Virginia University Rockefeller Neuroscience Institute Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Padma Tirumalai, PhD    304-293-4999    ptirumalai@hsc.wvu.edu   
Principal Investigator: Ali Rezai         
Sponsors and Collaborators
West Virginia University
Investigators
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Principal Investigator: Ali R Rezai, MD West Virginia University
More Information
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Responsible Party: Ali Rezai, Director, West Virginia University
ClinicalTrials.gov Identifier: NCT04402840    
Other Study ID Numbers: 2004963113
First Posted: May 27, 2020    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ali Rezai, West Virginia University:
Acute Respiratory Distress Syndrome
COVID-19
Autonomic Nervous System
Stellate Ganglion
Additional relevant MeSH terms:
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Ganglion Cysts
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
 Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases