Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000191695
Ethics application status
Approved
Date submitted
10/02/2014
Date registered
21/02/2014
Date last updated
21/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Foot and lower limb complications following the use of extracorporeal membrane oxygenation (ECMO): The FECMO Study. A single centre retrospective observational study.
Scientific title
The FECMO Study: A single centre retrospective observational study/chart audit to determine pre and peri-Extracorporeal membrane oxygenation (ECMO) explanatory variables, and the rates of foot and lower limb complications following the use of ECMO in a major tertiary hospital between 2008-2012.
Secondary ID [1] 284067 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischaemia
 291123 0
Neuropathy 291124 0
Foot wounds 291125 0
Foot pressure injuries 291154 0
Lower limb amputation 291155 0
Condition category
Condition code
Skin 291466 291466 0 0
Other skin conditions
Infection 291467 291467 0 0
Other infectious diseases
Neurological 291468 291468 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients receiving Extracorporeal membrane oxygenation (ECMO) for respiratory and/or cardiovascular failure. Observing neurovascular status, medications, offloading/pressure relieving stratergies used, foot ulceration/amputation, acute and chronic co-morbidies pre, peri and post (30 days) ECMO intervention. This data is collected via retrospective chart audit for patients receiving intervention between 01/01/2008-31/12/2012.
Intervention code [1] 288760 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291446 0
To determine Pre & peri-Extracorporeal membrane oxygenation (ECMO) explanatory varibales such as age, gender, BMI, cannulation site, size of cannula, co-morbidities, prescence of H1N1 or H1N2 infection, clinical signs of peripheral lower limb ischaemia, neuropathy &/or wounds pre-ECMO intervention. This will be done via a retrospective chart audit.
Timepoint [1] 291446 0
Pre-ECMO intervention
Secondary outcome [1] 306783 0
Clinical signs/confirmed diagnosis of peripheral lower limb ischaemia post-ECMO intervention (up to 30 days post intervention) via retrospective chart audit.
Timepoint [1] 306783 0
30 days post ECMO treatment
Secondary outcome [2] 306836 0
Neuropathy post-ECMO intervention (up to 30 days post intervention) via retrospective chart audit.
Timepoint [2] 306836 0
30 days post intervention of ECMO
Secondary outcome [3] 306837 0
Wounds post-ECMO intervention (up to 30 days post intervention) via retrospective chart audit.
Timepoint [3] 306837 0
30 days post ECMO treatment.
Secondary outcome [4] 306838 0
30 day mortality post-ECMO intervention (up to 30 days post intervention) via retrospective chart audit.
Timepoint [4] 306838 0
30 days post ECMO treament

Eligibility
Key inclusion criteria
Participants receiving ECMO from January 2008- December 2012
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who did not receive ECMO treatment.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
2/01/2013
Actual
2/01/2013
Date of last participant enrolment
Anticipated
31/12/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
55
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2064 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 7760 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 288696 0
Self funded/Unfunded
Name [1] 288696 0
Country [1] 288696 0
Primary sponsor type
Other Collaborative groups
Name
Critical Care Research Group
Address
The Prince Charles Hospital.
MNHHS.
Rode Road,
Chermside.
QLD. 4032.
Country
Australia
Secondary sponsor category [1] 287401 0
None
Name [1] 287401 0
Address [1] 287401 0
Country [1] 287401 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290539 0
Research, Ethics and Governance Unit
Ethics committee address [1] 290539 0
Building 12.
The Prince Charles Hospital.
Rode Road,
Chermside. Qld. 4032.
Ethics committee country [1] 290539 0
Australia
Date submitted for ethics approval [1] 290539 0
Approval date [1] 290539 0
26/08/2011
Ethics approval number [1] 290539 0
11/QPCH/158

Summary
Brief summary
What are the rates of foot and lower limb complications following the use of extracorporeal membrane oxygenation (ECMO) in a major Australian tertiary hospital? Our null hypothesis is that the incidence of foot and lower limb complications in patients undergoing ECMO treatment are not different to those reported in the general inpatient population.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46146 0
Ms Helen V Martin
Address 46146 0
Podiatry.
Allied Health Department.
The Prince Charles Hospital.
Rode Road,
Chermside.
Qld. 4032.
Country 46146 0
Australia
Phone 46146 0
0061 7 3139 5565
Fax 46146 0
Email 46146 0
Helenvictoria.martin@health.qld.gov.au
Contact person for public queries
Name 46147 0
Ms Helen V Martin
Address 46147 0
Podiatry.
Allied Health Department.
The Prince Charles Hospital.
Rode Road,
Chermside.
Qld. 4032.
Country 46147 0
Australia
Phone 46147 0
0061 7 3139 5565
Fax 46147 0
Email 46147 0
Helenvictoria.martin@health.qld.gov.au
Contact person for scientific queries
Name 46148 0
Ms Helen V Martin
Address 46148 0
Podiatry.
Allied Health Department.
The Prince Charles Hospital.
Rode Road,
Chermside.
Qld. 4032.
Country 46148 0
Australia
Phone 46148 0
0061 7 3139 5565
Fax 46148 0
Email 46148 0
Helenvictoria.martin@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
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