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Critical IllnessECMO USSNCT02995811

Characterising Changes in Muscle Quantity and Quality in Patients Requiring ECMO Oxygen During Critical Illness

An observational study of Critical Illness and Intensive Care Units, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will identify the changes in different muscles of patients receiving Extracorporeal Membrane Oxygenation (ECMO) during critical illness and admission to Intensive Care Unit (ICU). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Observational Cohort
How many people
21 participants
Where
1 siteUnited Kingdom
Study dates
Nov 2016to 30 Jun 2019
Phase
Observational
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult critically ill patients admitted to the ICU with critical illness requiring ECMO

Who may be able to join

  • Adult, ≥18years
  • Requiring ECMO for management of severe respiratory failure
  • Likely to remain in the ICU for 10days

Who cannot join

  • Pregnancy
  • Neurological injury e.g. stroke, acquired brain injury
  • Trauma injury e.g. amputation, multiple fractures
  • Clinical presentation precluding ultrasound imaging of muscle at the time of assessment
  • Not expected to survive more than 24 hours

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Guys and St Thomas NHS Foundation

    London, SE1 7EH

Other trials in United Kingdom

About this study

Official title: Characterising Changes in Muscle Quantity and Quality in Patients Requiring Extracorporeal Membrane Oxygen During Critical Illness: 'ECMO-Ultrasound', An Observational Cohort Study

This study will identify the changes in different muscles of patients receiving Extracorporeal Membrane Oxygenation (ECMO) during critical illness and admission to Intensive Care Unit (ICU). The information will help guide development of treatments such as exercise that may help to reduce the amount of muscle wasting that can occur during critical illness.

Read the detailed description

Admission to the intensive care unit (ICU) with critical illness is typically associated with profound physical impairments including peripheral skeletal muscle wasting and dysfunction. These effects demonstrate a rapid onset from the point of ICU admission, affect those with higher illness acuity to greater levels, and contribute to the development of intensive care unit-acquired weakness (ICU-AW) defined as severe upper and lower limb muscle weakness.

Muscle structure has traditionally been evaluated using complex scanning approaches such as computed tomography or dual energy x-ray absorptiometry, however there are a number of caveats to their use in the clinical environment of critical care. Ionising radiation involved precludes their use in large populations, and especially for performance of sequential measurements. Whilst magnetic resonance imaging avoids this concern, practical limitations exist around scanning time and accessibility. In addition, all these imaging modalities require transfer out of the ICU environment, further restricting their application to acutely unwell, unstable patients. Finally, in addition to their expense, the nature of imaging using these approaches means that only a limited number of muscles may be assessed at any one time.

Ultrasound has emerged in recent years as a technique with significant clinical utility for assessing and monitoring the trajectory of change in muscle during acute critical illness. A range of parameters of muscle architecture and quality can be measured and data from the critical illness population is growing. Advantages of ultrasound include feasibility of bedside assessment, and that is it non-ionising, non-invasive and effort-independent with equipment is readily available in the critical care environment. Ultrasound imaging has robust clinimetric properties and predictive utility for morbidity and other clinical endpoints including mortality and hospital readmission.

A number of observational cohort studies have conducted sequential measurements of a range of respiratory and peripheral skeletal muscle groups during critical illness, characterising the decline in both muscle quantity and quality as a result of the acute insult. However no studies to date have included assessment of the abdominal muscles in critically ill patients necessary for core stability, trunk control and postural maintenance and therefore of significant clinical importance during the rehabilitation process.

In addition, whilst hypoxia has been found to be associated with greater muscle attenuation, no study has examined the relative changes in muscle in patients receiving extracorporeal membrane oxygenation (ECMO). ECMO is a ventilator support therapy primarily delivered to critically ill patients with severe respiratory failure where the hypoxic state is corrected.

The aim of this study is therefore to characterise sequential changes across respiratory, trunk and peripheral skeletal muscles in critically ill patients requiring ECMO.

Being tested
Observational Cohort
Medical subject headings
Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Observational CohortOther

    Ultrasound assessment of 4 muscles, activity monitoring, daily global peripheral skeletal muscle strength

Study groups in NCT02995811
Study groupRoleWhat they receive
Observational Cohort* On Days 1, 3, 7 and 10 of ICU admission, patients will undergo ultrasound assessment of the diaphragm, transverse and rectus abdominis, quadriceps rectus femoris, and tibialis anterior muscles. Imaging all four muscles together requires approximately 1 hour. * Physical activity monitoring: On Days 1-10 of ICU admission patients will wear an activity monitor. These devices use several inertial motion sensors to track the movement and acceleration of the limbs in horizontal and vertical directions. * Patients will also undergo daily assessment of global peripheral skeletal muscle strength assessed by the Medical Research Council Sum-score and global function measured by the Chelsea Critical Care Physical Assessment Scale
Receives: Other: Observational Cohort

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sequential changes in parameters of muscle architecture of the muscles in critically ill patients requiring ECMO by Ultrasound

    Measured: 10 days

  2. Sequential changes in quality of the muscles in critically ill patients requiring ECMO by Ultrasound

    Measured: 10 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2016 (estimated)
  2. Study startNov 2016
  3. Primary completion30 Jun 2019
  4. Study completion30 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02995811
Sponsor's protocol ID
208134
Acronym
ECMO USS
Status last verified
Apr 2018
First submitted
24 Nov 2016
Last updated
7 Feb 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No: No plan to share individual participant data

Questions about this trial

What is this clinical trial studying?

An observational study of Critical Illness and Intensive Care Units, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.

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 3 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 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. 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?

Sequential changes in parameters of muscle architecture of the muscles in critically ill patients requiring ECMO by Ultrasound (time frame: 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 7 Feb 2020.

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