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

Primary Purpose

Childhood Cancer

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Tookie Vest
Sponsored by
Manchester University NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Childhood Cancer

Eligibility Criteria

0 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Manchester University NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tookie vest

Arm Description

Participant issued with Tookie vest

Outcomes

Primary Outcome Measures

Central line fall out rate

Secondary Outcome Measures

Full Information

First Posted
March 16, 2020
Last Updated
November 25, 2020
Sponsor
Manchester University NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04324970
Brief Title
Does the "TOOKIE Vest" Reduce Line Fall Out Rate in Children?
Official Title
A Prospective Study to Assess Whether the "Tookie Vest for Oncology" Reduces Central Line Fall Out Rate in the Paediatric Oncology Population
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
September 6, 2020 (Actual)
Study Completion Date
September 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Manchester University NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tookie vest
Arm Type
Experimental
Arm Description
Participant issued with Tookie vest
Intervention Type
Device
Intervention Name(s)
Tookie Vest
Intervention Description
Tookie Vest
Primary Outcome Measure Information:
Title
Central line fall out rate
Time Frame
approximately 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ross Craigie
Organizational Affiliation
Manchester University NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manchester University NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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