Central Line Study

NCT ID: NCT05534971

Last Updated: 2024-12-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-16
• Study Completion Date: 2027-12-31

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.

Conditions

Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Standard technique

The conventional hollow bore needle on a syringe will be used

Group Type: ACTIVE_COMPARATOR

Central venous catheter insertion

Intervention Type: PROCEDURE

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

Peripheral IV

A peripheral intravenous catheter will be used to obtain initial central venous access

Group Type: EXPERIMENTAL

Central venous catheter insertion

Intervention Type: PROCEDURE

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

Interventions

Central venous catheter insertion

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin J Friedman, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

Montefiore

The Bronx, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Joe Offenbacher, MD

Role: CONTACT

Phone: 646-929-7815

Email: joseph.offenbacher@nyulangone.org

Benjamin Friedman, MD

Role: CONTACT

Phone: 718-920-6626

Email: bfriedm@montefiore.org

Facility Contacts

Benjamin Friedman, MD

Role: primary

Other Identifiers

2022-14157

Identifier Type: -

Identifier Source: org_study_id