Safety and Efficacy of Ultrasound Guided Vascular Access

Vascular access involves central and peripheral vein accesses and arterial accesses. Central venous catheterization is widely used in clinical practice for diverse purposes, including hemodialysis for end stage renal failure, invasive hemodynamic monitoring, radiological studies, infusion of drugs that cannot be administered via peripheral vessels, administration of parenteral nutrition, vascular access in patients whose peripheral veins are difficult to be catheterized and for miscellaneous purposes that require access to large caliber vessels.

Arterial cannulation is used for invasive arterial pressure monitoring and to ensure access for diagnostic and therapeutic interventions.

In the United States and United Kingdom, guidelines have recommended the use of ultrasound guidance to reduce complications and improve success in central venous catheterization.

Study Overview

• Status: Not yet recruiting
• Conditions: Vascular Access; Ultrasound Guided Vascular Access
• Intervention / Treatment: Device: ultrasound guided vascular access

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mostafa M Ahmed, resident; Phone Number: 002 01004115144; Email: mostafaelsayed@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• · Adult patients who need vascular access (arterial or venous)

Exclusion Criteria:

• · Patients with local infection in the area targeted for vascular access.

  • Patients with severe generalized infection and other skin diseases or lesions.
  • patients with history of DVT of the target vein and or pulmonary embolism.
  • Patients with untreated coagulopathy (INR >1.5 or platelets <50000mm3)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients need vascular access; Arterial or venous cathetrization guided by ultrasound	Device: ultrasound guided vascular access; Arterial or venous catheterization guided by ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse effects of ultrasound guided vascular access	Number of participants with adverse effects after ultrasound guided vascular access	one year

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: October 13, 2021
• First Submitted That Met QC Criteria: November 11, 2021
• First Posted (Actual): November 12, 2021

Study Record Updates

• Last Update Posted (Actual): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 13, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Soh-Med-21-10-25

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

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