NCT05140668

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 14, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2022

Completed
Last Updated

June 30, 2022

Status Verified

June 1, 2022

Enrollment Period

4 months

First QC Date

November 14, 2021

Last Update Submit

June 26, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • to compare complications which result from supraclavicular or approaches for right subclavian venous catheter insertion

    7 months

Study Arms (2)

Supraclavicular central venous catheterization approach group

ACTIVE COMPARATOR

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

Infraclavicular central venous catheterization approach group

ACTIVE COMPARATOR

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

Interventions

Comparison between Supraclavicular And Infraclavicular Approach For Ultrasound-Guided Right Subclavian Venous Catheterization

Infraclavicular central venous catheterization approach groupSupraclavicular central venous catheterization approach group

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 22099008BACKGROUND
  • 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.

    PMID: 16204277BACKGROUND
  • 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.

    PMID: 22307320BACKGROUND
  • 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.

    PMID: 26595049BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Comparison between Supraclavicular And Infraclavicular Approach For Ultrasound-Guided Right Subclavian Venous Catheterization In Major Elective Surgeries And ICU Patients

Study Record Dates

First Submitted

November 14, 2021

First Posted

December 1, 2021

Study Start

October 10, 2021

Primary Completion

February 8, 2022

Study Completion

April 8, 2022

Last Updated

June 30, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will share

Locations