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NCT04324970 Clinical Trial

Does the "TOOKIE Vest" Reduce Line Fall Out Rate in Children?

Childhood Cancer Clinical Trial

Official title:
A Prospective Study to Assess Whether the "Tookie Vest for Oncology" Reduces Central Line Fall Out Rate in the Paediatric Oncology Population

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04324970
Other study ID # R04675
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2019
Est. completion date September 6, 2020

Study information
Verified date November 2020
Source Manchester University NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of the trial is to assess whether the TOOKIE vest is an effective intervention in reducing line fall out. All oncology patients with a tunneled central line will be approached to participate in this study. Following informed consent they will be issued with a TOOKIE vest.

Description:

All oncology patients with a tunneled central line will be approached to participate in this study. Following informed consent they will be issued with a TOOKIE vest. Lines will be studied for the duration they are in situ. This will vary depending on the underlying diagnosis and treatment regime. One hundred central line insertions for oncology patients will be prospectively identified and be given the "TOOKIE Vest" to wear. Data will be collated for each group regarding age, gender, diagnosis, type of central access inserted, duration of line, reason for removal, in cases of infection the infected organism will be documented, date of each fall out.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date September 6, 2020
Est. primary completion date September 6, 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 16 Years
Eligibility Inclusion Criteria: - Any child receiving treatment for malignancy at Royal Manchester Children's Hospital - Patients with a tunnelled central line inserted for treatment of their malignancy Exclusion Criteria: • Any child having a portacath inserted as their mode of central access

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Tookie Vest
Tookie Vest

Locations
Country Name City State
United Kingdom Manchester University NHS Foundation Trust Manchester

Sponsors (1)
Lead Sponsor Collaborator
Manchester University NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Central line fall out rate approximately 1 year
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