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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

Tracking Information
First Submitted Date  ICMJE May 22, 2020
First Posted Date  ICMJE May 27, 2020
Last Update Posted Date November 3, 2020
Actual Study Start Date  ICMJE April 24, 2020
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2020)
  • Adverse events related to SGB [ Time Frame: 3 Months ]
    Adverse events that can atleast unlikely be attributed to SGB
  • All Adverse events [ Time Frame: 3 Months ]
    All adverse events related to COVID-19
  • Death [ Time Frame: 3 Months ]
    Death due to any cause
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2020)
  • Assessment of respiratory/ pulmonary function [ Time Frame: 3 Months ]
    Change from baseline clinical respiratory/pulmonary function as assessed by change in PF ratio
  • Radiographic criteria [ Time Frame: 3 Months ]
    Change from last imaging data obtained prior to SGB procedure
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2020)
  • PaO2/FiO2 or SpO2/FiO2(SF) ratio change from baseline [ Time Frame: 3 Months ]
    Change from baseline (descibed as last ratio prior to procedure)
  • Radiographic criteria [ Time Frame: 3 Months ]
    Change from last imaging data obtained prior to SGB procedure
  • Incidence of cardiac arrhythmia [ Time Frame: 3 Months ]
  • Resolution of cardiac arrhythmia [ Time Frame: 3 Months ]
  • Cardiac function [ Time Frame: 3 Months ]
  • Clinical relevant Laboratory testing (d-dimer, Ferritin, Troponin T, LDH) [ Time Frame: 3 Months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stellate Ganglion Block (SGB) for COVID-19 Acute Respiratory Distress Syndrome (ARDS)
Official Title  ICMJE Stellate Ganglion Block (SGB) for COVID-19 Acute Respiratory Distress Syndrome (ARDS)
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Respiratory Distress Syndrome
  • COVID-19
Intervention  ICMJE Procedure: Stellate Ganglion Block
The procedure will be done at the bedside in the ICU without interfering with ongoing treatment.
Study Arms  ICMJE Experimental: Stellate Ganglion Block (SGB)
Clinical Stellate ganglion block
Intervention: Procedure: Stellate Ganglion Block
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 22, 2020)
5
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Padma Tirumalai, PhD 3042934999 ptirumalai@hsc.wvu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04402840
Other Study ID Numbers  ICMJE 2004963113
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ali Rezai, West Virginia University
Study Sponsor  ICMJE West Virginia University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ali R Rezai, MD West Virginia University
PRS Account West Virginia University
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP