Central Line Study

Shock Clinical Trial

Official title:

A Randomized Study Comparing Two Techniques for Central Venous Catheter Insertion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05534971
• Other study ID #: 2022-14157
• Status: Recruiting
• Phase: Phase 4
• Start date: November 16, 2022
• Est. completion date: December 2027

Study information

• Verified date: December 2023
• Source: Montefiore Medical Center
• Contact: Joe Offenbacher, MD
• Phone: 646-929-7815
• Email: joseph.offenbacher[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Two different techniques for placing a central venous catheter will be compared.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Shock

Intervention

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

Locations

Country	Name	City	State
United States	Montefiore	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Only 1 attempt	The frequency with which the central line can be placed with only one attempt. Each attempt is defined by skin penetration	20 minutes
Secondary	Unable to place central line	The frequency with which the clinical team is unable to place the central line at that clinical site using the assigned technique.	20 minutes
Secondary	Number of attempts	Total number of required attempts (skin penetration)	20 minutes
Secondary	Time taken for completion of the procedure	Skin penetration to wire out	20 minutes