An interventional study of Early activity and Mobilisation intervention in Critically Ill, Mechanically Ventilated and Extracorporeal Membrane Oxygenation Complication, sponsored by Australian and New Zealand Intensive Care Research Centre. Completed at 5 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-05-08.
Sponsored by Australian and New Zealand Intensive Care Research Centre · Not applicable, Interventional, and Treatment
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 trial aims to determine if early, physical training commenced within 48 hours of ECMO is feasible and improves muscle strength and functional status in patients compared to standard practice in a randomised controlled trial of 30 ICU patients.
The use of extracorporeal membrane oxygenation (ECMO) has expanded dramatically in Australia and globally. While life-saving in the short-term, it is typically associated with prolonged immobility and inflammation, which contributes to severe muscle weakness and wasting. Standard care delivers minimal physical training while patients remain on ECMO because standard care prioritises concerns about catheter dislodgement and cardio-respiratory strain. However, in other intensive care unit (ICU) conditions, techniques have been developed to allow early physical training in patients previously thought too unstable to be exercised, with important patient-centred and long-term cost-saving benefits. Our preliminary work shows that early individualised physical training is safe in ICU patients. A multicentre pilot study to establish feasibility in ECMO patients is urgently needed.
The primary aim is to test the hypothesis that early, individualised, physical training (commenced within first 48 hours of ECMO) is feasible and improves functional recovery (the highest level of activity and duration). This has previously been reported to be associated with improved independent function at hospital discharge and discharge to home.1 The secondary aims are to test the hypothesis that early individualised physical training is (i) safe; (ii) improves muscle strength at day 7 and 10 and 20; and (iii) improves functional status (IMS) at day 7, 10 and 20 in ECMO patients relative to standard care.
We are also aiming to describe the acute physiological effects of early physical training (commenced within 48hours of ECMO initiation) Respiratory and haemodynamic parameters, along with ECMO settings, will be recorded 30 minutes prior to each physical training session, during the session and 30 minutes post the training session. In addition, the range of values (min to max) for these parameters will be recorded for each 24hour period over the 7 days.
1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.
This study's enrollment of 20 is below the median of 90 across 926 interventional studies indexed under Critical Illness.
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Exclusion Criteria:
Patients will be randomised within 48 hrs of commencing ECMO. Patients unable to initially receive active physical training will receive passive physical training for a minimum of 20 minutes and a maximum of one hour per day to maintain joint and muscle activity until active physical training is commenced. The intervention involves a progression of 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 minutes) at each session, based on our published ICU mobility scale now used internationally in ICU trials. This is performed with or without IMV (including both endotracheal tubes or tracheostomies).
Behavioral: Early activity and Mobilisation intervention
The control group will receive standard care from physiotherapy staff not involved in delivering the intervention. We have previously established that standard care in Australia for a patient receiving prolonged IMV (control group intervention) frequently involves no active exercise out of bed.
The early activity and mobilisation intervention is comprised of exercises based on a reproducible, physiological approach using both strength and functional activities
Feasibility of delivering the intervention in the first 7 days after randomisation and the separation between the groups
Feasibility of delivering the intervention in the first 7 days after randomisation and the separation between the groups using the ICU mobility scale to report the highest level of activity. It is reported as median (IQR) over 7 days.
Time frame: 7 days
Time to first stand out of bed
Time to first stand out of bed (within the first 28 days)
Time frame: Within the first 28 days
Incidence of Treatment-Emergent Adverse Events, Safety events (including decannulation of ventilator or ECMO cannula, fall to the floor during mobilization, desaturation SpO2 < 85%) at anytime during the first 7 days
Incidence of Treatment-Emergent Adverse Events, Safety events (including decannulation of ventilator or ECMO cannula, fall to the floor during mobilization, desaturation SpO2 \< 85%) at anytime during the first 7 days
Time frame: During the first 7 days
Strength at day 7 and 10
Strength at day 7 and 10
Time frame: Days 7 & 10
Function (reported as ICU mobility scale) measured at days 7, 10 and 20
Function (reported as ICU mobility scale) measured at days 7, 10 and 20
Time frame: Days 7, 10 & 20
ICU and hospital length of stay
ICU and hospital length of stay (time from ICU admission to ICU and hospital discharge respectively censored at day 90)
Time frame: Time from ICU admission to ICU and hospital discharge respectively censored at day 90
ICU and in-hospital mortality
ICU and in-hospital mortality (time from ICU admission to ICU and hospital discharge respectively censored at day 90)
Time frame: Time from ICU admission to ICU and hospital discharge respectively censored at day 90
Plan to share: Undecided — Yes
Ran from Feb 2018 to primary completion in Feb 2020, 23 months.
Of 400 non-industry interventional studies with no phase under Critical Illness, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 40. This study's 23 months is close to that.
Counting every sponsor, half of 404 studies reached it within 21 months; a quarter within 12 and three quarters within 40.
Critical Illness covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Australian and New Zealand Intensive Care Research Centre