Clinical trial NCT03328767: Extracorporeal Membrane Oxygenation Physical Training
Official title: A Pilot Randomised Controlled Trial in Extracorporeal Membrane Oxygenation Physical Training (ECMO-PT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critically Ill, Mechanically Ventilated
Extracorporeal Membrane Oxygenation Complication
Lead sponsor: Australian and New Zealand Intensive Care Research Centre
Sponsor class: OTHER
Collaborators: name: Toronto General Hospital
name: Monash University
name: The Alfred
name: Royal Prince Alfred Hospital, Sydney, Australia
name: The Prince Charles Hospital
name: St Vincent's Hospital, Sydney
First posted: 2017-11-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A 30 patient, multicentre, randomised, trial of early individualised physical training compared to standard care.
Primary purpose: TREATMENT

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 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* adults ≥ 18 years of age
* were physically independent prior to the current admission;
* receiving ECMO (veno-arterial or veno-venous) for at least 24 hours;
* clinician in charge of patient care has no objection to randomisation

Exclusion Criteria:

* have been in ICU \> 5 days prior to the commencement of ECMO;
* have received ECMO for more than 48 hours;
* in the opinion of the treating clinician, is not expected to recover in 90 days (e.g. intracerebral haemorrhage);
* whom death is expected within 24 hours;
* are unable to communicate in English

Primary outcomes:
measure: Feasibility of delivering the intervention in the first 7 days after randomisation and the separation between the groups
timeFrame: 7 days
Secondary outcomes:
measure: Time to first stand out of bed
timeFrame: Within the first 28 days
measure: 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
timeFrame: During the first 7 days
measure: Strength at day 7 and 10
timeFrame: Days 7 & 10
measure: Function (reported as ICU mobility scale) measured at days 7, 10 and 20
timeFrame: Days 7, 10 & 20
measure: ICU and hospital length of stay
timeFrame: Time from ICU admission to ICU and hospital discharge respectively censored at day 90
measure: ICU and in-hospital mortality
timeFrame: Time from ICU admission to ICU and hospital discharge respectively censored at day 90
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Sydney
country: Australia
facility: St Vincent's Hospital
state: New South Wales
city: Chermside West
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
References:
citation: Schweickert WD, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook CL, Spears L, Miller M, Franczyk M, Deprizio D, Schmidt GA, Bowman A, Barr R, McCallister KE, Hall JB, Kress JP. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet. 2009 May 30;373(9678):1874-82. doi: 10.1016/S0140-6736(09)60658-9. Epub 2009 May 14.
citation: Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. Int J Nurs Stud. 2013 May;50(5):587-92. doi: 10.1016/j.ijnurstu.2012.09.010. Epub 2012 Nov 15. No abstract available.
citation: Hodgson C, Needham D, Haines K, Bailey M, Ward A, Harrold M, Young P, Zanni J, Buhr H, Higgins A, Presneill J, Berney S. Feasibility and inter-rater reliability of the ICU Mobility Scale. Heart Lung. 2014 Jan-Feb;43(1):19-24. doi: 10.1016/j.hrtlng.2013.11.003. Epub 2013 Nov 19.
citation: Tipping CJ, Bailey MJ, Bellomo R, Berney S, Buhr H, Denehy L, Harrold M, Holland A, Higgins AM, Iwashyna TJ, Needham D, Presneill J, Saxena M, Skinner EH, Webb S, Young P, Zanni J, Hodgson CL. The ICU Mobility Scale Has Construct and Predictive Validity and Is Responsive. A Multicenter Observational Study. Ann Am Thorac Soc. 2016 Jun;13(6):887-93. doi: 10.1513/AnnalsATS.201510-717OC.
citation: Borg G. Ratings of perceived exertion and heart rates during short-term cycle exercise and their use in a new cycling strength test. Int J Sports Med. 1982 Aug;3(3):153-8. doi: 10.1055/s-2008-1026080.
citation: Berney S, Haines K, Skinner EH, Denehy L. Safety and feasibility of an exercise prescription approach to rehabilitation across the continuum of care for survivors of critical illness. Phys Ther. 2012 Dec;92(12):1524-35. doi: 10.2522/ptj.20110406. Epub 2012 Aug 9.
citation: Hodgson CL, Stiller K, Needham DM, Tipping CJ, Harrold M, Baldwin CE, Bradley S, Berney S, Caruana LR, Elliott D, Green M, Haines K, Higgins AM, Kaukonen KM, Leditschke IA, Nickels MR, Paratz J, Patman S, Skinner EH, Young PJ, Zanni JM, Denehy L, Webb SA. Expert consensus and recommendations on safety criteria for active mobilization of mechanically ventilated critically ill adults. Crit Care. 2014 Dec 4;18(6):658. doi: 10.1186/s13054-014-0658-y.
citation: Puthucheary ZA, Denehy L. Exercise Interventions in Critical Illness Survivors: Understanding Inclusion and Stratification Criteria. Am J Respir Crit Care Med. 2015 Jun 15;191(12):1464-7. doi: 10.1164/rccm.201410-1907LE. No abstract available.
citation: 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.