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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Central Venous Catheter Exit Site Infection

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.

• Study Type: Observational
• Enrollment (Estimated): 144

Contacts and Locations

• Study Contact: Name: Lisa Fornaresio, PhD; Phone Number: 443.927.3984; Email: lisa.fornaresio@jhmi.edu
• Study Contact Backup: Name: Zyriah Robinson; Phone Number: 443.927.3983; Email: zyriah.robsinson@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins Hospital
      • Principal Investigator: James Gammie, MD
      • Contact: Lisa Fornaresio, PhD; Phone Number: 443-927-3984; Email: lisa.fornaresio@jhmi.edu
      • Contact: Zyriah Robinson; Phone Number: 443.927.3983; Email: zyriah.robinson@jhmi.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

A prospective cohort of 100 clinicians will be enrolled.

The cannulation knife will be studied in three clinical areas:

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
User satisfaction with the new cannulation knife for CVC insertion.	Using a survey developed by the study team, Operators will rate the performance of the cannulation knife in regards to the ease of skin incision, ease of dilator insertion, device safety, and opinion on usage for central venous line (CVL) placement with ongoing cardiopulmonary resuscitation (CPR), using a Likert Scale (scores range from 1: significant benefit to 5: significant hindrance). The possible overall score ranges from four (4) to twenty (20), with a higher score indicating user dissatisfaction and hindrance.	Within one (1) hour post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of skin incision revisions.	Operator will answer: Did you have to revise the incision? Yes No	Within one (1) hour post-procedure
Frequency of procedures being aborted and restarted.	Operator will answer: Did you have to abort the procedure and start over? Yes No	Within one (1) hour post-procedure
Frequency of reverting to use of the scalpel normally used to make the incision.	Did you have to revert to using an #11 blade?	Within one (1) hour post-procedure
Presence of a clean, dry dressing.	Is dressing dry, clean, and intact?	Within thirty-six hours (36) post-procedure

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: James Gammie, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2023
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: March 7, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IRB00362883

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No