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

NCT ID: NCT04324970

Last Updated: 2020-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-15

Study Completion Date

2020-09-06

Brief Summary

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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

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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.

Conditions

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Childhood Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Tookie vest

Participant issued with Tookie vest

Group Type EXPERIMENTAL

Tookie Vest

Intervention Type DEVICE

Tookie Vest

Interventions

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Tookie Vest

Tookie Vest

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Manchester University NHS Foundation Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ross Craigie

Role: PRINCIPAL_INVESTIGATOR

Manchester University NHS Foundation Trust

Locations

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Manchester University NHS Foundation Trust

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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R04675

Identifier Type: -

Identifier Source: org_study_id