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Trial registered on ANZCTR


Registration number
ACTRN12614000337673
Ethics application status
Approved
Date submitted
17/03/2014
Date registered
28/03/2014
Date last updated
5/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Extracorporeal Membrane Oxygenation (ECMO) in adults: physical and mental health after hospitalisation.
Scientific title
Physical and mental health outcomes in critically ill adults treated with Extracorporeal Membrane Oxygenation (ECMO) in Intensive Care Units (ICUs).
Secondary ID [1] 284280 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Extracorporeal membrane oxygenation for lung and or heart failure 291417 0
Adult respiratory distress syndrome (ARDS) 291418 0
Acute lung failure
291509 0
Acute heart failure 291510 0
Condition category
Condition code
Physical Medicine / Rehabilitation 291780 291780 0 0
Other physical medicine / rehabilitation
Mental Health 291781 291781 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Prospective observational study 3,6,12 and 18 months post discharge using quantitative surveys to assess health related quality of life and mental health followed by a limited number of semi-structured qualitative interviews with patients and relatives.

Patients will be surveyed once at 3,6,12 and 18 months after discharge.
Relatives that participate in the interviews will be surveyed once at the time of the interview.


10 interviews with patients and 10 interviews with relatives for approximate 1,5 hours each will be conducted 12 months after discharge from the hospital. Patients and relatives will be interviewed once only. Interviews will cover the experience of ECMO treatment before and after discharge.
Intervention code [1] 288995 0
Not applicable
Comparator / control treatment
Patients treated with venous venous (VV) or venous arterial (VA) ECMO

Relatives
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291706 0
Health related quality of life, cognitive functioning; and depression, anxiety and post-traumatic stress disorder risk in patients 3 and 6 months after ECMO.

Short Form 36 Health survey (SF-36)
EQ-5D-5L survey (EQ-5D)
Hospital Anxiety and Depression Scale (HADS)
Telephone Interview for Cognitive Status (TICS)
Impact of Event Scale (revised) (IES-R)
Timepoint [1] 291706 0
Separate at 3 and 6 months after ECMO
Primary outcome [2] 291707 0
Health related quality of life, cognitive functioning; and depression, anxiety and post-traumatic stress disorder risk in patients 12 and 18 months after ECMO.

Short Form 36 Health survey (SF-36)
EQ-5D-5L survey (EQ-5D)
Hospital Anxiety and Depression Scale (HADS)
Telephone Interview for Cognitive Status (TICS)
Impact of Event Scale (revised) (IES-R)
Timepoint [2] 291707 0
Separate at 12 and 18 months after ECMO
Primary outcome [3] 291734 0
Patient's and relative's perception and experience with ECMO treatment

Exploration of themes that relate to patient's and relative's perception and experience with ECMO treatment and its impact on health outcomes via interviews using thematic analysis.

Interviews
Timepoint [3] 291734 0
12 months after ECMO
Secondary outcome [1] 307332 0
Differences in survey scores between VV and VA subgroups
Timepoint [1] 307332 0
Separate at 3,6,12 and 18 months after ECMO

Eligibility
Key inclusion criteria
Patients who are 18 years or older, admitted to ICU and treated with ECMO from 2013 – 2014/15.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients or relatives who do not speak English; cognitive / neurological impairments which would preclude completion of interviews or surveys; terminal conditions.

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Quantitative data: descriptive statistics

Qualitative data: thematic analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2207 0
The Alfred - Prahran
Recruitment postcode(s) [1] 7886 0
3004 - St Kilda Road Central

Funding & Sponsors
Funding source category [1] 288907 0
Other Collaborative groups
Name [1] 288907 0
Australian College of Critical Care Nurses
Address [1] 288907 0
Suite 1, 670 Canterbury Rd, Surrey Hills, Vic 3127
Country [1] 288907 0
Australia
Primary sponsor type
Individual
Name
Ralph Tramm
Address
Australian and New Zealand Intensive Care Research Centre
Department of Epidemiology and Preventive Medicine
School of Public Health and Preventive Medicine
Monash University
The Alfred Centre, Level 6
99 Commercial Road
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 287602 0
University
Name [1] 287602 0
Monash University,Department of Epidemiology and Preventive Medicine,School of Public Health and Preventive Medicine

Address [1] 287602 0
The Alfred Centre, Level 6
99 Commercial Road
Melbourne VIC 3004
Country [1] 287602 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290737 0
Alfred Ethics Committee
Ethics committee address [1] 290737 0
The Alfred
OFFICE OF ETHICS & RESEARCH GOVERNANCE
PO Box 315
Prahran VIC 3181
Ethics committee country [1] 290737 0
Australia
Date submitted for ethics approval [1] 290737 0
Approval date [1] 290737 0
06/02/2013
Ethics approval number [1] 290737 0
555/12

Summary
Brief summary
Prospective observational study 3,6,12 and 18 months post discharge using quantitative surveys to assess health related quality of life and mental health followed by a limited number of semi-structured qualitative interviews with patients and relatives.
Trial website
Trial related presentations / publications
A qualitative exploration of acute care and psychological distress experiences of ECMO survivors. Heart Lung. 2016 Feb 22. pii: S0147-9563(16)00011-X. doi: 10.1016/j.hrtlng.2016.01.010.
Public notes

Contacts
Principal investigator
Name 47010 0
Dr Carol Hodgson
Address 47010 0
Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine,Monash University

The Alfred Centre, Level 6
99 Commercial Road
Melbourne VIC 3004
Country 47010 0
Australia
Phone 47010 0
+61 3 990 30598
Fax 47010 0
Email 47010 0
carol.hodgson@monash.edu.au
Contact person for public queries
Name 47011 0
Mr Ralph Tramm
Address 47011 0
Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine,Monash University

The Alfred Centre, Level 6
99 Commercial Road
Melbourne VIC 3004
Country 47011 0
Australia
Phone 47011 0
+61 3 990 30932
Fax 47011 0
Email 47011 0
ralph.tramm@monash.edu.au
Contact person for scientific queries
Name 47012 0
Mr Ralph Tramm
Address 47012 0
Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine,Monash University

The Alfred Centre, Level 6
99 Commercial Road
Melbourne VIC 3004
Country 47012 0
Australia
Phone 47012 0
+61 3 990 30932
Fax 47012 0
Email 47012 0
ralph.tramm@monash.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary