Clinical trial NCT05534971: Central Line Study
Official title: A Randomized Study Comparing Two Techniques for Central Venous Catheter Insertion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Shock
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2022-09-10
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Only 1 attempt
timeFrame: 20 minutes
Secondary outcomes:
measure: Unable to place central line
timeFrame: 20 minutes
measure: Number of attempts
timeFrame: 20 minutes
measure: Number of attempted guidewire passages
timeFrame: 20 minutes
measure: Time taken for completion of the procedure
timeFrame: 20 minutes
measure: Procedure-related adverse events
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Benjamin J Friedman, MD
role: PRINCIPAL_INVESTIGATOR
References: