ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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Trial registered on ANZCTR

Registration number

ACTRN12615000738527

Ethics application status

Approved

Date submitted

30/06/2015

Date registered

17/07/2015

Date last updated

20/01/2016

Type of registration

Retrospectively registered

Titles & IDs

Public title

Replacing peripheral intravenous catheters: an observational study of peripheral intravenous catheter outcomes in adult hospitalised patients

Scientific title

Complication of peripheral intravenous catheters - a prospective observational study

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

REPLACE

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Peripheral intravenous catheter failure

Condition category

Condition code

Public Health

Health service research

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Patients with a peripheral intravenous catheter admitted to medical, surgical and maternity services, within the preceding 24 hour period will be identified prospectively. Consenting patients will have demographic data collected: e.g. admitting diagnosis, co-morbidities, skin and vein condition, cannula insertion details. Participants will be reviewed by a research nurse second daily and other risk factors collected: e.g. antibiotic type and dosage, flushing regime, continuous or intermittent intravenous fluid administration, dressing and other securement types of both catheter and tubing, presence of extension tubing or 3-way taps, catheter type and size, patient factors such as mobility status, presence of delirium. Participants will be monitored until discharge from hospital or until they have a central venous access device inserted.

Intervention code [1]

Not applicable

Comparator / control treatment

Not applicable - Observational study

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Peripheral intravenous catheter (PIVC) failure will be considered to have occurred if the catheter was an unplanned removal from any cause (includes infiltration, blockage, phlebitis, accidental removal or suspected infection). This information will be collected by the research nurse on second daily review from either direct observation, consultation with the clinical staff or review of medical record.

Timepoint [1]

Monitored on a second daily basis during hospital admission or until insertion of a CVL.

Secondary outcome [1]

Cost of catheter replacement

Timepoint [1]

This will be collected at the completion of study from information in our existing data set

Secondary outcome [2]

Length of hospital stay

Timepoint [2]

Date of discharge will coincide with date of discharge from study and be collected prospectively by research nurse, unless the patient has a CVL inserted, in which case this data will be collected retrospectively from medical records at study completion.

Secondary outcome [3]

Type of bacteria colonising peripheral catheters or on the skin will be collected from hospital records as per current clinical practice. A sub-study of a random 10% of PIVC and skin swabs will be collected at catheter removal. The skin swabs will be streaked onto blood agar, and IVD segments roll-plated.

Timepoint [3]

Type of bacteria colonising peripheral catheters will be collected by research nurse from medical records or the sub-study data set at the time of discharge or insertion of CVL.

Eligibility

Key inclusion criteria

1. Patients requiring peripheral intravenous catheters and able to provide informed consent
2. Catheter inserted within 24 hours of recruitment

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Patients admitted for palliative treatment or who are on a care of the dying pathway
2. Patients who are under the age of 18 years

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

15/10/2014

Actual

15/10/2014

Date of last participant enrolment

Anticipated

18/12/2015

Actual

26/11/2015

Date of last data collection

Anticipated

Actual

Sample size

Target

1000

Accrual to date

Final

1000

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Royal Brisbane & Womens Hospital - Herston

Recruitment postcode(s) [1]

4029 - Royal Brisbane Hospital

Funding & Sponsors

Funding source category [1]

University

Name [1]

Griffith Health Institute, Griffith University

Address [1]

170 Kessels Road, Nathan Qld 4111

Country [1]

Australia

Primary sponsor type

University

Name

Griffith University

Address

170 Kessels Road, Nathan Qld 4111

Country

Australia

Secondary sponsor category [1]

University

Name [1]

NHMRC Centre of research Excellence in Nursing Interventions for Hospitalised Patients (NCREN), Griffith University

Address [1]

Griffith University, Gold Coast campus, Southport, QLD 4222

Country [1]

Australia

Secondary sponsor category [2]

Commercial sector/Industry

Name [2]

Becton, Dickinson and Company (BD)

Address [2]

1 Becton Drive, Franklin Lakes, NJ 07417-1815

Country [2]

United States of America

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Brisbane and Women's Hospital, Human Reserach Ethics Committee

Ethics committee address [1]

Royal Brisbane and Women's Hospital
Level 7, Block 7,
Butterfield Street, Herston
QLD, 4029

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/02/2014

Approval date [1]

09/04/2014

Ethics approval number [1]

HREC/14/QRBW/76

Ethics committee name [2]

Griffith University Human Research Ethics Committee

Ethics committee address [2]

Office for Research 
Bray Centre
Nathan Campus
Griffith University
Kessels Rd, Nathan, 
QLD, 4111

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

24/04/2014

Approval date [2]

28/04/2014

Ethics approval number [2]

NRS/26/14/HREC

Summary

Brief summary

The rate of peripheral intravenous catheter failure at the RBWH is high (around 40%). When a catheter fails, before treatment has been completed, a new catheter is generally required, causing discomfort to the patient and considerable cost to the organisation. There are a number of reasons for catheter failure, some of which may be preventable with appropriate intervention. At present we do not have a clear idea of the causes of catheter failure at the RBWH. The proposed study will follow a cohort of patients from admission to discharge and closely monitor any IV access events associated with their stay. Patients with catheter failure will be compared to a group who do not have catheter failure, to identify opportunities for intervention.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Joan Webster

Address

Royal Brisbane and Women's Hospital
Centre for Clinical Nursing
Butterfield St
Herston, QLD, 4029
Australia

Country

Australia

Phone

+61736468111

Fax

joan.webster@health.qld.gov.au

Contact person for public queries

Name

Nicole Marsh

Address

Royal Brisbane and Women's Hospital
Centre for Clinical Nursing
Butterfield St
Herston, QLD, 4029
Australia

Country

Australia

Phone

+61736468740

Fax

nicole.marsh@health.qld.gov.au

Contact person for scientific queries

Name

Nicole Marsh

Address

Royal Brisbane and Women's Hospital
Centre for Clinical Nursing
Butterfield St
Herston, QLD, 4029
Australia

Country

Australia

Phone

+61736468740

Fax

nicole.marsh@health.qld.gov.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Prophylactic insertion of large bore peripheral intravenous catheters in maternity patients for postpartum haemorrhage: A cohort study.	2018	https://dx.doi.org/10.1111/ajo.12759

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically