Critically Ill, Mechanically VentilatedECMO-PTNCT03328767
Extracorporeal Membrane Oxygenation Physical Training
A study testing Early activity and Mobilisation intervention in people with Critically Ill, Mechanically Ventilated and Extracorporeal Membrane Oxygenation Complication, run by Australian and New Zealand Intensive Care Research Centre at 5 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Critically Ill, Mechanically Ventilated, Extracorporeal Membrane Oxygenation Complication
- What is being tested?
- Early activity and Mobilisation intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 19 Feb 2018to 1 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Australia4 sites
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
The Prince Charles Hospital
Chermside West, Queensland, 4032
Alfred Hospital
Melbourne, Victoria, 3004
St Vincent's Hospital
Sydney, New South Wales, 2010
About this study
Official title: A Pilot Randomised Controlled Trial in Extracorporeal Membrane Oxygenation Physical Training (ECMO-PT)
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.
Read the 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.
- Being tested
- Early activity and Mobilisation intervention
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early activity and Mobilisation interventionBehavioural
The early activity and mobilisation intervention is comprised of exercises based on a reproducible, physiological approach using both strength and functional activities
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Secondary outcomes (6)
Time to first stand out of bed
Time to first stand out of bed (within the first 28 days)
Measured: 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
Measured: During the first 7 days
Strength at day 7 and 10
Strength at day 7 and 10
Measured: 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
Measured: 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)
Measured: 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)
Measured: Time from ICU admission to ICU and hospital discharge respectively censored at day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start19 Feb 2018
- Primary completion1 Feb 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Critically Ill, Mechanically VentilatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A 30 patient, multicentre, randomised, trial of early individualised physical training compared to standard care.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Australian and New Zealand Intensive Care Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Toronto General Hospital, Monash University, The Alfred, Royal Prince Alfred Hospital, Sydney, Australia, The Prince Charles Hospital, St Vincent's Hospital, Sydney
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328767
- Sponsor's protocol ID
- ANZICRC/ECMO/001
- Acronym
- ECMO-PT
- Status last verified
- May 2020
- First submitted
- 24 Oct 2017
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Yes
Publications
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.
PubMed 19446324Craig 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.
PubMed 23159157Hodgson 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.
PubMed 24373338Tipping 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.
PubMed 27015233Borg 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.
PubMed 7129724Berney 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.
PubMed 22879441Hodgson 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.
PubMed 25475522Puthucheary 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.
PubMed 26075426ECMO-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.
PubMed 32179935
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomised Controlled Trial in Extracorporeal Membrane Oxygenation Physical Training (ECMO-PT)
- ClinicalTrials.gov ID
- NCT03328767
- Acronym / sponsor ID
- ECMO-PT / ANZICRC/ECMO/001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Australian and New Zealand Intensive Care Research CentreUniversity, hospital or other
- Collaborators
- Toronto General Hospital, Monash University, The Alfred, Royal Prince Alfred Hospital, Sydney, Australia, The Prince Charles Hospital, St Vincent's Hospital, Sydney
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 1 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A 30 patient, multicentre, randomised, trial of early individualised physical training compared to standard care.
| Arm | Type | Receives |
|---|---|---|
| Early activity and Mobilisation intervention | Experimental | Behavioral: Early activity and Mobilisation interventionPatients 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). |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early activity and Mobilisation interventionThe early activity and mobilisation intervention is comprised of exercises based on a reproducible, physiological approach using both strength and functional activities | Behavioural | Early activity and Mobilisation intervention |
Primary outcome
Feasibility of delivering the intervention in the first 7 days after randomisation and the separation between the groups
Time frame: 7 days
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.
6 secondary outcomes
Time to first stand out of bed
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
Time frame: During the first 7 days
Strength at day 7 and 10
Time frame: Days 7 & 10
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
Time frame: Time from ICU admission to ICU and hospital discharge respectively censored at day 90
ICU and in-hospital mortality
Time frame: Time from ICU admission to ICU and hospital discharge respectively censored at day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
- Background: PubMed 19446324Schweickert 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.
- Background: PubMed 23159157Craig 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.
- Background: PubMed 24373338Hodgson 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.
- Background: PubMed 27015233Tipping 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.
- Background: PubMed 7129724Borg 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.
- Background: PubMed 22879441Berney 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.
- Background: PubMed 25475522Hodgson 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.
- Background: PubMed 26075426Puthucheary 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.
- Derived from this study: PubMed 32179935ECMO-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.
- Early mobilisation during extracorporeal membrane oxygenation was safe and feasible: a pilot randomised controlled trialLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early activity and Mobilisation intervention in people with Critically Ill, Mechanically Ventilated and Extracorporeal Membrane Oxygenation Complication, run by Australian and New Zealand Intensive Care Research Centre at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of delivering the intervention in the first 7 days after randomisation and the separation between the groups (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03328767, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2020.