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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05534971
Other study ID # 2022-14157
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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