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Central Line Study

Montefiore Medicine Academic Health System logo

Montefiore Medicine Academic Health System

Status and phase

Enrolling
Phase 4

Conditions

Shock

Treatments

Procedure: Central venous catheter insertion

Study type

Interventional

Funder types

Other

Identifiers

NCT05534971
2022-14157

Details and patient eligibility

About

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.

Full 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.

Enrollment

160 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

160 participants in 2 patient groups

Standard technique
Active Comparator group
Description:
The conventional hollow bore needle on a syringe will be used
Treatment:
Procedure: Central venous catheter insertion
Peripheral IV
Experimental group
Description:
A peripheral intravenous catheter will be used to obtain initial central venous access
Treatment:
Procedure: Central venous catheter insertion

Trial contacts and locations

1

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Central trial contact

Joe Offenbacher, MD; Benjamin Friedman, MD

Data sourced from clinicaltrials.gov

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