Central Line Study

NCT05534971 | Recruiting Phase 4 DMC FDA Device

• 1 other identifier: 2022-14157
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Shock

Outcome Measures

Primary Outcomes (1)

• Only 1 attempt

  The frequency with which the central line can be placed with only one attempt will be summarized. Each attempt is defined by skin penetration

  20 minutes

Secondary Outcomes (5)

• Unable to place central line

  20 minutes

• Number of attempts

  20 minutes

• Number of attempted guidewire passages

  20 minutes

• Time taken for completion of the procedure

  20 minutes

• Procedure-related adverse events

  20 minutes

Study Arms (2)

Standard technique

ACTIVE COMPARATOR

The conventional hollow bore needle on a syringe will be used

Procedure: Central venous catheter insertion

Peripheral IV

EXPERIMENTAL

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

Procedure: Central venous catheter insertion

Interventions

Central venous catheter insertion PROCEDURE

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

Peripheral IV; Standard technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore

The Bronx, New York, 10467, United States

RECRUITING

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Benjamin J Friedman, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joe Offenbacher, MD

CONTACT

646-929-7815; joseph.offenbacher@nyulangone.org

Benjamin Friedman, MD

CONTACT

718-920-6626; bfriedm@montefiore.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 10, 2022
• Study Start: November 16, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)