NCT04522778

Innovative Central Line Securement Device in the Pediatric Population

Terminated NA Results posted Last updated 5 July 2024

What this trial tests

NA trial testing Wearable Central Line Securement Device (Vest) in Central Line Complication in 23 participants. Terminated before completion.

Timeline

5 November 2020

Primary endpoint
15 September 2022

1 May 2023

Quick facts

Lead sponsor	Ryan St. Pierre-Hetz
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	23
Start date	5 November 2020
Primary completion	15 September 2022
Estimated completion	1 May 2023
Sites	1 location across United States

Drugs / interventions tested

• Wearable Central Line Securement Device (Vest)
• Traditional Securement Dressing

Conditions studied

• Central Line Complication — all drugs for Central Line Complication →
• Central Line Infection — all drugs for Central Line Infection →
• Central Line-Associated Infection — all drugs for Central Line-Associated Infection →
• Central Line Sepsis — all drugs for Central Line Sepsis →

Sponsor

Ryan St. Pierre-Hetz

Who can join

Adults 0 to 18, any sex, with Central Line Complication or Central Line Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Primary Outcome - Line Breaks Primary · 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.

Group	Value	95% CI
Device	.05	± .09
Traditional Securement Dressing	.05	± .07

Primary Outcome - Line Replacement Primary · 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.

Group	Value	95% CI
Device	.076	± .15
Traditional Securement Dressing	.05	± .16

Primary Outcome - Line Infections Primary · For a maximum of 1 year from enrollment

Number of line infections defined as a positive blood culture drawn from a central line.

Group	Value	95% CI
Device	.086	± .12
Traditional Securement Dressing	.075	± .12

How Has the Vest or Dressing Affected Your Ability as a Family to Participate in Daily Activities? Secondary · 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 chan

Group	Value	95% CI
Device	3.82	± .982
Traditional Securement Dressing	2.875	± .712

How Has the Vest or Dressing Affected Your Child's Ability to be Active? Secondary · 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 chan

Group	Value	95% CI
Device	3.45	± 1.06
Traditional Securement Dressing	3.78	± 1.02

How Has the Vest or Dressing Affected Your Child's Ability to Participate in Typical Activities With Peers or Siblings? Secondary · 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 chan

Group	Value	95% CI
Device	3.86	± 1.10
Traditional Securement Dressing	2.74	± 0.73

How Has the Vest or Dressing Affected Your Ability to Keep Your Child's Central Line Safe? Secondary · 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% confidenc

Group	Value	95% CI
Device	4.03	± 1.12
Traditional Securement Dressing	3.23	± 0.80

Have You Been Worried About the Safety of Your Child's Central Line? Secondary · 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 chan

Group	Value	95% CI
Device	2.42	± 1.2
Traditional Securement Dressing	2.84	± 1.02

Has Your Child Been Able to Take a Long Walk or Play? Secondary · 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 chan

Group	Value	95% CI
Device	3.37	± .82
Traditional Securement Dressing	3.41	± .87

Has Your Child Been Able to Take a Short Walk Outside of the House? Secondary · 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 chan

Group	Value	95% CI
Device	3.68	± .79
Traditional Securement Dressing	3.52	± .89

Are You Worried About Your Child's Current Health? Secondary · 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 chan

Group	Value	95% CI
Device	2.61	± 0.99
Traditional Securement Dressing	2.74	± 1.15

Has Your Child Needed to Stay in Bed or a Chair During the Day? Secondary · 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 chan

Group	Value	95% CI
Device	1.19	± .51
Traditional Securement Dressing	1.4	± .76

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.