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NCT Number: NCT05534971

Central Line Study

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Montefiore

The Bronx, New York, 10467, United States

Location status: Recruiting

Location contact

Benjamin Friedman, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Central venous catheter insertion

Procedure

The clinical team will use the technique to establish central venous access

Primary outcomes

  1. Only 1 attempt

    Time frame: 20 minutes

    The frequency with which the central line can be placed with only one attempt will be summarized. Each attempt is defined by skin penetration

Secondary outcomes

  1. Unable to place central line

    Time frame: 20 minutes

    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.

  2. Number of attempts

    Time frame: 20 minutes

    Total number of required attempts (skin penetration) will be summarized by study arm.

  3. Number of attempted guidewire passages

    Time frame: 20 minutes

    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.

  4. Time taken for completion of the procedure

    Time frame: 20 minutes

    The duration of time from skin penetration to wire out will be summarized by study arm using basic descriptive statistics.

  5. Procedure-related adverse events

    Time frame: 20 minutes

    Procedure related adverse events including pneumothorax, incorrect vessel cannulation, and bleeding requiring application of pressure will be summarized by study arm.

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin Friedman, MD

CONTACT

[email protected]

718-920-6626

Joe Offenbacher, MD

CONTACT

[email protected]

646-929-7815

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

A Randomized Study Comparing Two Techniques for Central Venous Catheter Insertion

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Sep 10, 2022
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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