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

NCT03042663 | Unknown

• 1 other identifier: StArt
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Stellate Ganglion Block; Radial Artery Cannulation

Keywords

stellate ganglion block; arterial cannula; ischemia; septic shock

Outcome Measures

Primary Outcomes (1)

• change in Perfusion Index (PI)

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

  After 30 minutes then every hour for 6 hours

Secondary Outcomes (7)

• Perfusion Index (PI) after cannulation

  3 hours

• Perfusion Index (PI) after Stellate ganglion block

  6 hours

• Doppler Blood flow values after cannulation

  3 hours

• Doppler Blood flow after Stellate ganglion block

  6 hours

• Vasopressor drug dose

  6 hours

Study Arms (1)

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

Procedure: USG stellate ganglion block

Interventions

USG stellate ganglion block PROCEDURE

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eslam Ayman Mohamed Shawki: lead

Study Sites (1)

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

Cairo, Egypt

RECRUITING

Related Publications (8)

• 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.

  PMID: 19602972 BACKGROUND

• 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.

  PMID: 24424071 BACKGROUND

• 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.

  PMID: 12133178 BACKGROUND

• 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.

  PMID: 5516161 BACKGROUND

• 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.

  PMID: 22804619 BACKGROUND

• 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.

  PMID: 25621693 BACKGROUND

• 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.

  PMID: 26529657 BACKGROUND

• 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.

  PMID: 22915896 BACKGROUND

MeSH Terms

Conditions

Ischemia; Shock, Septic

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock

Central Study Contacts

Eslam A Shawki, M.D.

CONTACT

+201225771017; eslam.ayman@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of anesthesia, SICU & Pain Management

Model Details: 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.

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 3, 2017
• Study Start: March 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: October 4, 2017
• Last Updated: June 21, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)