Clinical trial NCT04445337: Stellate Ganglion Blockade in Corona Virus 2019 (COVID-19) Positive Patients
Official title: Stellate Ganglion Blockade in COVID-19 Positive Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: COVID 19
ARDS
Keywords: stellate ganglion
perineural block
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2020-06-24
Enrollment: 1
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-label use of stellate ganglion block.
Primary purpose: PREVENTION

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 (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 sodium phosphate (PF) 5mg, and 0.25% bupivacaine 5 ml is delivered. An ONQ brand 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.

Eligibility criteria: Inclusion Criteria:

* 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 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/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).

Primary outcomes:
measure: Evaluate the Safety of a New Modified Stellate Ganglia Block (SGB) in Acute Respiratory Distress Syndrome (ARDS)
timeFrame: 3 month
Secondary outcomes:
measure: Evaluating Stellate Ganglion Block Adverse Events.
timeFrame: 3 month
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Michael Lankhorst, MD
role: PRINCIPAL_INVESTIGATOR
References: