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Recruiting NCT05534971

Central Line Study

Phase IV Interventional Shock

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Central venous catheter insertion.
Who it may be relevant to
Registry conditions: Shock. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Randomized Study Comparing Two Techniques for Central Venous Catheter Insertion

Overview

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

  • Procedure Central venous catheter insertion
    The clinical team will use the technique to establish central venous access

Primary outcome measures

  • Only 1 attempt [Time frame: 20 minutes]
Secondary outcome measures (5)
  • Unable to place central line [Time frame: 20 minutes]
  • Number of attempts [Time frame: 20 minutes]
  • Number of attempted guidewire passages [Time frame: 20 minutes]
  • Time taken for completion of the procedure [Time frame: 20 minutes]
  • Procedure-related adverse events [Time frame: 20 minutes]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Montefiore — The Bronx

Identifiers

NCT: NCT05534971 · 2022-14157

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗