Central Line InfectionCA-BSINCT01960556
Simulation-Based Central Venous Line Maintenance Bundle Education
An observational study of Central Line Infection, run by Children's Healthcare of Atlanta.
Trial summary
Catheter associated blood stream infections (CA-BSI) remain a source of significant morbidity and mortality in adult and pediatric critical care units. While it has been established that CVL maintenance bundles are pivotal to achieving and maintaining low CA-BSI rates, training and retention of proper bundle… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Central Line Infection
- What is being tested?
- Simulation Training
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to Jan 2012
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pediatric ICU nurses
Who may be able to join
- Any nurse assigned to the PICU on a regular basis was eligible to participate in the study, including full-time, part-time, and occasional (prn) PICU nursing staff, as well as central staffing office (ICU float nurses) and traveler nurses contracted to the PICU for a minimum of 12 weeks
Who cannot join
- Nurses floating from other units, agency nursing personnel, or traveler nurse contract of < 12 week period were excluded. Nurses on orientation were excluded until completion of introductory 6-month probation period
About this study
Official title: Simulation-Based Pediatric Intensive Care Unit Central Venous Line Maintenance Bundle Education
Catheter associated blood stream infections (CA-BSI) remain a source of significant morbidity and mortality in adult and pediatric critical care units. While it has been established that CVL maintenance bundles are pivotal to achieving and maintaining low CA-BSI rates, training and retention of proper bundle compliance remains a challenge.
The investigators prospectively compared this simulation-based program to a standard educational approach.
The investigators hypothesized that implementation of bedside simulation-based training of CVL dressing changes by registered nurses would improve CVL maintenance bundle compliance.
Read the detailed description
The 2006 NACHRI Quality Transformation Effort demonstrated that additional reduction in pediatric catheter associated blood stream infection (CA-BSI) rates could be achieved through improving compliance with maintenance bundle care for central lines. The investigators objective was to improve maintenance bundle compliance rates and nursing competency surrounding central venous line (CVL) care in their pediatric intensive care unit (PICU).
A multidisciplinary team developed a bedside simulation-based training program to improve compliance with standard PICU CVL maintenance bundle. The investigators then performed a randomized comparison study comparing a standard CVL bundle education process for bedside PICU nurses in a control group (CG) to an intervention group (IG) receiving bedside training to simulate a CVL dressing change and maintenance bundle followed by intermittent educational refresh. Groups were assessed for compliance with prescribed components of the CVL bundle maintenance (CVL score).
CVL scores will be compared between groups
- Conditions
- Central Line Infection
- Being tested
- Simulation Training
- Keywords
- simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation TrainingOther
Also called Education
Simulation training provided to one group
| Study group | Role | What they receive |
|---|---|---|
| Simulation | Simulation Training part of education Receives: Other: Simulation Training | |
| Non-Simulation Based Education | Did not receive simulation based education |
What is being measured
The primary outcome is the main question the study is designed to answer.
CVL scores
Change in CVL scores with and without simulation based education
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startDec 2010
- Primary completionDec 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central Line InfectionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kiran Hebbar, Children's Healthcare of Atlanta
- Investigators
- Kiran B Hebbar, MD, Principal investigator, Children's Healthcare of Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01960556
- Sponsor's protocol ID
- CA-BSI and Simulation
- Acronym
- CA-BSI
- Status last verified
- Oct 2013
- First submitted
- 7 Oct 2013
- Last updated
- 10 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Hebbar KB, Cunningham C, McCracken C, Kamat P, Fortenberry JD. Simulation-based paediatric intensive care unit central venous line maintenance bundle training. Intensive Crit Care Nurs. 2015 Feb;31(1):44-50. doi: 10.1016/j.iccn.2014.10.003. Epub 2014 Nov 22.
PubMed 25468293
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulation-Based Pediatric Intensive Care Unit Central Venous Line Maintenance Bundle Education
- ClinicalTrials.gov ID
- NCT01960556
- Acronym / sponsor ID
- CA-BSI / CA-BSI and Simulation
- Conditions
- Central Line Infection
- Keywords
- simulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 10 Oct 2013 (estimated)
- 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.
Catheter associated blood stream infections (CA-BSI) remain a source of significant morbidity and mortality in adult and pediatric critical care units. While it has been established that CVL maintenance bundles are pivotal to achieving and maintaining low CA-BSI rates, training and retention of proper bundle compliance remains a challenge.
The investigators prospectively compared this simulation-based program to a standard educational approach.
The investigators hypothesized that implementation of bedside simulation-based training of CVL dressing changes by registered nurses would improve CVL maintenance bundle compliance.
Detailed description
The 2006 NACHRI Quality Transformation Effort demonstrated that additional reduction in pediatric catheter associated blood stream infection (CA-BSI) rates could be achieved through improving compliance with maintenance bundle care for central lines. The investigators objective was to improve maintenance bundle compliance rates and nursing competency surrounding central venous line (CVL) care in their pediatric intensive care unit (PICU).
A multidisciplinary team developed a bedside simulation-based training program to improve compliance with standard PICU CVL maintenance bundle. The investigators then performed a randomized comparison study comparing a standard CVL bundle education process for bedside PICU nurses in a control group (CG) to an intervention group (IG) receiving bedside training to simulate a CVL dressing change and maintenance bundle followed by intermittent educational refresh. Groups were assessed for compliance with prescribed components of the CVL bundle maintenance (CVL score).
CVL scores will be compared between groups
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simulation | – | Other: Simulation TrainingSimulation Training part of education |
| Non-Simulation Based Education | – | –Did not receive simulation based education |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pediatric ICU nurses
Key inclusion criteria (1 listed)
- Any nurse assigned to the PICU on a regular basis was eligible to participate in the study, including full-time, part-time, and occasional (prn) PICU nursing staff, as well as central staffing office (ICU float nurses) and traveler nurses contracted to the PICU for a minimum of 12 weeks
Key exclusion criteria (1 listed)
- Nurses floating from other units, agency nursing personnel, or traveler nurse contract of < 12 week period were excluded. Nurses on orientation were excluded until completion of introductory 6-month probation period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulation TrainingAlso: EducationSimulation training provided to one group | Other | Simulation |
Primary outcome
CVL scores
Time frame: 12 months
Change in CVL scores with and without simulation based education
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 10 Oct 2013.
- Derived from this study: PubMed 25468293Hebbar KB, Cunningham C, McCracken C, Kamat P, Fortenberry JD. Simulation-based paediatric intensive care unit central venous line maintenance bundle training. Intensive Crit Care Nurs. 2015 Feb;31(1):44-50. doi: 10.1016/j.iccn.2014.10.003. Epub 2014 Nov 22.
Related trials for Central Line Infection
RecruitingPhase 3
Comparing The Safety And Efficacy Of DEFENCATH® In Reducing Central-Line Bloodstream Infections (CLABSIs) In Adults And Adolescent Participants Receiving Total Parenteral Nutrition Through A Central Venous Catheter (CVC)
Central Line Associated Blood Stream Infections (CLABSI)
Not yet recruitingObservational study
Central Line-Associated Bloodstream Infection QI Project
Central Line-associated Bloodstream Infection (CLABSI)
RecruitingObservational study
Using Microbial Genomics to Elucidate the Source of Central-line Associated Bloodstream Infections
Laboratory-confirmed Bloodstream Infection, Central Line-associated Bloodstream Infections
Not yet recruiting
Neonatal Catheter Lock for Infection Prevention
CLABSI - Central Line Associated Bloodstream Infection, CRBSI - Catheter Related Bloodstream Infection
Active, not recruitingObservational study
Impact of Disinfectant Caps on Nosocomial CLABSI
Central Line-associated Bloodstream Infections
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.
Kiran B Hebbar, MD principal investigator
Children's Healthcare of Atlanta
Questions about this trial
What is this clinical trial studying?
An observational study of Central Line Infection, run by Children's Healthcare of Atlanta.
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 1 inclusion and 1 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 10 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
CVL scores (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01960556, which also lists 1 linked publication.
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 10 Oct 2013; AzTrials last refreshed its copy on 27 Oct 2026.