Early Rehabilitation in Patients on Extracorporeal Membrane Oxygenation
- Conditions
- Extracorporeal Membrane Oxygenation Complication
- Interventions
- Other: Early Rehabilitation
- Registration Number
- NCT05003609
- Brief Summary
Critically ill patients who require extracorporeal membrane oxygenation (ECMO) are the sickest in the hospital. More patients are surviving but survivors have compromised functional recovery for months or years. This registry-embedded randomised trial aims to determine if early rehabilitation commenced within 72 hours of ECMO is feasible and improves muscle strength and functional status in patients compared to standard practice in a randomised controlled trial of 100 ICU patients. The effect of the intervention on mortality, health status, and function at 180 days will be evaluated, as well as cost-effectiveness. ECMO-Rehab trial is a registry embedded trial and will be utilising EXCEL data.
- Detailed Description
The trial is a 100-patient, multicentre, randomised, controlled, parallel-group, two-sided superiority trial that will randomly allocate eligible patients to early rehabilitation or standard care in a 1:1 ratio to determine if early rehabilitation of critically ill patients receiving ECMO reduces disability when compared with standard care. ECMO-Rehab trial is a registry embedded trial and will be utilising EXCEL data.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Patient is on ECMO and expected to remain on ECMO for at least 24 hours
- Patient is aged 18 years or older.
- Patient was functionally independent prior to the current admission.
- Patient is eligible for Medicare (Australian sites only).
- Patient has been receiving ECMO for more than 72 hours.
- Patient has been in ICU for more than 5 days.
- Patient has suspected or proven primary myopathic or neurological process associated with prolonged weakness or acute brain injury.
- Death is deemed imminent by the treating clinician.
- Patient has a documented medical diagnosis of cognitive impairment e.g. dementia.
- Patient was unable to mobilise prior to this admission.
- Patient is unable to communicate in local language.
- Patient is known to be pregnant.
- Patient is unlikely to be contactable for 6 months follow-up, e.g. overseas resident, incarcerated
- The treating clinician does not believe it is in the best interests of the patient to participate in the study
- Patient who has a bidirectional cannula in situ
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group Early Rehabilitation ECMO early rehabilitation is led by a senior physiotherapist who has specialised training in ECMO care and coordinates individualised early physical training from randomisation to day 28 in ICU and liaises with the patient through to hospital discharge. The early rehabilitation intervention involves physical activity, functional retraining, strengthening exercises and mobilisation based on a reproducible, physiological approach.
- Primary Outcome Measures
Name Time Method Modified Rankin Scale 180 days post randomisation The Modified Rankin Scale (mRS) is a 7-level ordered categorical scale capturing levels of patient disability and dependence, with scores ranging from 0 (no disability) to 6 (dead).
- Secondary Outcome Measures
Name Time Method Daily longitudinal ordinal organ support outcome to day 28 28 days post randomisation This includes outcomes on Dead; on ECMO; Off ECMO on IMV; Off IMV, in ICU; On acute hospital ward; Discharged alive
Health related quality of life (EQ5D-5L) at day 180 180 days post randomisation Level of severity 1 to 5 where 5 is the most severe
Muscle strength at day 14 (Medical Research Council Sum-Score) 14 days post randomisation Grade 0 to Grade 5 where Grade 5 is the best outcome
ECMO-free days to day 28 28 days post randomisation Organ failure free days to day 28 28 days post randomisation Delirium-free days to day 28 28 days post randomisation Activities of Daily Living (ADL) at hospital discharge up to day of hospital discharge, an average of 3 months Length of stay on ECMO, in ICU and in hospital up to day of stay on ECMO, ICU and hospital, an average of 3 months Mortality rate at ICU and hospital discharge, day 90 and day 180 up to 180 days post randomisation Instrumental activities of daily living at 180 days 180 days post randomisation Physical function measured with instrumental activities of daily living
Montreal Cognitive Assessment (MoCA-Blind) 180 days post randomisation Rapid screening instrument for mild cognitive dysfunction. Normal is equal or more than 18 points.
WHO Disability Assessment Schedule 2.0 at day 180 180 days post randomisation Scoring 10-48 are likely to have clinically significant disability.
Healthcare costs at day 180 180 days post randomisation Index hospital admission costs will be determined using clinical costing systems at each participating site. Post discharge costs will be determined using patient-level data linkage to determine long-term health care use (including readmission to hospital).
Cost-effectiveness at day 180 180 days post randomisation The primary cost-effectiveness analysis will be conducted from the Australian healthcare payer's perspective using an analytical time horizon of 180 days.
Trial Locations
- Locations (7)
Alfred Health
🇦🇺Melbourne, Victoria, Australia
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
St Vincent's Hospital Sydney
🇦🇺Darlinghurst, New South Wales, Australia
The Prince Charles Hospital
🇦🇺Chermside, Queensland, Australia
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
Fiona Stanley Hospital
🇦🇺Murdoch, Western Australia, Australia
Toronto General Hospital
🇨🇦Toronto, Canada