Central Line ComplicationNCT04522778
Innovative Central Line Securement Device in the Pediatric Population
A study testing Wearable Central Line Securement Device (Vest) and Traditional Securement Dressing in people with Central Line Complication and Central Line Infection, run by Ryan St. Pierre-Hetz at 1 site in United States.
Trial summary
This study involves evaluating pediatric patients with central lines to determine differences in line complications and quality of life in those with a novel central line securement device (wrap) as compared to those who use a traditional securement device (dressing). Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Central Line Complication, Central Line Infection, Central Line-Associated Infection
- What is being tested?
- Wearable Central Line Securement Device (Vest) and Traditional Securement Dressing
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2020to 1 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with a central line ages 0-18 years old who have never worn a wearable central line securement device (vest) will be eligible for the study.
Who cannot join
- Those children who currently wear a central line securement device (vest)
- Children with central lines who are 19 years or older
- Those females with central lines and Tanner 2 breast or greater breast development as a wearable central line securement device (vest) will not fit properly to secure the central line and may increase the risk of the central line complications.
- If the patient does develop breast during the time of the study then the patient will no longer wear the wrap and will go back to securing their device in the traditional way. The investgators will still collect data on that patient and they will be evaluated in the device arm consistent with the intention to treat principle.
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
About this study
Official title: Innovative Central Line Securement Device: Line Complications and Quality of Life in the Pediatric Population as Compared to Traditional Securement Device
This study involves evaluating pediatric patients with central lines to determine differences in line complications and quality of life in those with a novel central line securement device (wrap) as compared to those who use a traditional securement device (dressing).
Read the detailed description
Children with central lines experience line breaks, line dislodgment's and line infections as a result of traditional securement techniques (dressings). These issues lead to the patients' increased health care utilization and possibly to restriction of movement and delayed development as the children are restricted in their home environment. The purpose of this study is to determine if a wearable central line securement device, can decrease the number of line breaks, line dislodgment and line infections as compared to traditional securement techniques. Events per month would be calculated for each arm before and after intervention and analyzed for treatment effect. The hypothesis is that the use of this wearable central line securement device can reduce line breaks, line dislodgment and line infections as compared to the traditional adhesive dressing. A secondary outcome for evaluation will be quality of life. This will be analyzed with a standardized quality of life survey and treatment effect will be reported as an ordinal odds ratio. Children are naturally active, however their activity is restricted by the parents given the delicate nature of their line. This study looks to see if quality of life can be improved a more secure wearable attachment device, as compared to traditional securement techniques.
- Conditions
- Central Line Complication, Central Line Infection, Central Line-Associated Infection, Central Line Sepsis, Short Gut Syndrome, Quality of Life
- Being tested
- Wearable Central Line Securement Device (Vest), Traditional Securement Dressing
- Medical subject headings
- Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable Central Line Securement Device (Vest)Device
The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.
Traditional Securement DressingOther
All subjects will use sterile dressings throughout the trial as this is the standard of care for central line securement. Subjects randomized to the dressing arm will continue to use standard of care sterile dressing as the only form of central line securement.
| Study group | Role | What they receive |
|---|---|---|
| Device | Experimental | Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. Receives: Device: Wearable Central Line Securement Device (Vest); Other: Traditional Securement Dressing |
| Traditional Securement Dressing | Active comparator | Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care. Receives: Other: Traditional Securement Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome - Line Breaks
Number of line breaks defined as any mechanical trauma to the line that required repair but not replacement of the line.
Measured: For a maximum of 1 year from enrollment
Primary Outcome - Line Replacement
Number of line replacements in which a line was removed from the patient and a new line was placed.
Measured: For a maximum of 1 year from enrollment
Primary Outcome - Line Infections
Number of line infections defined as a positive blood culture drawn from a central line.
Measured: For a maximum of 1 year from enrollment
Secondary outcomes (27)
How Has the Vest or Dressing Affected Your Ability as a Family to Participate in Daily Activities?
Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.
Measured: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
How Has the Vest or Dressing Affected Your Child's Ability to be Active?
Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.
Measured: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses for an individual was 5 over a 12 month period.
How Has the Vest or Dressing Affected Your Child's Ability to Participate in Typical Activities With Peers or Siblings?
Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.
Measured: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
How Has the Vest or Dressing Affected Your Ability to Keep Your Child's Central Line Safe?
Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better and 6 being non applicable. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.
Measured: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Have You Been Worried About the Safety of Your Child's Central Line?
Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.
Measured: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Has Your Child Been Able to Take a Long Walk or Play?
Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.
Measured: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Has Your Child Been Able to Take a Short Walk Outside of the House?
Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.
Measured: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Are You Worried About Your Child's Current Health?
Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.
Measured: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Has Your Child Needed to Stay in Bed or a Chair During the Day?
Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.
Measured: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Has Your Child Needed Help With Eating, Dressing, Washing or Using the Toilet?
Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.
Measured: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Is Your Child Able to Socialize?
Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.
Measured: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Is Your Child Able to do Sports/Exercise?
Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.
Measured: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Is Your Child Able to Attend School/Pre-school?
Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.
Measured: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Does Having a Central Line Affect His/Her Participation in School?
Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.
Measured: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Does Having a Central Line Affect His or Her Learning at School?
Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.
Measured: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Is Your Child Able to Take Part in Hobbies or Leisure Activities?
Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.
Measured: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Is Your Child Able to Feel Independent?
Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.
Measured: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Has the Vest or Dressing Been Easy to Use?
Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.
Measured: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Has the Vest or Dressing Been Comfortable to Wear?
Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.
Measured: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Has the Vest or Dressing Kept You Child's Central Line Safe?
Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.
Measured: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Has the Vest or Dressing Prevented Your Child From Tampering With or Touching the Central Line?
Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.
Measured: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Has the Vest or Dressing Enabled Your Child to be More Active?
Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.
Measured: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Has the Presence of a Central Line Affected Their Body Image?
Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-5 with 1 being much worse, 5 being much better. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.
Measured: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
How Would You Rate Your Child's Quality of Life on a Scale of 1 to 10?
Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from 1-10 with 1 being very bad, 10 being very good. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.
Measured: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
How Would You Rate Your Child's Ability to Cope With Day to Day Activities?
Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from -5 to 5 with -5 being very bad, 5 being very well. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.
Measured: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
How Has Your Child's Quality-of-life Been Affected by Vest or Dressing?
Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from -5 to 5 with -5 being very bad, 5 being very well. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.
Measured: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
How Has Your Child's Quality-of-life Been Affected by Their Underlying Illness?
Survey modified from Baxter Scale of Quality of Life. These surveys were completed by family members or patients. Responses were recorded as a likert scale from -5 to 5 with -5 being very bad, 5 being very well. Quality of life data was recorded using ordinal scales. Therefore, we compared responses to individual questions between the dressing group and vest group using ordinal logistic regression, adjusting for clustering of responses within a participant. We present the mean and standard deviation for all responses as well as the ordinal odds ratio and 95% confidence intervals for a unit change in response level for each question.
Measured: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start5 Nov 2020
- Primary completion15 Sep 2022
- Study completion1 May 2023
Why it stopped: Unable to meet enrollment targets
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Central Line ComplicationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with central lines ages 0-18 years old who have never worn a wearable central line securement device (vest) will be eligible for the study. Half of the participants will be randomized to the device arm while the other half of participants will be randomized to the non-device arm. They will be block randomized based on age upon enrollment. Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear. The study will follow participants prospectively for approximately one year (2020 - 2021).
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ryan St. Pierre-Hetz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ryan St. Pierre-Hetz, University of Pittsburgh
- Investigators
- Angelica Mazzarini, MD, Principal investigator, UPMC Children's Hospital of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522778
- Sponsor's protocol ID
- STUDY19010059
- Status last verified
- Jul 2024
- First submitted
- 17 Aug 2020
- Last updated
- 5 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hwang FR, Stavropoulos SW, Shlansky-Goldberg RD, Mondschein JI, Patel AA, Solomon JA, Itkin M, Soulen MC, Chittams JL, Trerotola SO. Tunneled infusion catheter breakage: frequency and repair kit outcomes. J Vasc Interv Radiol. 2008 Feb;19(2 Pt 1):201-6. doi: 10.1016/j.jvir.2007.08.030.
PubMed 18341949Lundgren IS, Zhou C, Malone FR, McAfee NG, Gantt S, Zerr DM. Central venous catheter repair is associated with an increased risk of bacteremia and central line-associated bloodstream infection in pediatric patients. Pediatr Infect Dis J. 2012 Apr;31(4):337-40. doi: 10.1097/INF.0b013e31823eeec5.
PubMed 22146741Cesaro S, Corro R, Pelosin A, Gamba P, Zadra N, Fusaro F, Pillon M, Cusinato R, Zampieri C, Magagna L, Cavaliere M, Tridello G, Zanon G, Zanesco L. A prospective survey on incidence and outcome of Broviac/Hickman catheter-related complications in pediatric patients affected by hematological and oncological diseases. Ann Hematol. 2004 Mar;83(3):183-8. doi: 10.1007/s00277-003-0796-9. Epub 2003 Nov 13.
PubMed 15064868Ullman AJ, Marsh N, Mihala G, Cooke M, Rickard CM. Complications of Central Venous Access Devices: A Systematic Review. Pediatrics. 2015 Nov;136(5):e1331-44. doi: 10.1542/peds.2015-1507. Epub 2015 Oct 12.
PubMed 26459655Peng C, Monagle P, Newall F. Clinical outcomes of management of CVAD occlusions. Arch Dis Child. 2011 Sep;96(9):885-7. doi: 10.1136/adc.2010.194969. Epub 2011 Mar 11.
PubMed 21398316Rey C, Alvarez F, De La Rua V, Medina A, Concha A, Diaz JJ, Menendez S, Los Arcos M, Mayordomo-Colunga J. Mechanical complications during central venous cannulations in pediatric patients. Intensive Care Med. 2009 Aug;35(8):1438-43. doi: 10.1007/s00134-009-1534-0. Epub 2009 Jun 16.
PubMed 19529913Winkler MF, DiMaria-Ghalili RA, Guenter P, Resnick HE, Robinson L, Lyman B, Ireton-Jones C, Banchik LH, Steiger E. Characteristics of a Cohort of Home Parenteral Nutrition Patients at the Time of Enrollment in the Sustain Registry. JPEN J Parenter Enteral Nutr. 2016 Nov;40(8):1140-1149. doi: 10.1177/0148607115586575. Epub 2015 May 13.
PubMed 25972431Burckhardt CS, Anderson KL. The Quality of Life Scale (QOLS): reliability, validity, and utilization. Health Qual Life Outcomes. 2003 Oct 23;1:60. doi: 10.1186/1477-7525-1-60.
PubMed 14613562Gimeno-Santos E, Raste Y, Demeyer H, Louvaris Z, de Jong C, Rabinovich RA, Hopkinson NS, Polkey MI, Vogiatzis I, Tabberer M, Dobbels F, Ivanoff N, de Boer WI, van der Molen T, Kulich K, Serra I, Basagana X, Troosters T, Puhan MA, Karlsson N, Garcia-Aymerich J; PROactive consortium. The PROactive instruments to measure physical activity in patients with chronic obstructive pulmonary disease. Eur Respir J. 2015 Oct;46(4):988-1000. doi: 10.1183/09031936.00183014. Epub 2015 May 28.
PubMed 26022965St Pierre-Hetz RE, Ackerman KS, Cercone AM, Yaworski JA, Callaway CW, Rudolph JA, Manole MD. A novel central line securement vest reduces line trauma and improves quality of life in patients with intestinal failure. JPGN Rep. 2026 Apr 20;7(3):416-421. doi: 10.1002/jpr3.70165. eCollection 2026 Aug.
PubMed 42499744
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Central Line Securement Device: Line Complications and Quality of Life in the Pediatric Population as Compared to Traditional Securement Device
- ClinicalTrials.gov ID
- NCT04522778
- Acronym / sponsor ID
- STUDY19010059
- Conditions
- Central Line Complication, Central Line Infection, Central Line-Associated Infection, Central Line Sepsis, Short Gut Syndrome, Quality of Life
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to meet enrollment targets
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Ryan St. Pierre-HetzUniversity, hospital or other
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 21 Aug 2020 (actual)
- Results
- Posted 5 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study involves evaluating pediatric patients with central lines to determine differences in line complications and quality of life in those with a novel central line securement device (wrap) as compared to those who use a traditional securement device (dressing).
Detailed description
Children with central lines experience line breaks, line dislodgment's and line infections as a result of traditional securement techniques (dressings). These issues lead to the patients' increased health care utilization and possibly to restriction of movement and delayed development as the children are restricted in their home environment. The purpose of this study is to determine if a wearable central line securement device, can decrease the number of line breaks, line dislodgment and line infections as compared to traditional securement techniques. Events per month would be calculated for each arm before and after intervention and analyzed for treatment effect. The hypothesis is that the use of this wearable central line securement device can reduce line breaks, line dislodgment and line infections as compared to the traditional adhesive dressing. A secondary outcome for evaluation will be quality of life. This will be analyzed with a standardized quality of life survey and treatment effect will be reported as an ordinal odds ratio. Children are naturally active, however their activity is restricted by the parents given the delicate nature of their line. This study looks to see if quality of life can be improved a more secure wearable attachment device, as compared to traditional securement techniques.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with central lines ages 0-18 years old who have never worn a wearable central line securement device (vest) will be eligible for the study. Half of the participants will be randomized to the device arm while the other half of participants will be randomized to the non-device arm. They will be block randomized based on age upon enrollment. Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear. The study will follow participants prospectively for approximately one year (2020 - 2021).
| Arm | Type | Receives |
|---|---|---|
| Device | Experimental | Device: Wearable Central Line Securement Device (Vest), Other: Traditional Securement DressingThose in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. |
| Traditional Securement Dressing | Active comparator | Other: Traditional Securement DressingThose is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care. |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients with a central line ages 0-18 years old who have never worn a wearable central line securement device (vest) will be eligible for the study.
Key exclusion criteria (4 listed)
- Those children who currently wear a central line securement device (vest)
- Children with central lines who are 19 years or older
- Those females with central lines and Tanner 2 breast or greater breast development as a wearable central line securement device (vest) will not fit properly to secure the central line and may increase the risk of the central line complications.
- If the patient does develop breast during the time of the study then the patient will no longer wear the wrap and will go back to securing their device in the traditional way. The investgators will still collect data on that patient and they will be evaluated in the device arm consistent with the intention to treat principle.
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 |
|---|---|---|
| Wearable Central Line Securement Device (Vest)The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects. | Device | Device |
| Traditional Securement DressingAll subjects will use sterile dressings throughout the trial as this is the standard of care for central line securement. Subjects randomized to the dressing arm will continue to use standard of care sterile dressing as the only form of central line securement. | Other | Device, Traditional Securement Dressing |
Primary outcome
Primary Outcome - Line Breaks
Time frame: For a maximum of 1 year from enrollment
Number of line breaks defined as any mechanical trauma to the line that required repair but not replacement of the line.
Primary Outcome - Line Replacement
Time frame: For a maximum of 1 year from enrollment
Number of line replacements in which a line was removed from the patient and a new line was placed.
Primary Outcome - Line Infections
Time frame: For a maximum of 1 year from enrollment
Number of line infections defined as a positive blood culture drawn from a central line.
27 secondary outcomes
How Has the Vest or Dressing Affected Your Ability as a Family to Participate in Daily Activities?
Time frame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
How Has the Vest or Dressing Affected Your Child's Ability to be Active?
Time frame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses for an individual was 5 over a 12 month period.
How Has the Vest or Dressing Affected Your Child's Ability to Participate in Typical Activities With Peers or Siblings?
Time frame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
How Has the Vest or Dressing Affected Your Ability to Keep Your Child's Central Line Safe?
Time frame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Have You Been Worried About the Safety of Your Child's Central Line?
Time frame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Has Your Child Been Able to Take a Long Walk or Play?
Time frame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Has Your Child Been Able to Take a Short Walk Outside of the House?
Time frame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Are You Worried About Your Child's Current Health?
Time frame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Has Your Child Needed to Stay in Bed or a Chair During the Day?
Time frame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Has Your Child Needed Help With Eating, Dressing, Washing or Using the Toilet?
Time frame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Is Your Child Able to Socialize?
Time frame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Is Your Child Able to do Sports/Exercise?
Time frame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Is Your Child Able to Attend School/Pre-school?
Time frame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Does Having a Central Line Affect His/Her Participation in School?
Time frame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Does Having a Central Line Affect His or Her Learning at School?
Time frame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Is Your Child Able to Take Part in Hobbies or Leisure Activities?
Time frame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Is Your Child Able to Feel Independent?
Time frame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Has the Vest or Dressing Been Easy to Use?
Time frame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Has the Vest or Dressing Been Comfortable to Wear?
Time frame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Has the Vest or Dressing Kept You Child's Central Line Safe?
Time frame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Has the Vest or Dressing Prevented Your Child From Tampering With or Touching the Central Line?
Time frame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Has the Vest or Dressing Enabled Your Child to be More Active?
Time frame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Has the Presence of a Central Line Affected Their Body Image?
Time frame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
How Would You Rate Your Child's Quality of Life on a Scale of 1 to 10?
Time frame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
How Would You Rate Your Child's Ability to Cope With Day to Day Activities?
Time frame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
How Has Your Child's Quality-of-life Been Affected by Vest or Dressing?
Time frame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
How Has Your Child's Quality-of-life Been Affected by Their Underlying Illness?
Time frame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18341949Hwang FR, Stavropoulos SW, Shlansky-Goldberg RD, Mondschein JI, Patel AA, Solomon JA, Itkin M, Soulen MC, Chittams JL, Trerotola SO. Tunneled infusion catheter breakage: frequency and repair kit outcomes. J Vasc Interv Radiol. 2008 Feb;19(2 Pt 1):201-6. doi: 10.1016/j.jvir.2007.08.030.
- Background: PubMed 22146741Lundgren IS, Zhou C, Malone FR, McAfee NG, Gantt S, Zerr DM. Central venous catheter repair is associated with an increased risk of bacteremia and central line-associated bloodstream infection in pediatric patients. Pediatr Infect Dis J. 2012 Apr;31(4):337-40. doi: 10.1097/INF.0b013e31823eeec5.
- Background: PubMed 15064868Cesaro S, Corro R, Pelosin A, Gamba P, Zadra N, Fusaro F, Pillon M, Cusinato R, Zampieri C, Magagna L, Cavaliere M, Tridello G, Zanon G, Zanesco L. A prospective survey on incidence and outcome of Broviac/Hickman catheter-related complications in pediatric patients affected by hematological and oncological diseases. Ann Hematol. 2004 Mar;83(3):183-8. doi: 10.1007/s00277-003-0796-9. Epub 2003 Nov 13.
- Background: PubMed 26459655Ullman AJ, Marsh N, Mihala G, Cooke M, Rickard CM. Complications of Central Venous Access Devices: A Systematic Review. Pediatrics. 2015 Nov;136(5):e1331-44. doi: 10.1542/peds.2015-1507. Epub 2015 Oct 12.
- Background: PubMed 21398316Peng C, Monagle P, Newall F. Clinical outcomes of management of CVAD occlusions. Arch Dis Child. 2011 Sep;96(9):885-7. doi: 10.1136/adc.2010.194969. Epub 2011 Mar 11.
- Background: PubMed 19529913Rey C, Alvarez F, De La Rua V, Medina A, Concha A, Diaz JJ, Menendez S, Los Arcos M, Mayordomo-Colunga J. Mechanical complications during central venous cannulations in pediatric patients. Intensive Care Med. 2009 Aug;35(8):1438-43. doi: 10.1007/s00134-009-1534-0. Epub 2009 Jun 16.
- Background: PubMed 25972431Winkler MF, DiMaria-Ghalili RA, Guenter P, Resnick HE, Robinson L, Lyman B, Ireton-Jones C, Banchik LH, Steiger E. Characteristics of a Cohort of Home Parenteral Nutrition Patients at the Time of Enrollment in the Sustain Registry. JPEN J Parenter Enteral Nutr. 2016 Nov;40(8):1140-1149. doi: 10.1177/0148607115586575. Epub 2015 May 13.
- Background: PubMed 14613562Burckhardt CS, Anderson KL. The Quality of Life Scale (QOLS): reliability, validity, and utilization. Health Qual Life Outcomes. 2003 Oct 23;1:60. doi: 10.1186/1477-7525-1-60.
- Background: PubMed 26022965Gimeno-Santos E, Raste Y, Demeyer H, Louvaris Z, de Jong C, Rabinovich RA, Hopkinson NS, Polkey MI, Vogiatzis I, Tabberer M, Dobbels F, Ivanoff N, de Boer WI, van der Molen T, Kulich K, Serra I, Basagana X, Troosters T, Puhan MA, Karlsson N, Garcia-Aymerich J; PROactive consortium. The PROactive instruments to measure physical activity in patients with chronic obstructive pulmonary disease. Eur Respir J. 2015 Oct;46(4):988-1000. doi: 10.1183/09031936.00183014. Epub 2015 May 28.
- Derived from this study: PubMed 42499744St Pierre-Hetz RE, Ackerman KS, Cercone AM, Yaworski JA, Callaway CW, Rudolph JA, Manole MD. A novel central line securement vest reduces line trauma and improves quality of life in patients with intestinal failure. JPGN Rep. 2026 Apr 20;7(3):416-421. doi: 10.1002/jpr3.70165. eCollection 2026 Aug.
- Individual participant dataSharing planned: No
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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.
Angelica Mazzarini, MD principal investigator
UPMC Children's Hospital of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable Central Line Securement Device (Vest) and Traditional Securement Dressing in people with Central Line Complication and Central Line Infection, run by Ryan St. Pierre-Hetz 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 1 inclusion and 4 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 5 Jul 2024. 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?
Yes. Results are posted in the registry (first posted 5 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Primary Outcome - Line Breaks (time frame: For a maximum of 1 year from enrollment). The study lists 3 primary outcomes in all. 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 NCT04522778, which also lists 10 linked publications.
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 5 Jul 2024.