Clinical trial NCT03042663: Effect of Stellate Ganglion Block on Blood Flow in the Cannulated Radial Artery
Official title: Effect of Stellate Ganglion Block on Blood Flow in the Cannulated Radial Artery in Septic Shock Patients on Vasopressors, A Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stellate Ganglion Block
Radial Artery Cannulation
Keywords: stellate ganglion block
arterial cannula
ischemia
septic shock
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-02-03
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study will recruit septic shock patients with hemodynamic instability on vasopressor support and on direct arterial blood pressure monitoring through a radial arterial cannula that is not older than 12 hours.
Primary purpose: PREVENTION

Brief summary: To evaluate the value of US-guided Stellate ganglion block for improving radial arterial blood flow and peripheral perfusion in Septic shock patients on vasopressor support with an indwelling radial arterial cannula, which can result in reduced incidence premature failure of the catheter (due to vasospasm or thrombosis) and incidence of ischemic complications in the cannulated arm.

Detailed description: Radial artery cannulation is a well-established procedure in the ICU, especially in critically ill hemodynamically unstable patients. The first description of arterial cannulation in humans dates back to 1856, when the blood pressure was measured int the femoral artery. It can be used for continuous blood pressure monitoring, obtaining func¬tional hemodynamic parameters derived from the arterial waveform, to predict the physiologic response to fluid resuscitation and also for blood sampling.

The most common complications for the procedure are temporary radial artery occlusion (19.7%), in addition to hematoma (14.4%), infection at the arterial site (0.72%), hemorrhage (0.53%) or bacteremia (0.13%), pseudoaneurysm (0.09%) and finally ischemic damage (0.09%). Larger catheter diameter, presence of vasospasm, female sex (probably related to smaller vessel diameter) increase the risk of ischemic complications. Inadequate experience (high number of attempts, multiple arterial sticks and hematoma formation) can also increase the complication rate.

In a recent study by Numaguchi et al, they found that radial artery cannulation decreases the distal arterial blood flow measured by power Doppler ultrasound. In another study by Kim et al, they found that after radial artery cannulation ulnar artery diameters were significantly increased (compensatory) and radial artery diameters were decreased after cannulation compared with pre-cannulation values, then returned to pre-cannulation values 5 min after cannulation. They detected radial artery vasospasm in 12 patients with 20-G cannulas used (31.5%) and in 2 patients with 22-G cannulas used (5.3%) (p \< 0.05), which was observed immediately after cannulation, and had mostly disappeared after 5 min. There was no data regarding the follow up of the patients afterwards. In both studies the subjects were not critically ill patients (and not on vasopressors).

Peripheral limb ischemia in ICU patients can be the result of iatrogenic injury, thrombotic complications or hypoperfusion related to the underlying disease state. The patients at greatest risk for acute ischemia are those with underlying peripheral artery disease (PAD), but limb ischemia can also be the consequence of embolism, injury, dissection, or severe vasoconstriction, even in the absence of preexisting occlusive disease. Repeated arterial punctures may result in extensive hematoma formation and arterial spasm, The thick muscular coat and abundance of alpha adrenoreceptors make it prone to develop spasm when traumatized. Attempts to control bleeding following cannulation through local hemostasis only complicate matters. While, normally, the likelihood of serious ischemia is minimized by the presence of the palmar arterial arch.

The use of vasopressors especially nor-epinephrine with its potent α1-adrenergic receptor agonist activity can aggravate the condition more. We didn't find in the literature any reliable data regarding the effect of using vasopressors (particularly nor-epinephrine) in any dosage on the incidence of peripheral arterial vasospasm or ischemic complications following arterial cannulation. But there were mixed case reports linking both or one of them: high dose vasopressors and arterial cannulation, to ischemic complications. Such as developing peripheral gangrene after starting high dose vasopressors, or developing complex regional pain syndrome (CRPS) following radial artery cannulation.

It is believed that blocking the Stellate ganglion with Local anesthetics can interfere with the sympathetic out flow to the upper limb resulting in abolishing its vasoconstrictor action on the arteries thus decreasing arterial spasm and promoting better blood flow in the peripheral circulation.

Eligibility criteria: Inclusion Criteria:

* Age range of 18-80 years.
* Septic shock patients on vasopressor support (Nor-epinephrine or epinephrine).
* Presence of an indication for an arterial cannula.

Exclusion Criteria:

* Coagulopathies (with prothrombin concentration less than 60% or international normalized ratio INR more than 1.5)
* In-ability to postpone anti-coagulation medications.
* Infection or injury or a lesion at the block site.
* Suspected cervical vertebral column injury necessitating using a neck collar.
* Bradycardia with heart rate less than 60 beat per minute.
* A compromised lung on the contralateral side of the arterial cannula (Pneumothorax, hemothorax or Pneumonectomy).
* Recent cardiac insult (cardiogenic shock) (Due to blockage of the sympathetic cardiac accelerator fibers by the block).
* Traumatic vascular injuries or operative interventions (Surgical harvesting) involving arteries of the upper limb on either side.
* Peripheral vascular disease, atherosclerosis, atrial fibrillation, previous history of ischemic injuries, hypercoagulable syndromes.

Primary outcomes:
measure: change in Perfusion Index (PI)
timeFrame: After 30 minutes then every hour for 6 hours
Secondary outcomes:
measure: Perfusion Index (PI) after cannulation
timeFrame: 3 hours
measure: Perfusion Index (PI) after Stellate ganglion block
timeFrame: 6 hours
measure: Doppler Blood flow values after cannulation
timeFrame: 3 hours
measure: Doppler Blood flow after Stellate ganglion block
timeFrame: 6 hours
measure: Vasopressor drug dose
timeFrame: 6 hours
measure: Incidence of complications
timeFrame: 6 hours
measure: Incidence of ischemic complications
timeFrame: 6 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine, Cairo University teaching hospitals (Kasr Alainy)
Study officials:
References:
citation: Marik PE, Cavallazzi R, Vasu T, Hirani A. Dynamic changes in arterial waveform derived variables and fluid responsiveness in mechanically ventilated patients: a systematic review of the literature. Crit Care Med. 2009 Sep;37(9):2642-7. doi: 10.1097/CCM.0b013e3181a590da.
citation: Gershengorn HB, Garland A, Kramer A, Scales DC, Rubenfeld G, Wunsch H. Variation of arterial and central venous catheter use in United States intensive care units. Anesthesiology. 2014 Mar;120(3):650-64. doi: 10.1097/ALN.0000000000000008.
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citation: Kim SY, Lee JS, Kim WO, Sun JM, Kwon MK, Kil HK. Evaluation of radial and ulnar blood flow after radial artery cannulation with 20- and 22-gauge cannulae using duplex Doppler ultrasound. Anaesthesia. 2012 Oct;67(10):1138-45. doi: 10.1111/j.1365-2044.2012.07235.x. Epub 2012 Jul 16.
citation: Lazaro RP. Complex regional pain syndrome and acute carpal tunnel syndrome following radial artery cannulation: a neurological perspective and review of the literature. Medicine (Baltimore). 2015 Jan;94(3):e422. doi: 10.1097/MD.0000000000000422.
citation: Rasmy I, Mohamed H, Nabil N, Abdalah S, Hasanin A, Eladawy A, Ahmed M, Mukhtar A. Evaluation of Perfusion Index as a Predictor of Vasopressor Requirement in Patients with Severe Sepsis. Shock. 2015 Dec;44(6):554-9. doi: 10.1097/SHK.0000000000000481.
citation: Yamazaki H, Nishiyama J, Suzuki T. Use of perfusion index from pulse oximetry to determine efficacy of stellate ganglion block. Local Reg Anesth. 2012;5:9-14. doi: 10.2147/LRA.S30257. Epub 2012 Mar 13.