Early Rehabilitation in Patients on Extracorporeal Membrane Oxygenation (ECMO-Rehab)

Australian and New Zealand Intensive Care Research Centre

Status: Active, not recruiting

Conditions: Extracorporeal Membrane Oxygenation Complication

Treatments: Other: Early Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT05003609

ANZIC-RC/ECMO-REHAB/001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient is on ECMO and expected to remain on ECMO for at least 24 hours
2. Patient is aged 18 years or older.
3. Patient was functionally independent prior to the current admission.
4. Patient is eligible for Medicare (Australian sites only).

Exclusion criteria

1. Patient has been receiving ECMO for more than 72 hours.
2. Patient has been in ICU for more than 5 days.
3. Patient has suspected or proven primary myopathic or neurological process associated with prolonged weakness or acute brain injury.
4. Death is deemed imminent by the treating clinician.
5. Patient has a documented medical diagnosis of cognitive impairment e.g. dementia.
6. Patient was unable to mobilise prior to this admission.
7. Patient is unable to communicate in local language.
8. Patient is known to be pregnant.
9. Patient is unlikely to be contactable for 6 months follow-up, e.g. overseas resident, incarcerated
10. The treating clinician does not believe it is in the best interests of the patient to participate in the study
11. Patient who has a bidirectional cannula in situ

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

100 participants in 2 patient groups

Intervention Group

Active Comparator group

Description:

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.

Treatment:

Other: Early Rehabilitation

Control Group

No Intervention group

Description:

The control group will receive standard care from nursing and physiotherapy staff not involved in the early, co-ordinated rehabilitation.