Innovative Central Line Securement Device in the Pediatric Population

Not Applicable

Terminated

Conditions: Quality of Life
Central Line Complication
Central Line-Associated Infection
Central Line Sepsis
Short Gut Syndrome
Central Line Infection
Pediatric Disorder

Interventions: Device: Wearable Central Line Securement Device (Vest)
Other: Traditional Securement Dressing

Registration Number: NCT04522778

Lead Sponsor: Ryan St. Pierre-Hetz

Brief 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).

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 23

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Device	Traditional Securement Dressing	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.
Device	Wearable Central Line Securement Device (Vest)	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.
Traditional Securement Dressing	Traditional Securement Dressing	Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care.

Primary Outcome Measures

Name	Time	Method
Primary Outcome - Line Breaks	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 Infections	For a maximum of 1 year from enrollment	Number of line infections defined as a positive blood culture drawn from a central line.
Primary Outcome - Line Replacement	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.

Secondary Outcome Measures

Name	Time	Method
Have You Been Worried About the Safety of Your Child's Central Line?	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.	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.
Has Your Child Needed Help With Eating, Dressing, Washing or Using the Toilet?	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.	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.
How Has the Vest or Dressing Affected Your Child's Ability to Participate in Typical Activities With Peers or Siblings?	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.	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.
How Has the Vest or Dressing Affected Your Ability to Keep Your Child's Central Line Safe?	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.	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.
Are You Worried About Your Child's Current Health?	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.	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.
How Has the Vest or Dressing Affected Your Child's Ability to be Active?	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.	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.
Has Your Child Been Able to Take a Long Walk or Play?	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.	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.
Has the Vest or Dressing Enabled Your Child to be More Active?	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.	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.
How Has the Vest or Dressing Affected Your Ability as a Family to Participate in Daily Activities?	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.	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.
Has Your Child Been Able to Take a Short Walk Outside of the House?	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.	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.
Has Your Child Needed to Stay in Bed or a Chair During the Day?	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.	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.
Is Your Child Able to Socialize?	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.	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.
Does Having a Central Line Affect His or Her Learning at School?	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.	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.
Is Your Child Able to Take Part in Hobbies or Leisure Activities?	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.	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.
Is Your Child Able to do Sports/Exercise?	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.	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.
How Would You Rate Your Child's Ability to Cope With Day to Day Activities?	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.	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.
How Has Your Child's Quality-of-life Been Affected by Vest or Dressing?	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.	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.
How Has Your Child's Quality-of-life Been Affected by Their Underlying Illness?	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.	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.
Is Your Child Able to Attend School/Pre-school?	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.	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.
Does Having a Central Line Affect His/Her Participation in School?	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.	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.
Is Your Child Able to Feel Independent?	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.	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.
Has the Vest or Dressing Prevented Your Child From Tampering With or Touching the Central Line?	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.	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.
How Would You Rate Your Child's Quality of Life on a Scale of 1 to 10?	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.	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.
Has the Vest or Dressing Been Easy to Use?	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.	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.
Has the Vest or Dressing Been Comfortable to Wear?	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.	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.
Has the Vest or Dressing Kept You Child's Central Line Safe?	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.	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.
Has the Presence of a Central Line Affected Their Body Image?	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.	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.