Congenital DisordersNCT00366314
Frequency of Accessing Central Lines for Blood Samples
An observational study of Congenital Disorders, run by Children's Healthcare of Atlanta at 1 site in United States.
Trial summary
The purpose of this study is to quantify and analyze the line accesses for each of the 3 participating ICUs. The hypothesis is that the CICU will have a significantly higher number of line accesses than the other units. Read more about this study
- Who is it for?
- Ages 30 days to 18 years
- Conditions the study is for
- Congenital Disorders
- How many people
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to not given
- 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 30 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ICUs at Egleston Hospital, Children's Healthcare of Atlanta
- June 1, 2003 - June 30, 2006
- ICU LOS between 14 and 28 days
- Central access
- 30 days to 18 years
Who cannot join
- Those who do not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
About this study
Official title: Frequency of Accessing Central Lines for Blood Samples and Medication Administration: A Comparison Between CICU, PICU and NICU
The purpose of this study is to quantify and analyze the line accesses for each of the 3 participating ICUs.
The hypothesis is that the CICU will have a significantly higher number of line accesses than the other units. Analyzing the data will assist the researchers in identifying best practices and ultimately, reduce the BSI rate in the CICU.
Read the detailed description
The CICU is participating in the system wide initiative to decrease blood stream infections (BSIs). In January 2006, the BSI rate in the CICU at Children's, Egleston peaked at 18.2 (rate of infections per 1000 catheter days). The BSI Bundles (processes of care) were rolled out on January 16, 2006 according to CHCA guidelines (Child Health Corporation of America). The Children's February BSI rate remained high at 16.3 despite the bundle implementation. The target goal is to maintain a rate below 3.7 which was realized only in March with a rate of 3.4. Subsequent months were 5.4 and 4.9. (See attached graph).
A separate research study is currently being conducted by Nicole Jarrell, in collaboration with Drs. Kevin Maher and Agustin Rubio, to determine risk factors for contracting a BSI by analyzing the past 200 infections (positive blood cultures) in the CICU. Preliminary findings in this study indicate a particularly high risk patient population, those with delayed sternal closures (open chests).
Results from this study indicate that of the 95 patients (January, 2004-February, 2006) with open chests, 28 developed BSIs (29.5%). This was compared to neonates undergoing cardiac bypass surgery with closed chests. This patient population had a significantly lower BSI rate at 9.1% (n=9 of 99). The largest subset of patients in these groups are the neonates with HLHS (Hypoplastic Left Heart Syndrome) undergoing the Norwood procedure. Upon reviewing all HLHS/Norwood patients, those with open chests (N=40) have a 32.5% infection rate compared to the closed chests (N=20) at 20%.
Multiple risk factors are assumed to contribute to the high risk and rate of infection in the CICU patient population. One risk that has been substantiated during a quality improvement project conducted in the CICU is related to accessing lines. The number of times that the patient's central and arterial lines are entered for blood sampling and medication administration was analyzed utilizing chart review of a small sample group of CICU patients (n=29). For these 29 patients, their lines were accessed 5476 times during their CICU LOS (length of stay). The average CICU LOS was 7.4 days. Of the 29 patients, 3 had open chests with an average duration of 7 days open.
The average times the line was accessed for the duration of LOS was 189 times at a rate of 13 per shift. When the patient LOS was >5 days (n=11 with an average LOS of 16 days), the total average increased to 455 times during the LOS, but per shift averages remained the same at 13.
This preliminary data indicates that the frequency of accessing lines in the CICU is a significant risk factor for cardiac ICU patients for acquiring a BSI.
Benchmarking of BSI rates against the other ICUs (PICU and NICU at Egleston) indicate the CICU has the highest infection rate of the ICUs. First quarter mean rates are as follows:
- CICU=12.9
- NICU=2.9
- PICU=0
Differences in demographics of high risk patients are a factor in the differentiation between the units, however, there are also known specific differences in practice. Further analysis of specific practices related to minimizing infection risks are necessary to determine the best practices. This includes the frequency and specific reasons for accessing patients' central lines which is the focus of this study.
One primary difference in practice is related to the use of additional respiratory monitoring which allows for reduction in the number of blood samples for blood gas analysis. Another significant difference is in the utilization of medication drips instead of bolus medications, thus reducing the number of times the line is entered to administer medications. Although these practice differences are known, the actual impact on the patient by reducing the number of accesses to the lines and therefore reducing the risk of BSI, is unknown.
- Conditions
- Congenital Disorders
- Keywords
- Blood samples, Medication administration, CICU, PICU, NICU
- Medical subject headings
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2006 (estimated)
- Study startJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital DisordersStudies 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
- Defined population
- Time perspective
- Retrospective
- Enrolment
- 320 participants
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Investigators
- Nicole M Jarrell, RNC, MSN, Principal investigator, Children's Healthcare of Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00366314
- Sponsor's protocol ID
- 06-142
- Status last verified
- Jun 2007
- First submitted
- 17 Aug 2006
- Last updated
- 13 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Accessing Central Lines for Blood Samples and Medication Administration: A Comparison Between CICU, PICU and NICU
- ClinicalTrials.gov ID
- NCT00366314
- Acronym / sponsor ID
- 06-142
- Conditions
- Congenital Disorders
- Keywords
- Blood samples, Medication administration, CICU, PICU, NICU
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 320 participants
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Study start
- Jun 2003
- First posted
- 21 Aug 2006 (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.
The purpose of this study is to quantify and analyze the line accesses for each of the 3 participating ICUs.
The hypothesis is that the CICU will have a significantly higher number of line accesses than the other units. Analyzing the data will assist the researchers in identifying best practices and ultimately, reduce the BSI rate in the CICU.
Detailed description
The CICU is participating in the system wide initiative to decrease blood stream infections (BSIs). In January 2006, the BSI rate in the CICU at Children's, Egleston peaked at 18.2 (rate of infections per 1000 catheter days). The BSI Bundles (processes of care) were rolled out on January 16, 2006 according to CHCA guidelines (Child Health Corporation of America). The Children's February BSI rate remained high at 16.3 despite the bundle implementation. The target goal is to maintain a rate below 3.7 which was realized only in March with a rate of 3.4. Subsequent months were 5.4 and 4.9. (See attached graph).
A separate research study is currently being conducted by Nicole Jarrell, in collaboration with Drs. Kevin Maher and Agustin Rubio, to determine risk factors for contracting a BSI by analyzing the past 200 infections (positive blood cultures) in the CICU. Preliminary findings in this study indicate a particularly high risk patient population, those with delayed sternal closures (open chests).
Results from this study indicate that of the 95 patients (January, 2004-February, 2006) with open chests, 28 developed BSIs (29.5%). This was compared to neonates undergoing cardiac bypass surgery with closed chests. This patient population had a significantly lower BSI rate at 9.1% (n=9 of 99). The largest subset of patients in these groups are the neonates with HLHS (Hypoplastic Left Heart Syndrome) undergoing the Norwood procedure. Upon reviewing all HLHS/Norwood patients, those with open chests (N=40) have a 32.5% infection rate compared to the closed chests (N=20) at 20%.
Multiple risk factors are assumed to contribute to the high risk and rate of infection in the CICU patient population. One risk that has been substantiated during a quality improvement project conducted in the CICU is related to accessing lines. The number of times that the patient's central and arterial lines are entered for blood sampling and medication administration was analyzed utilizing chart review of a small sample group of CICU patients (n=29). For these 29 patients, their lines were accessed 5476 times during their CICU LOS (length of stay). The average CICU LOS was 7.4 days. Of the 29 patients, 3 had open chests with an average duration of 7 days open.
The average times the line was accessed for the duration of LOS was 189 times at a rate of 13 per shift. When the patient LOS was >5 days (n=11 with an average LOS of 16 days), the total average increased to 455 times during the LOS, but per shift averages remained the same at 13.
This preliminary data indicates that the frequency of accessing lines in the CICU is a significant risk factor for cardiac ICU patients for acquiring a BSI.
Benchmarking of BSI rates against the other ICUs (PICU and NICU at Egleston) indicate the CICU has the highest infection rate of the ICUs. First quarter mean rates are as follows:
- CICU=12.9
- NICU=2.9
- PICU=0
Differences in demographics of high risk patients are a factor in the differentiation between the units, however, there are also known specific differences in practice. Further analysis of specific practices related to minimizing infection risks are necessary to determine the best practices. This includes the frequency and specific reasons for accessing patients' central lines which is the focus of this study.
One primary difference in practice is related to the use of additional respiratory monitoring which allows for reduction in the number of blood samples for blood gas analysis. Another significant difference is in the utilization of medication drips instead of bolus medications, thus reducing the number of times the line is entered to administer medications. Although these practice differences are known, the actual impact on the patient by reducing the number of accesses to the lines and therefore reducing the risk of BSI, is unknown.
Study design
- Observational model
- Defined population
- Time perspective
- Retrospective
Who may qualify
- Ages
- 30 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- ICUs at Egleston Hospital, Children's Healthcare of Atlanta
- June 1, 2003 - June 30, 2006
- ICU LOS between 14 and 28 days
- Central access
- 30 days to 18 years
Key exclusion criteria (1 listed)
- Those who do not meet inclusion criteria
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
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2007.
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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.
Nicole M Jarrell, RNC, MSN principal investigator
Children's Healthcare of Atlanta
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 Congenital Disorders, run by Children's Healthcare of Atlanta 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 5 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: stopped early, as of the sponsor's last update on 13 Jun 2007. 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 was stopped early. Results are not available in the source record.
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.
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 13 Jun 2007.