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| Name | Class |
|---|---|
| Monash University | OTHER |
| National Health and Medical Research Council, Australia | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Active Comparator | 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. |
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| Control Group | No Intervention | The control group will receive standard care from nursing and physiotherapy staff not involved in the early, co-ordinated rehabilitation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Rehabilitation | Other | The intervention involves a progression of rehabilitation exercises with the objective of rehabilitating the patient at the highest level of exercise possible for the patient for the longest period of time that can be tolerated (up to 60 mins) at each session. The intervention will be administered 5 days per week (weekdays) while the patient remains in ICU, censored at 28 days after randomisation. |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Rankin Scale | 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). | 180 days post randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle strength at day 14 (Medical Research Council Sum-Score) | Grade 0 to Grade 5 where Grade 5 is the best outcome | 14 days post randomisation |
| ECMO-free days to day 28 | 28 days post randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Number of patients who suffered adverse events and serious adverse events such as fall, heart attack or new or increased oozing around cannulae during rehabilitation. | Up to 28 days post randomisation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carol Hodgson | ANZIC-RC, Monash University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Prince Alfred Hospital | Camperdown | New South Wales | Australia | |||
| St Vincent's Hospital Sydney |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32179935 | Background | ECMO-PT Study Investigators; International ECMO Network. Early mobilisation during extracorporeal membrane oxygenation was safe and feasible: a pilot randomised controlled trial. Intensive Care Med. 2020 May;46(5):1057-1059. doi: 10.1007/s00134-020-05994-8. Epub 2020 Mar 16. No abstract available. |
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1;1 allocation, stratified by site,
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Blinded outcome assessor - blinded / different therapist (strength) and central follow-up for blinded assessment of PROMs
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| 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 | Physical function measured with instrumental activities of daily living | 180 days post randomisation |
| Montreal Cognitive Assessment (MoCA-Blind) | Rapid screening instrument for mild cognitive dysfunction. Normal is equal or more than 18 points. | 180 days post randomisation |
| WHO Disability Assessment Schedule 2.0 at day 180 | Scoring 10-48 are likely to have clinically significant disability. | 180 days post randomisation |
| Health related quality of life (EQ5D-5L) at day 180 | Level of severity 1 to 5 where 5 is the most severe | 180 days post randomisation |
| Daily longitudinal ordinal organ support outcome to day 28 | This includes outcomes on Dead; on ECMO; Off ECMO on IMV; Off IMV, in ICU; On acute hospital ward; Discharged alive | 28 days post randomisation |
| Healthcare costs at day 180 | 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). | 180 days post randomisation |
| Cost-effectiveness at day 180 | The primary cost-effectiveness analysis will be conducted from the Australian healthcare payer's perspective using an analytical time horizon of 180 days. | 180 days post randomisation |
| Darlinghurst |
| New South Wales |
| 2010 |
| Australia |
| The Prince Charles Hospital | Chermside | Queensland | 4032 | Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | Australia |
| Alfred Health | Melbourne | Victoria | 3004 | Australia |
| Fiona Stanley Hospital | Murdoch | Western Australia | Australia |
| Toronto General Hospital | Toronto | Canada |