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. The studyu team hypothesizes that clinicians randomized to the peripheral catheter technique will have higher first attempt success rates, fewer procedural complications, and a shorter mean time to procedure completion than physicians assigned to wire through hollow bore needle.

Study Overview

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

Detailed Description

Central venous catheterization (CVC) is a lifesaving procedure carried out by emergency and acute care physicians to access proximal blood vessels in order to deliver medications, blood products and other resuscitative agents. Typically, this access is achieved by threading a wire through a hollow bore needle and then placing the central venous catheter over the wire. This procedure, called the Seldinger technique, results in the cannulation of the femoral or internal jugular veins. Nowadays, physicians use concurrent ultrasound guidance rather than an anatomic landmark-based approach to increase the success rate of central venous catheterization. The wire through hollow bore needle approach requires the use of two hands to hold the needle in the vessel in order to pass a guidewire. When done under ultrasound guidance, this requires dropping the ultrasound probe in order to have both hands available to achieve vessel cannulation.

Recent research has demonstrated that cannulation of central veins can be obtained by first using a peripheral intravenous catheter rather than a hollow bore needle. This technique requires just one hand, thereby allowing the physician to continue use of the ultrasound. Furthermore, the peripheral intravenous catheter is more stable within the vein than the hollow bore needle and less likely than the needle to damage the vessel wall when the catheter is jiggled. This is the same technique used to place mid-lines, a hybrid technique that incorporates the Seldinger technique and a peripheral intravenous catheter.

• 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
    • The 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 will be summarized. 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 will be summarized by study arm.	20 minutes
Number of attempts	Total number of required attempts (skin penetration) will be summarized by study arm.	20 minutes
Number of attempted guidewire passages	Total number of attempted guidewire passages, defined as the number of times a guidewire must be attempted to be passed, will be determined. Results will be summarized by study arm.	20 minutes
Time taken for completion of the procedure	The duration of time from skin penetration to wire out will be summarized by study arm using basic descriptive statistics.	20 minutes
Procedure-related adverse events	Procedure related adverse events including pneumothorax, incorrect vessel cannulation, and bleeding requiring application of pressure will be summarized by study arm.	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 (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: January 3, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock
• 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