Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001109291
Ethics application status
Approved
Date submitted
27/06/2018
Date registered
4/07/2018
Date last updated
11/06/2019
Date data sharing statement initially provided
11/06/2019
Date results information initially provided
11/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
An Australia and New Zealand-wide survey of extracorporeal membrane oxygen (ECMO)-related infection and dressing and securement practices.
Scientific title
An Australia and New Zealand-wide point prevalence study to determine extracorporeal membrane oxygenation (ECMO)-related infection rates and cannulae dressing and securement practices.
Secondary ID [1] 295288 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Extracorporeal membrane oxygenation 308472 0
Condition category
Condition code
Infection 307449 307449 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Days
Description of intervention(s) / exposure
Extracorporeal membrane oxygenation (ECMO) is an invasive mechanical therapy used to provide cardio-respiratory support to critically ill patients when maximal conventional support has failed. Nosocomial infection is one of the most frequent and serious complications of ECMO and is reported in up to 64% of patients. It leads to longer periods of mechanical ventilation and ECMO support, as well as longer hospital stays and increased mortality. ECMO is delivered via large-bore cannulas, which must be adequately secured both at the insertion site and along the length of the cannula to avoid complications such as cannula migration, dislodgement and local and systemic infection.
This point prevalence study will be a one week, observational study conducted over twelve separate weeks. Each study week will be separated by approximately one calendar month. On each study week, all sites will collect data for each eligible ECMO patient.
Intervention code [1] 301618 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306417 0
Prevalence of ECMO cannulation site infection (localised infection) as per hospital medical and pathology records.
Timepoint [1] 306417 0
From commencement of ECMO therapy until point prevalence day
Primary outcome [2] 306418 0
Prevalence of ECMO cannula-related blood stream infection as per hospital medical and pathology records.
Timepoint [2] 306418 0
From commencement of ECMO therapy until point prevalence day
Primary outcome [3] 306491 0
Prevalence of any other hospital-acquired infection as per hospital medical and pathology records.
Timepoint [3] 306491 0
On point prevalence data collection day
Secondary outcome [1] 348502 0
ECMO cannula dressing and securement practices as documented in medical records.
Timepoint [1] 348502 0
On point prevalence data collection days
Secondary outcome [2] 348816 0
Adherence to that ECMO centre's cannula dressing and securement guidelines as per medical records.
Timepoint [2] 348816 0
On point prevalence data collection days.

Eligibility
Key inclusion criteria
(1) Patients undergoing ECMO treatment with a circuit that includes a membrane oxygenator and pump
(2) Patients decannulated from ECMO <48 hours prior to data collection days
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Patients who have already had data captured on a previous data collection day
(2) Patients decannulated from ECMO for > 48 hours on data collection days
(3) ECMO circuit does not include a membrane oxygenator and pump

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
There is no sample size calculation necessary for this type of study. However we expect each site to have, on average, around 2 patients receiving ECMO at any given time, resulting in a cohort of around 110 patients. Most data will be analysed by basic descriptive statistics. Where appropriate, parametric and non-parametric tests will be used to make comparisons between subgroups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
26/09/2017
Date of last participant enrolment
Anticipated
26/08/2018
Actual
26/08/2018
Date of last data collection
Anticipated
26/08/2018
Actual
27/11/2018
Sample size
Target
110
Accrual to date
Final
127
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 11213 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 11214 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment hospital [3] 11215 0
Gold Coast University Hospital - Southport
Recruitment hospital [4] 11216 0
Westmead Hospital - Westmead
Recruitment hospital [5] 11217 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [6] 11218 0
The Alfred - Prahran
Recruitment hospital [7] 11219 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [8] 11220 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [9] 11256 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 23087 0
4032 - Chermside
Recruitment postcode(s) [2] 23088 0
4101 - South Brisbane
Recruitment postcode(s) [3] 23089 0
4215 - Southport
Recruitment postcode(s) [4] 23090 0
2145 - Westmead
Recruitment postcode(s) [5] 23091 0
3004 - Prahran
Recruitment postcode(s) [6] 23092 0
3052 - Parkville
Recruitment postcode(s) [7] 23093 0
4102 - Woolloongabba
Recruitment postcode(s) [8] 23133 0
2010 - Darlinghurst
Recruitment outside Australia
Country [1] 10582 0
New Zealand
State/province [1] 10582 0
Auckland

Funding & Sponsors
Funding source category [1] 299882 0
Charities/Societies/Foundations
Name [1] 299882 0
The Prince Charles Hospital Foundation
Country [1] 299882 0
Australia
Primary sponsor type
Hospital
Name
The Prince Charles Hospital
Address
Rode Road,
Chermside, QLD, 4032
Country
Australia
Secondary sponsor category [1] 299268 0
None
Name [1] 299268 0
Address [1] 299268 0
Country [1] 299268 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300751 0
Metro South Hospital and Health Service HREC
Ethics committee address [1] 300751 0
Princess Alexandra Hospital
Centres for Health Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba, QLD, 4102
Ethics committee country [1] 300751 0
Australia
Date submitted for ethics approval [1] 300751 0
07/07/2017
Approval date [1] 300751 0
24/08/2017
Ethics approval number [1] 300751 0
HREC/17/PAH/383

Summary
Brief summary
This project is a point prevalence study of ECMO-related infection and cannula dressing and securement practices in both adult and paediatric populations across Australia and New Zealand.
The aims of this project are to identify the following:
(1) Prevalence of ECMO cannulation site infection (local infection)
(2) Prevalence of ECMO-related bloodstream infection and other nosocomial infections
(3) ECMO cannula dressing and securement practices, and adherence to local dressing/securement guidelines
Data will be collected on each eligible patient on one day during the pre-specified data collection week. There will be one data collection week per month for 12 months. It is hypothesised that this data will give an accurate snapshot of the prevalence of nosocomial infections and of cannula dressing and securement practices across Australia and New Zealand in patients receiving ECMO.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84694 0
Ms Amanda Corley
Address 84694 0
Room 15, Level 3,
Clinical Sciences Building
The Prince Charles Hospital,
Rode Road,
Chermside, QLD, 4032
Country 84694 0
Australia
Phone 84694 0
+61 7 3139 5772
Fax 84694 0
Email 84694 0
[email protected]
Contact person for public queries
Name 84695 0
Ms Amanda Corley
Address 84695 0
Room 15, Level 3,
Clinical Sciences Building
The Prince Charles Hospital,
Rode Road,
Chermside, QLD, 4032
Country 84695 0
Australia
Phone 84695 0
+61 7 3139 5772
Fax 84695 0
Email 84695 0
[email protected]
Contact person for scientific queries
Name 84696 0
Ms Amanda Corley
Address 84696 0
Room 15, Level 3,
Clinical Sciences Building
The Prince Charles Hospital,
Rode Road,
Chermside, QLD, 4032
Country 84696 0
Australia
Phone 84696 0
+61 7 3139 5772
Fax 84696 0
Email 84696 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results.
When will data be available (start and end dates)?
Immediately following publication. No end date.
Available to whom?
On a case-by-case basis at the discretion of the Principal Investigator.
Available for what types of analyses?
IPD meta-analyses.
How or where can data be obtained?
Access subject to approval by the Principal Investigator.


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
SourceTitleYear of PublicationDOI
EmbaseNosocomial infection prevalence in patients undergoing extracorporeal membrane oxygenation (ECMO): Protocol for a point prevalence study across Australia and New Zealand.2019https://dx.doi.org/10.1136/bmjopen-2019-029293
N.B. These documents automatically identified may not have been verified by the study sponsor.