Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310174
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-07
Brief Title:
Study Examining the Effect of a Novel Cannulation Knife on User Satisfaction and Common Central Venous Catheter Insertion Complications
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
A Pilot Study Examining the Effect of a Novel Cannulation Knife on User Satisfaction and Common Central Venous Catheter Insertion Complications
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCAD
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 devices 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 abortrestart 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
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 devices 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 abortrestart 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None