Stellate Ganglion BlockNCT03042663
Effect of Stellate Ganglion Block on Blood Flow in the Cannulated Radial Artery
A study testing USG stellate ganglion block in people with Stellate Ganglion Block and Radial Artery Cannulation, run by Eslam Ayman Mohamed Shawki at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stellate Ganglion Block, Radial Artery Cannulation
- What is being tested?
- USG stellate ganglion block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2016to 4 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range of 18-80 years.
- Septic shock patients on vasopressor support (Nor-epinephrine or epinephrine).
- Presence of an indication for an arterial cannula.
Who cannot join
- 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).
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine, Cairo University teaching hospitals (Kasr Alainy)
Cairo
Eslam A Shawki, M.D, '+201225771017, eslam.ayman@kasralainy.edu.eg
Shereen M Amin, M,D
About this study
Official title: Effect of Stellate Ganglion Block on Blood Flow in the Cannulated Radial Artery in Septic Shock Patients on Vasopressors, A Feasibility Study
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.
Read the 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.
- Conditions
- Stellate Ganglion Block, Radial Artery Cannulation
- Being tested
- USG stellate ganglion block
- Keywords
- stellate ganglion block, arterial cannula, ischemia, septic shock
- Medical subject headings
- Ischemia, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
USG stellate ganglion blockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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 Receives: Procedure: USG stellate ganglion block |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Perfusion Index (PI)
change in Perfusion Index (PI) in the cannulated limb before and after the Stellate ganglion block.
Measured: After 30 minutes then every hour for 6 hours
Secondary outcomes (7)
Perfusion Index (PI) after cannulation
Perfusion Index (PI) values bilaterally after radial arterial cannulation
Measured: 3 hours
Perfusion Index (PI) after Stellate ganglion block
Perfusion Index (PI) values bilaterally after Stellate ganglion block in the cannulated side.
Measured: 6 hours
Doppler Blood flow values after cannulation
Doppler Blood flow values in the both Radial arteries after cannulation of one of them.
Measured: 3 hours
Doppler Blood flow after Stellate ganglion block
Doppler Blood flow values in the both Radial arteries after Stellate ganglion block in the cannulated side.
Measured: 6 hours
Vasopressor drug dose
Doses of vasopressor drugs used.
Measured: 6 hours
Incidence of complications
Incidence of complications related to the Stellate ganglion block (Hematoma, Intravascular injection, Intrathecal injection, pneumothorax).
Measured: 6 hours
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).
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start1 Mar 2016
- Primary completion1 Sep 2017 (estimated)
- Study completion4 Oct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Stellate Ganglion BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eslam Ayman Mohamed Shawki
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eslam Ayman Mohamed Shawki, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042663
- Sponsor's protocol ID
- StArt
- Status last verified
- Jun 2017
- First submitted
- 1 Feb 2017
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19602972Gershengorn 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.
PubMed 24424071Scheer 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.
PubMed 12133178Glockner 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.
PubMed 5516161Kim 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.
PubMed 22804619Lazaro 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.
PubMed 25621693Rasmy 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.
PubMed 26529657Yamazaki 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.
PubMed 22915896
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Stellate Ganglion Block on Blood Flow in the Cannulated Radial Artery in Septic Shock Patients on Vasopressors, A Feasibility Study
- ClinicalTrials.gov ID
- NCT03042663
- Acronym / sponsor ID
- StArt
- Conditions
- Stellate Ganglion Block, Radial Artery Cannulation
- Keywords
- stellate ganglion block, arterial cannula, ischemia, septic shock
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Eslam Ayman Mohamed ShawkiUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 1 Sep 2017 (estimated)
- Study completion
- 4 Oct 2017 (estimated)
- First posted
- 3 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: USG stellate ganglion blockIn 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age range of 18-80 years.
- Septic shock patients on vasopressor support (Nor-epinephrine or epinephrine).
- Presence of an indication for an arterial cannula.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| USG stellate ganglion blockAfter 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. | Procedure or surgery | Intervention group |
Primary outcome
change in Perfusion Index (PI)
Time frame: After 30 minutes then every hour for 6 hours
change in Perfusion Index (PI) in the cannulated limb before and after the Stellate ganglion block.
7 secondary outcomes
Perfusion Index (PI) after cannulation
Time frame: 3 hours
Perfusion Index (PI) after Stellate ganglion block
Time frame: 6 hours
Doppler Blood flow values after cannulation
Time frame: 3 hours
Doppler Blood flow after Stellate ganglion block
Time frame: 6 hours
Vasopressor drug dose
Time frame: 6 hours
Incidence of complications
Time frame: 6 hours
Incidence of ischemic complications
Time frame: 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
- Background: PubMed 19602972Marik 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.
- Background: PubMed 24424071Gershengorn 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.
- Background: PubMed 12133178Scheer 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.
- Background: PubMed 5516161Glockner 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.
- Background: PubMed 22804619Kim 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.
- Background: PubMed 25621693Lazaro 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.
- Background: PubMed 26529657Rasmy 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.
- Background: PubMed 22915896Yamazaki 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing USG stellate ganglion block in people with Stellate Ganglion Block and Radial Artery Cannulation, run by Eslam Ayman Mohamed Shawki at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eslam A Shawki, M.D. (+201225771017, eslam.ayman@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Perfusion Index (PI) (time frame: After 30 minutes then every hour for 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03042663, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2017.