Extracorporeal Membrane Oxygenation Physical Training

NCT03328767 | Completed

• 1 other identifier: ANZICRC/ECMO/001
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 5

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.

Conditions

Critically Ill, Mechanically Ventilated; Extracorporeal Membrane Oxygenation Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Time to first stand out of bed

  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

  During the first 7 days

• Strength at day 7 and 10

  Days 7 & 10

• Function (reported as ICU mobility scale) measured at days 7, 10 and 20

  Days 7, 10 & 20

• ICU and hospital length of stay

  Time from ICU admission to ICU and hospital discharge respectively censored at day 90

Study Arms (2)

Early activity and Mobilisation intervention

EXPERIMENTAL

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

Standard Care

NO 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.

Interventions

Early activity and Mobilisation intervention BEHAVIORAL

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

Early activity and Mobilisation intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Australian and New Zealand Intensive Care Research Centre: lead
• Toronto General Hospital: collaborator
• Monash University: collaborator
• The Alfred: collaborator
• Royal Prince Alfred Hospital, Sydney, Australia: collaborator
• The Prince Charles Hospital: collaborator
• St Vincent's Hospital, Sydney: collaborator

Study Sites (5)

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

St Vincent's Hospital

Sydney, New South Wales, 2010, Australia

Location

The Prince Charles Hospital

Chermside West, Queensland, 4032, Australia

Location

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (9)

• 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.

  PMID: 19446324 BACKGROUND

• 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.

  PMID: 23159157 BACKGROUND

• 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.

  PMID: 24373338 BACKGROUND

• 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.

  PMID: 27015233 BACKGROUND

• 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.

  PMID: 7129724 BACKGROUND

• 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.

  PMID: 22879441 BACKGROUND

• 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.

  PMID: 25475522 BACKGROUND

• 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.

  PMID: 26075426 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.

  PMID: 32179935 DERIVED

Related Links

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

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A 30 patient, multicentre, randomised, trial of early individualised physical training compared to standard care.

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: November 1, 2017
• Study Start: February 19, 2018
• Primary Completion: February 1, 2020
• Study Completion: May 1, 2020
• Last Updated: May 8, 2020

Record last verified: 2020-05

Locations

CA (1); AU (4)