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Completed

NCT Number: NCT03328767

Extracorporeal Membrane Oxygenation Physical Training

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Time to first stand out of bed

    Time frame: Within the first 28 days

    Time to first stand out of bed (within the first 28 days)

  2. 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

    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

  3. Strength at day 7 and 10

    Time frame: Days 7 & 10

    Strength at day 7 and 10

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

    Time frame: Days 7, 10 & 20

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

  5. ICU and hospital length of stay

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

    ICU and hospital length of stay (time from ICU admission to ICU and hospital discharge respectively censored at day 90)

  6. ICU and in-hospital mortality

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

    ICU and in-hospital mortality (time from ICU admission to ICU and hospital discharge respectively censored at day 90)

Sponsors and collaborators

Lead sponsor

Australian and New Zealand Intensive Care Research Centre

Other

Collaborators

  • Monash University
  • Royal Prince Alfred Hospital, Sydney, Australia
  • St Vincent's Hospital, Sydney
  • The Alfred
  • The Prince Charles Hospital
  • Toronto General Hospital

Registry information

Official study title

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

Acronym: ECMO-PT

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 1, 2017
Registry last updated
May 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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