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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05140668
Other study ID # soh-med-21-11-06
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 10, 2021
Est. completion date April 8, 2022

Study information

Verified date June 2022
Source Sohag University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 210
Est. completion date April 8, 2022
Est. primary completion date February 8, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 79 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Sohag University Hospital Sohag

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (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. — View Citation

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. Review. — View Citation

Konner K. History of vascular access for haemodialysis. Nephrol Dial Transplant. 2005 Dec;20(12):2629-35. Epub 2005 Oct 4. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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