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

Central Venous Catheter Exit Site Infection Clinical Trial

— SCAD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06310174
• Other study ID #: IRB00362883
• Status: Recruiting
• Start date: December 22, 2023
• Est. completion date: May 2027

Study information

• Verified date: March 2024
• Source: Johns Hopkins University
• Contact: Lisa Fornaresio, PhD
• Phone: 443.927.3984
• Email: lisa.fornaresio[@]jhmi.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: May 2027
• Est. primary completion date: March 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Central Venous Catheter Exit Site Infection

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Frequency of skin incision revisions.	Operator will answer: Did you have to revise the incision? Yes No	Within one (1) hour post-procedure
Secondary	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
Secondary	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
Secondary	Presence of a clean, dry dressing.	Is dressing dry, clean, and intact?	Within thirty-six hours (36) post-procedure