Study Examining the Effect of a Novel Cannulation Knife on User Satisfaction and Common Central Venous Catheter Insertion Complications

NCT ID: NCT06310174

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 144 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-22
• Study Completion Date: 2027-05-31

Brief Summary

The purpose of this study is to assess user satisfaction and the frequency of common central venous catheter insertion complications when using a novel cannulation knife.

Detailed Description

The primary objective is to assess user satisfaction with a new cannulation knife for central venous catheter (CVC) insertion. Secondary objectives include assessing the frequency of skin incision revisions, frequency of procedures being aborted and restarted, frequency of reverting to the use of the scalpel customarily used to make the incision, frequency of bleeding around the catheter after completion of the procedure, assessment of time to final catheter placement, and the frequency of central line-associated bloodstream infections (CLABSI).

The cannulation knife will be studied in three clinical areas:

• Cardiovascular Operating Room
• Cardiovascular Surgical Intensive Care Unit
• Interventional Cardiology

A prospective cohort of 24 clinicians will be enrolled. Each clinician will be asked to perform a total of five observed cannulations, resulting in a combined 120 observed procedures.

In cases where both the clinician and patient are amenable, a video recording will be taken of the procedure to document the study variables of interest (duration of the procedure, need for revisions, the incidence of bleeding, size of the final incision, etc.) and allow for later review.

All clinicians will be given a survey. This survey is designed to assess the clinicians impression of the device's benefit and the need for 1) revisions of the incision or, 2) aborting the initial attempt. Clinicians will also be timed from procedure start to final catheter placement and will be monitored for incidence of common complications (back bleeding around the catheter, need to revise incision, need to abort/restart procedure) and need to revert to use of a standard scalpel. Although clinicians are the primary focus of this investigation, patients will also be consented to the study and will be monitored for the development of CLABSI post-procedure.

Conditions

Central Venous Catheter Exit Site Infection

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Gammie, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lisa Fornaresio, PhD

Role: CONTACT

lisa.fornaresio@jhmi.edu

443.927.3984

Zyriah Robinson

Role: CONTACT

zyriah.robsinson@jhmi.edu

443.927.3983

Facility Contacts

Lisa Fornaresio, PhD

Role: primary

lisa.fornaresio@jhmi.edu

443-927-3984

Zyriah Robinson

Role: backup

zyriah.robinson@jhmi.edu

443.927.3983

Other Identifiers

IRB00362883

Identifier Type: -

Identifier Source: org_study_id