Comparison Between Supraclavicular And Infraclavicular Approach For Right Subclavian Venous Catheterization

Comparison Between Supraclavicular And Infraclavicular Approach For Ultrasound-Guided Right Subclavian Venous Catheterization In Major Elective Surgeries And ICU Patients

A central venous catheter (CVC) is an indwelling device that is peripherally inserted into a larg central vein for a multitude of indications in major elective surgeries and ICU patients and now it's now with notable advance is the adjunct of ultrasound guidance, which has recently become the standard of care for CVCs placed in wanted site to decreases the complications

Study Overview

• Status: Completed
• Conditions: Central Line Complication
• Intervention / Treatment: Device: Comparison between Supraclavicular And Infraclavicular Approach For Ultrasound-Guided Right Subclavian Venous Catheterization

Detailed Description

A central venous catheter (CVC) is an indwelling device that is peripherally inserted into a large, central vein (most commonly the internal jugular, subclavian, or femoral) and advanced until the terminal lumen resides within the inferior vena cava, superior vena cava, or right atrium.for a multitude of indications including; total parenteral nutrition administration dialysis, plasmapheresis , medication administration, hemodynamic monitoring and to facilitate further complex interventions such as transvenous pacemaker placement inserted with Seldinger's technique. A notable advance is the adjunct of ultrasound guidance, which has recently become the standard of care for CVCs placed in wanted site owing to associated decreases in complications e.g. arterial puncture, haematoma formation, pneumothorax, haemothorax and catheterization failure and an increase in first-pass success.

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt
    • Sohag University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria adult patients aged 20-79 y old who required central venous catheterization for : total parenteral nutrition administration dialysis plasmapheresis medication administration hemodynamic monitoring

Exclusion Criteria:

• Patient refusel Irritable patient Infection at the puncture site medical devices (chemoport, pacemaker,etc.) at the puncture site. right subclavian venous thrombosis haemostatic disorders current anticoagulant medication prescriptions previous history of surgery that might distort the anatomy of the right subclavian vein.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Supraclavicular central venous catheterization approach group; supraclavicular central venous catheterization group catheter is inserted in supraclavicular fossa (an indentation immediately above the clavicle) with a long-axis in plane approach	Device: Comparison between Supraclavicular And Infraclavicular Approach For Ultrasound-Guided Right Subclavian Venous Catheterization; Comparison between Supraclavicular And Infraclavicular Approach For Ultrasound-Guided Right Subclavian Venous Catheterization
ACTIVE_COMPARATOR: Infraclavicular central venous catheterization approach group; infraclavicular central venous catheterization group catheter is inserted in infraclavicular fossa (an indentation, immediately below the clavicle, above the third rib and between the deltoid muscle laterally and medioclavicular line medially) with a short-axis out-of-plane approach	Device: Comparison between Supraclavicular And Infraclavicular Approach For Ultrasound-Guided Right Subclavian Venous Catheterization; Comparison between Supraclavicular And Infraclavicular Approach For Ultrasound-Guided Right Subclavian Venous Catheterization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
to compare between the Supraclavicular and infraclavicular approach in right subclavian vein catheterization as regard accessibility sonar guided and number of punctures which is needed and the time of the procedure	After successful venous puncture, catheterization was attempted with the Seldinger's technique The guidewire and dilator were inserted to a depth of 10-15 cm and to the depth of venous puncture, respectively. We considered an attempt at catheterization as 'failed' if successful catheterization was not achieved within 3 min or If an anesthetist failed to catheterize the patient successfully within three attempts in 210 patients	7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
to compare complications which result from supraclavicular or approaches for right subclavian venous catheter insertion	monitoring of complications which can result from any of the two approaches e.g. arterial puncture, haematoma formation, pneumothorax, haemothorax it can monitored Clinically , blood gases and Chest X-Ray in 210 patients	7 months

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• Beheshti MV. A concise history of central venous access. Tech Vasc Interv Radiol. 2011 Dec;14(4):184-5. doi: 10.1053/j.tvir.2011.05.002.
• Konner K. History of vascular access for haemodialysis. Nephrol Dial Transplant. 2005 Dec;20(12):2629-35. doi: 10.1093/ndt/gfi168. Epub 2005 Oct 4.
• American Society of Anesthesiologists Task Force on Central Venous Access; Rupp SM, Apfelbaum JL, Blitt C, Caplan RA, Connis RT, Domino KB, Fleisher LA, Grant S, Mark JB, Morray JP, Nickinovich DG, Tung A. Practice guidelines for central venous access: a report by the American Society of Anesthesiologists Task Force on Central Venous Access. Anesthesiology. 2012 Mar;116(3):539-73. doi: 10.1097/ALN.0b013e31823c9569. No abstract available.
• Suess EM, Pinsky MR. Hemodynamic Monitoring for the Evaluation and Treatment of Shock: What Is the Current State of the Art? Semin Respir Crit Care Med. 2015 Dec;36(6):890-8. doi: 10.1055/s-0035-1564874. Epub 2015 Nov 23.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 10, 2021
• Primary Completion (ACTUAL): February 8, 2022
• Study Completion (ACTUAL): April 8, 2022

Study Registration Dates

• First Submitted: November 14, 2021
• First Submitted That Met QC Criteria: November 16, 2021
• First Posted (ACTUAL): December 1, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 26, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: soh-med-21-11-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No