Ultrasound Guided Central Venous Vascular Access - Novel Needle Navigation Technology Compared With Conventional Method

NCT03214575 | Completed DMC

• 1 other identifier: NMRR-16-334-29476
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Central venous catheter (CVC) insertion is a very common procedure in the intensive care setting. A recent international guidelines advocated the use of ultrasound for routine internal jugular CVC insertion. The needle navigation technology is a new innovation, also known as guided positioning system (GPS) which allows clinician to visualize the needle position and trajectory in real time as it approaches the target. We hypothesised that the use of GPS would increase success rate and decrease performance time in vascular access procedures. Objectives: To compare the success, efficacy and safety of the procedure using the ultrasound guidance (UG) with conventional versus GPS method. Methods: This was a prospective randomized controlled study in a single centre - intensive care unit. 100 patients were randomized into two groups (50 each each). Subjects would receive CVC insertion via internal jugular vein using ultrasound guidance out of plane approach by conventional versus GPS method. Outcomes measured were the procedure efficacy, safety, level of operators' experience and their satisfaction.

Conditions

Critically Ill

Keywords

Central Venous Vascular Access; Intensive Care Unit; Needle Navigation Technology

Outcome Measures

Primary Outcomes (1)

• The procedure efficacy justified by successful cannulation.

  The procedure efficacy justified by successful cannulation based on the performance time and number of attempts,

  0-120 seconds

Secondary Outcomes (2)

• Safety of procedure and complications.

  During and within 24 hours after procedure.

• Operators' satisfaction.

  within 1 week

Study Arms (2)

Conventional method

ACTIVE COMPARATOR

For the Conventional method of ultrasound guided central venous catheter insertion,we use the ultrasound machine, eZono 4000 and linear array transducer L3-12NGS (3-12 MHz)

Device: Conventional method

GPS method

EXPERIMENTAL

For the GPS method, we use the ultrasound machine, eZono 4000 with built-in adaptive needle recognition software called eZGuide (eZono, Jena, Germany) and linear array transducer L3-12NGS (3-12 MHz).

Procedure: GPS Method

Interventions

Conventional method DEVICE

Conventional method

GPS Method PROCEDURE

GPS method

Eligibility Criteria

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

You may qualify if:

• Patients in the ICU who required central venous vascular access.

You may not qualify if:

• Refusal to participate in this study by patient or their legal representative and patient with known history of difficult central venous access at internal jugular vein (IJV).

Sponsors & Collaborators

• University of Malaya: lead

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohd Shahnaz Hasan, MBBS

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: July 4, 2017
• First Posted: July 11, 2017
• Study Start: February 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 31, 2016
• Last Updated: July 11, 2017

Record last verified: 2017-07