Central Line Study

Phase 4

Recruiting

• Conditions: Shock

• Registration Number: NCT05534971
• Lead Sponsor: Montefiore Medical Center

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.

Study Timeline

• Study First Submitted: 2022-09-06
• Study First Submitted QC: 2022-09-06
• Study First Posted: 2022-09-10
• Study Start: 2022-11-16
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-24
• Last Update Posted: 2024-12-27
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Only 1 attempt	20 minutes	The frequency with which the central line can be placed with only one attempt will be summarized. Each attempt is defined by skin penetration

Secondary Outcome Measures

Name	Time	Method
Unable to place central line	20 minutes	The frequency with which the clinical team is unable to place the central line at that clinical site using the assigned technique will be summarized by study arm.
Number of attempts	20 minutes	Total number of required attempts (skin penetration) will be summarized by study arm.
Number of attempted guidewire passages	20 minutes	Total number of attempted guidewire passages, defined as the number of times a guidewire must be attempted to be passed, will be determined. Results will be summarized by study arm.
Time taken for completion of the procedure	20 minutes	The duration of time from skin penetration to wire out will be summarized by study arm using basic descriptive statistics.
Procedure-related adverse events	20 minutes	Procedure related adverse events including pneumothorax, incorrect vessel cannulation, and bleeding requiring application of pressure will be summarized by study arm.

Trial Locations

Locations (1)

Montefiore; 🇺🇸 Bronx, New York, United States