Evaluating a new knife for central venous catheter insertion
A Pilot Study Examining the Effect of a Novel Cannulation Knife on User Satisfaction and Common Central Venous Catheter Insertion Complications
This study tests a new knife for inserting central venous catheters to see if it makes the process easier and safer for doctors and their patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 144 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06310174 on ClinicalTrials.gov |
What this trial studies
This study aims to assess user satisfaction and the occurrence of complications associated with central venous catheter (CVC) insertion using a novel cannulation knife. A cohort of 24 clinicians will perform a total of 120 observed procedures across three clinical settings: the cardiovascular operating room, surgical intensive care unit, and interventional cardiology. The study will involve video recordings of procedures to document key variables, alongside clinician surveys to evaluate the knife's effectiveness and any complications encountered during the insertion process.
Who should consider this trial
Good fit: Ideal candidates include patients requiring a central venous catheter of specified sizes and whose operators are willing to participate in the study.
Not a fit: Patients who are unwilling to consent or whose operators do not complete the survey may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved satisfaction and reduced complications in central venous catheter insertions.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating this may be a novel evaluation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient requires a 5 French, 7 French, or 12-14 French central venous catheter. * Operator responsible for insertion of central venous catheter. Exclusion Criteria: * Patient unwilling to consent. * Operator unwilling to complete the survey.
Where this trial is running
Baltimore, Maryland
- Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: James Gammie, MD — Johns Hopkins University
- Study coordinator: Lisa Fornaresio, PhD
- Email: lisa.fornaresio@jhmi.edu
- Phone: 443.927.3984
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.