Status:
TERMINATED
Stellate Ganglion Blockade in Corona Virus 2019 (COVID-19) Positive Patients
Lead Sponsor:
University of Nebraska
Conditions:
COVID 19
ARDS
Eligibility:
All Genders
19-85 years
Phase:
PHASE1
Brief Summary
This study will establish the safety and efficacy of using stellate ganglion blocks in patients with acute respiratory distress syndrome (ARDS) due to COVID-19 disease.
Detailed Description
The stellate ganglion block (SGB) will be performed in the ICU. Nurse will provide patient monitoring and assistance during the procedure. Standard monitors and advanced cardiovascular life support (A...
Eligibility Criteria
Inclusion
- Any patient between the ages of 19-85 with laboratory established COVID-19 infection via Real-Time Reverse Transcription-Polymerase Chain Reaction (rRT-PCR) requiring critical care in an intensive care unit.
- Signs or symptoms consistent with ARDS must be present.
- The syndrome must present acutely, ratio of arterial oxygen partial pressure to fractional inspired oxygen (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
- 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/acute respiratory distress syndrome (ARDS)
- uncorrectable coagulopathy, already on Extracorporeal membrane oxygenation (ECMO), already on Nitric Oxide, pre-existing multi-organ failure (\>2 organ systems).
Key Trial Info
Start Date :
November 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2021
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04445337
Start Date
November 15 2020
End Date
November 1 2021
Last Update
January 20 2025
Active Locations (1)
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1
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198