NCT04324970

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 27, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2020

Completed
Last Updated

November 27, 2020

Status Verified

November 1, 2020

Enrollment Period

1.6 years

First QC Date

March 16, 2020

Last Update Submit

November 25, 2020

Conditions

Childhood Cancer

Outcome Measures

Primary Outcomes (1)

  • Central line fall out rate

    approximately 1 year

Study Arms (1)

Tookie vest

EXPERIMENTAL

Participant issued with Tookie vest

Device: Tookie Vest

Interventions

Tookie VestDEVICE

Tookie Vest

Tookie vest

Eligibility Criteria

Age0 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Any child receiving treatment for malignancy at Royal Manchester Children's Hospital
  • Patients with a tunnelled central line inserted for treatment of their malignancy

You may not qualify if:

  • Any child having a portacath inserted as their mode of central access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Ross Craigie

    Manchester University NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2020

First Posted

March 27, 2020

Study Start

January 15, 2019

Primary Completion

September 6, 2020

Study Completion

September 6, 2020

Last Updated

November 27, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)