Extracorporeal Membrane Oxygenation Physical Training

Extracorporeal Membrane Oxygenation Complication Clinical Trial

— ECMO-PT  

Official title:

A Pilot Randomised Controlled Trial in Extracorporeal Membrane Oxygenation Physical Training (ECMO-PT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03328767
• Other study ID #: ANZICRC/ECMO/001
• Status: Completed
• Phase: N/A
• Start date: February 19, 2018
• Est. completion date: May 1, 2020

Study information

• Verified date: May 2020
• Source: Australian and New Zealand Intensive Care Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill, Mechanically Ventilated
• Extracorporeal Membrane Oxygenation Complication

Intervention

Behavioral:
• Early activity and Mobilisation intervention
The early activity and mobilisation intervention is comprised of exercises based on a reproducible, physiological approach using both strength and functional activities

Locations

Country	Name	City	State
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	The Prince Charles Hospital	Chermside West	Queensland
Australia	Alfred Hospital	Melbourne	Victoria
Australia	St Vincent's Hospital	Sydney	New South Wales
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (7)

Lead Sponsor	Collaborator
Australian and New Zealand Intensive Care Research Centre	Monash University, Royal Prince Alfred Hospital, Sydney, Australia, St Vincent's Hospital, Sydney, The Alfred, The Prince Charles Hospital, Toronto General Hospital

Countries where clinical trial is conducted

Australia,  Canada, 

References & Publications (8)

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. — View 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. — View 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. — View 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. Erratum in: Heart Lung. 2014 Jul-Aug;43(4):388. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 days
Secondary	Time to first stand out of bed	Time to first stand out of bed (within the first 28 days)	Within the first 28 days
Secondary	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	During the first 7 days
Secondary	Strength at day 7 and 10	Strength at day 7 and 10	Days 7 & 10
Secondary	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	Days 7, 10 & 20
Secondary	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 from ICU admission to ICU and hospital discharge respectively censored at day 90
Secondary	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 from ICU admission to ICU and hospital discharge respectively censored at day 90

External Links

•   Early mobilisation during extracorporeal membrane oxygenation was safe and feasible: a pilot randomised controlled trial