Back to resultsStellate Ganglion Blockade in COVID-19 Positive Patients
Primary Purpose
COVID 19, ARDS
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 COVID 19 focused on measuring stellate ganglion, perineural block
Eligibility Criteria
Inclusion Criteria:
- Any patient between the ages of 19-85 with laboratory established COVID-19 infection (via rRT-PCR) requiring critical care in an intensive care unit.
- Signs or symptoms consistent with ARDS must be present.
- The syndrome must present acutely, PaO2/FIO2 ≤ 200 mm Hg, bilateral infiltrates on chest radiograph or CT not due to cardiac failure, need for non-invasive or invasive mechanical ventilation, and any cardiac dysrhythmia (excluding sinus tachycardia).
Exclusion Criteria:
- Hemodynamic instability (>2 vasopressors)
- pre-hospital diagnosis of heart failure or fluid overload
- anatomical inability to perform block
- prior sympathectomy
- patient currently enrolled in another clinical trial for COVID-19 or respiratory distress/ARDS
- uncorrectable coagulopathy, already on ECMO, already on Nitric Oxide, pre-existing multi-organ failure (>2 organ systems).
Sites / Locations
- University of Nebraska Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Open Label SGB
Arm Description
Initial perineural bolus injection - clonidine 100 mcg, Decadron PF 5mg, and 0.25% bupivacaine 5 ml will be used for SGB block.
Outcomes
Primary Outcome Measures
Evaluate the safety of a new modified stellate ganglia block (SGB) in ARDS
Adverse events related to SGB.
Secondary Outcome Measures
Evaluate the efficacy of a new modified stellate ganglia block (SGB) in ARDS
All adverse events.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04445337
Brief Title
Stellate Ganglion Blockade in COVID-19 Positive Patients
Official Title
Stellate Ganglion Blockade in COVID-19 Positive Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 15, 2020 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
November 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nebraska
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will establish the safety and efficacy of using stellate ganglion blocks in patients with ARDS due to COVID-19 disease.
Detailed Description
The attending proceduralist will perform the SGB in the ICU. Nurse will provide patient monitoring and assistance during the procedure. Standard monitors and ACLS resuscitative equipment will be immediately available. A norepinephrine solution will be at bedside to treat potential hypotension associated with SGB. The SGB perineural catheter will be placed using standard sterile technique. Initial perineural bolus injection - clonidine 100 mcg, Decadron PF 5mg, and 0.25% bupivacaine 5 ml is delivered. An OnQ perineural infusion 0.2% bupivacaine will be initiated at 2ml/hr for 5 days. Acute pain service will discontinue infusion and remove the catheter after 5 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID 19, ARDS
Keywords
stellate ganglion, perineural block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Open-label use of stellate ganglion block.
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open Label SGB
Arm Type
Experimental
Arm Description
Initial perineural bolus injection - clonidine 100 mcg, Decadron PF 5mg, and 0.25% bupivacaine 5 ml will be used for SGB block.
Intervention Type
Procedure
Intervention Name(s)
Stellate Ganglion Block
Intervention Description
An injection of local anesthetic into the front of the neck. Medication used for the block include- clonidine 100 mcg, Decadron PF 5mg, and 0.25% bupivacaine 5 ml is delivered.
Primary Outcome Measure Information:
Title
Evaluate the safety of a new modified stellate ganglia block (SGB) in ARDS
Description
Adverse events related to SGB.
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Evaluate the efficacy of a new modified stellate ganglia block (SGB) in ARDS
Description
All adverse events.
Time Frame
3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any patient between the ages of 19-85 with laboratory established COVID-19 infection (via rRT-PCR) requiring critical care in an intensive care unit.
Signs or symptoms consistent with ARDS must be present.
The syndrome must present acutely, PaO2/FIO2 ≤ 200 mm Hg, bilateral infiltrates on chest radiograph or CT not due to cardiac failure, need for non-invasive or invasive mechanical ventilation, and any cardiac dysrhythmia (excluding sinus tachycardia).
Exclusion Criteria:
Hemodynamic instability (>2 vasopressors)
pre-hospital diagnosis of heart failure or fluid overload
anatomical inability to perform block
prior sympathectomy
patient currently enrolled in another clinical trial for COVID-19 or respiratory distress/ARDS
uncorrectable coagulopathy, already on ECMO, already on Nitric Oxide, pre-existing multi-organ failure (>2 organ systems).
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Stellate Ganglion Blockade in COVID-19 Positive Patients
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