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Effect of Stellate Ganglion Block on Blood Flow in the Cannulated Radial Artery

Primary Purpose

Stellate Ganglion Block, Radial Artery Cannulation

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
USG stellate ganglion block
Sponsored by
Eslam Ayman Mohamed Shawki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stellate Ganglion Block focused on measuring stellate ganglion block, arterial cannula, ischemia, septic shock

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of medicine, Cairo University teaching hospitals (Kasr Alainy)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention group

Arm Description

In patients meeting the inclusion criteria and with absence of any exclusion criteria, and after taking PI and Doppler Blood flow values hourly for 3 hours (control values), the procedure for administering the USG Stellate ganglion block on the side of the arterial cannula will be started

Outcomes

Primary Outcome Measures

change in Perfusion Index (PI)
change in Perfusion Index (PI) in the cannulated limb before and after the Stellate ganglion block.

Secondary Outcome Measures

Perfusion Index (PI) after cannulation
Perfusion Index (PI) values bilaterally after radial arterial cannulation
Perfusion Index (PI) after Stellate ganglion block
Perfusion Index (PI) values bilaterally after Stellate ganglion block in the cannulated side.
Doppler Blood flow values after cannulation
Doppler Blood flow values in the both Radial arteries after cannulation of one of them.
Doppler Blood flow after Stellate ganglion block
Doppler Blood flow values in the both Radial arteries after Stellate ganglion block in the cannulated side.
Vasopressor drug dose
Doses of vasopressor drugs used.
Incidence of complications
Incidence of complications related to the Stellate ganglion block (Hematoma, Intravascular injection, Intrathecal injection, pneumothorax).
Incidence of ischemic complications
Incidence of ischemic complications related to the arterial cannula (Unilateral) or Vasopressors and general condition of the patient (Bilateral) (changes in the form of either color changes or definite gangrene).

Full Information

First Posted
February 1, 2017
Last Updated
June 19, 2017
Sponsor
Eslam Ayman Mohamed Shawki
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1. Study Identification

Unique Protocol Identification Number
NCT03042663
Brief Title
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

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
September 1, 2017 (Anticipated)
Study Completion Date
October 4, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eslam Ayman Mohamed Shawki

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stellate Ganglion Block, Radial Artery Cannulation
Keywords
stellate ganglion block, arterial cannula, ischemia, septic shock

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
In patients meeting the inclusion criteria and with absence of any exclusion criteria, and after taking PI and Doppler Blood flow values hourly for 3 hours (control values), the procedure for administering the USG Stellate ganglion block on the side of the arterial cannula will be started
Intervention Type
Procedure
Intervention Name(s)
USG stellate ganglion block
Intervention Description
After verification of proper needle position and aspiration to exclude vascular spread, 1mL of the injectate will be injected to see proper tissue spread as well as patient response. After one minute the remaining volume will be injected under real time ultrasound imaging.
Primary Outcome Measure Information:
Title
change in Perfusion Index (PI)
Description
change in Perfusion Index (PI) in the cannulated limb before and after the Stellate ganglion block.
Time Frame
After 30 minutes then every hour for 6 hours
Secondary Outcome Measure Information:
Title
Perfusion Index (PI) after cannulation
Description
Perfusion Index (PI) values bilaterally after radial arterial cannulation
Time Frame
3 hours
Title
Perfusion Index (PI) after Stellate ganglion block
Description
Perfusion Index (PI) values bilaterally after Stellate ganglion block in the cannulated side.
Time Frame
6 hours
Title
Doppler Blood flow values after cannulation
Description
Doppler Blood flow values in the both Radial arteries after cannulation of one of them.
Time Frame
3 hours
Title
Doppler Blood flow after Stellate ganglion block
Description
Doppler Blood flow values in the both Radial arteries after Stellate ganglion block in the cannulated side.
Time Frame
6 hours
Title
Vasopressor drug dose
Description
Doses of vasopressor drugs used.
Time Frame
6 hours
Title
Incidence of complications
Description
Incidence of complications related to the Stellate ganglion block (Hematoma, Intravascular injection, Intrathecal injection, pneumothorax).
Time Frame
6 hours
Title
Incidence of ischemic complications
Description
Incidence of ischemic complications related to the arterial cannula (Unilateral) or Vasopressors and general condition of the patient (Bilateral) (changes in the form of either color changes or definite gangrene).
Time Frame
6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eslam A Shawki, M.D.
Phone
+201225771017
Email
eslam.ayman@kasralainy.edu.eg
Facility Information:
Facility Name
Faculty of medicine, Cairo University teaching hospitals (Kasr Alainy)
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eslam A Shawki, M.D
Phone
'+201225771017
Email
eslam.ayman@kasralainy.edu.eg
First Name & Middle Initial & Last Name & Degree
Shereen M Amin, M,D
First Name & Middle Initial & Last Name & Degree
Ahmed Z Fouad, M.D
First Name & Middle Initial & Last Name & Degree
Ahmed S Abd El-Hameed

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19602972
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.
Results Reference
background
PubMed Identifier
24424071
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.
Results Reference
background
PubMed Identifier
12133178
Citation
Scheer B, Perel A, Pfeiffer UJ. Clinical review: complications and risk factors of peripheral arterial catheters used for haemodynamic monitoring in anaesthesia and intensive care medicine. Crit Care. 2002 Jun;6(3):199-204. doi: 10.1186/cc1489. Epub 2002 Apr 18.
Results Reference
background
PubMed Identifier
5516161
Citation
Glockner E, Harych H. [Guidelines for planning concerning physicians and stomatologists up to 1980]. Z Gesamte Hyg. 1970 Oct;16(10):811-22. No abstract available. German.
Results Reference
background
PubMed Identifier
22804619
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.
Results Reference
background
PubMed Identifier
25621693
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.
Results Reference
background
PubMed Identifier
26529657
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.
Results Reference
background
PubMed Identifier
22915896
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.
Results Reference
background

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Effect of Stellate Ganglion Block on Blood Flow in the Cannulated Radial Artery

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