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Central Line Study

A Randomized Study Comparing Two Techniques for Central Venous Catheter Insertion

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05534971
Enrollment
160
Registered
2022-09-10
Start date
2022-11-16
Completion date
2027-12-31
Last updated
2026-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shock

Brief summary

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.

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.

Interventions

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

Sponsors

Montefiore Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Only 1 attempt20 minutesThe frequency with which the central line can be placed with only one attempt will be summarized. Each attempt is defined by skin penetration

Secondary

MeasureTime frameDescription
Unable to place central line20 minutesThe 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.
Number of attempts20 minutesTotal number of required attempts (skin penetration) will be summarized by study arm.
Number of attempted guidewire passages20 minutesTotal 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.
Time taken for completion of the procedure20 minutesThe duration of time from skin penetration to wire out will be summarized by study arm using basic descriptive statistics.
Procedure-related adverse events20 minutesProcedure related adverse events including pneumothorax, incorrect vessel cannulation, and bleeding requiring application of pressure will be summarized by study arm.

Countries

United States

Contacts

Primary ContactJoe Offenbacher, MD
joseph.offenbacher@nyulangone.org646-929-7815
Backup ContactBenjamin Friedman, MD
bfriedm@montefiore.org718-920-6626

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026