Central Venous Catheter Exit Site InfectionSCADNCT06310174
Study Examining the Effect of a Novel Cannulation Knife on User Satisfaction and Common Central Venous Catheter Insertion Complications
An observational study of Central Venous Catheter Exit Site Infection, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Venous Catheter Exit Site Infection
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2023to 25 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- Patient requires a 5 French, 7 French, or 12-14 French central venous catheter.
- Operator responsible for insertion of central venous catheter.
Who cannot join
- Patient unwilling to consent.
- Operator unwilling to complete the survey.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within one (1) hour post-procedure
Secondary outcomes (4)
Frequency of skin incision revisions.
Operator will answer: Did you have to revise the incision? Yes No
Measured: 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
Measured: 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?
Measured: Within one (1) hour post-procedure
Presence of a clean, dry dressing.
Is dressing dry, clean, and intact?
Measured: Within thirty-six hours (36) post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start22 Dec 2023
- Primary completion25 Mar 2025
- Study completion25 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Venous Catheter Exit Site InfectionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Gammie, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310174
- Sponsor's protocol ID
- IRB00362883
- Acronym
- SCAD
- Status last verified
- Mar 2026
- First submitted
- 7 Mar 2024
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Examining the Effect of a Novel Cannulation Knife on User Satisfaction and Common Central Venous Catheter Insertion Complications
- ClinicalTrials.gov ID
- NCT06310174
- Acronym / sponsor ID
- SCAD / IRB00362883
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 22 Dec 2023 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Patient requires a 5 French, 7 French, or 12-14 French central venous catheter.
- Operator responsible for insertion of central venous catheter.
Key exclusion criteria (2 listed)
- Patient unwilling to consent.
- Operator unwilling to complete the survey.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
User satisfaction with the new cannulation knife for CVC insertion.
Time frame: Within one (1) hour post-procedure
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.
4 secondary outcomes
Frequency of skin incision revisions.
Time frame: Within one (1) hour post-procedure
Frequency of procedures being aborted and restarted.
Time frame: Within one (1) hour post-procedure
Frequency of reverting to use of the scalpel normally used to make the incision.
Time frame: Within one (1) hour post-procedure
Presence of a clean, dry dressing.
Time frame: Within thirty-six hours (36) post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Gammie, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Venous Catheter Exit Site Infection, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
User satisfaction with the new cannulation knife for CVC insertion. (time frame: Within one (1) hour post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.