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Completed

NCT Number: NCT04402840

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

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.

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Key information

Conditions

Acute Respiratory Distress Syndrome COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West Virginia University Rockefeller Neuroscience Institute

Morgantown, West Virginia, 26506, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stellate ganglion block

Procedure

The procedure will be done at the bedside in the ICU without interfering with ongoing treatment.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

West Virginia University

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 27, 2020
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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