Central Line Study

A Randomized Study Comparing Two Techniques for Central Venous Catheter Insertion

Two different techniques for placing a central venous catheter will be compared.

Study Overview

• Status: Recruiting
• Conditions: Shock
• Intervention / Treatment: Procedure: Central venous catheter insertion

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Joe Offenbacher, MD; Phone Number: 646-929-7815; Email: joseph.offenbacher@nyulangone.org
• Study Contact Backup: Name: Benjamin Friedman, MD; Phone Number: 718-920-6626; Email: bfriedm@montefiore.org

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Recruiting
      • Montefiore
      • Contact: Benjamin Friedman, MD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

Adult patients in the emergency department who require ultrasound guided central line placement are eligible for participation and will be referred for participation in the study by the clinical team.

Exclusion Criteria:

• Inherited, acquired, or medication related coagulopathy or thrombocytopenia (platelets < 100,000). Patients will not be excluded for use of aspirin or other anti-platelet medication.
• Previous central venous access at the same anatomical site.
• Any indwelling catheter or wire that could potentially interfere with central line placement
• Anterior border of the target vein deeper than 3.5cm

Or for any clinical feature that would interfere with obtaining informed consent including dementia, delirium, or encephalopathy, as determined by the clinical attending physician.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard technique; The conventional hollow bore needle on a syringe will be used	Procedure: Central venous catheter insertion; The clinical team will use the technique to establish central venous access
Experimental: Peripheral IV; A peripheral intravenous catheter will be used to obtain initial central venous access	Procedure: Central venous catheter insertion; The clinical team will use the technique to establish central venous access

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Only 1 attempt	The frequency with which the central line can be placed with only one attempt. Each attempt is defined by skin penetration	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unable to place central line	The frequency with which the clinical team is unable to place the central line at that clinical site using the assigned technique.	20 minutes
Number of attempts	Total number of required attempts (skin penetration)	20 minutes
Time taken for completion of the procedure	Skin penetration to wire out	20 minutes

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: Benjamin J Friedman, MD, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 10, 2022

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2022-14157

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No