Clinical trial NCT06310174: Study Examining the Effect of a Novel Cannulation Knife on User Satisfaction and Common Central Venous Catheter Insertion Complications
Official title: A Pilot Study Examining the Effect of a Novel Cannulation Knife on User Satisfaction and Common Central Venous Catheter Insertion Complications
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Central Venous Catheter Exit Site Infection
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

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.

Primary outcomes:
measure: User satisfaction with the new cannulation knife for CVC insertion.
timeFrame: Within one (1) hour post-procedure
Secondary outcomes:
measure: Frequency of skin incision revisions.
timeFrame: Within one (1) hour post-procedure
measure: Frequency of procedures being aborted and restarted.
timeFrame: Within one (1) hour post-procedure
measure: Frequency of reverting to use of the scalpel normally used to make the incision.
timeFrame: Within one (1) hour post-procedure
measure: Presence of a clean, dry dressing.
timeFrame: Within thirty-six hours (36) post-procedure
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: James Gammie, MD
role: PRINCIPAL_INVESTIGATOR
References: