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

NCT06310174 | Completed DMC

• 1 other identifier: IRB00362883
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Venous Catheter Exit Site Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Frequency of skin incision revisions.

  Within one (1) hour post-procedure

• Frequency of procedures being aborted and restarted.

  Within one (1) hour post-procedure

• Frequency of reverting to use of the scalpel normally used to make the incision.

  Within one (1) hour post-procedure

• Presence of a clean, dry dressing.

  Within thirty-six hours (36) post-procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patient requires a 5 French, 7 French, or 12-14 French central venous catheter.
• Operator responsible for insertion of central venous catheter.

You may not qualify if:

• Patient unwilling to consent.
• Operator unwilling to complete the survey.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Study Officials

• James Gammie, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 15, 2024
• Study Start: December 22, 2023
• Primary Completion: March 25, 2025
• Study Completion: March 25, 2025
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

US (1)