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.
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
- Conditions the study is for
- Critical Illness, Intensive Care Units, Extracorporeal Membrane Oxygenation
- 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.
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 group | Role | What 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.
Sequential changes in parameters of muscle architecture of the muscles in critically ill patients requiring ECMO by Ultrasound
Measured: 10 days
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.
- First posted16 Dec 2016 (estimated)
- Study startNov 2016
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Euro-ELSO
- Responsible party
- Sponsor
- Investigators
- Nick Barrett, Study chair, Guy's and St Thomas' NHS Foundation Trust
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterising Changes in Muscle Quantity and Quality in Patients Requiring Extracorporeal Membrane Oxygen During Critical Illness: 'ECMO-Ultrasound', An Observational Cohort Study
- ClinicalTrials.gov ID
- NCT02995811
- Acronym / sponsor ID
- ECMO USS / 208134
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Euro-ELSO
- Study start
- Nov 2016
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 16 Dec 2016 (estimated)
- 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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Cohort | – | Other: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult critically ill patients admitted to the ICU with critical illness requiring ECMO
Key inclusion criteria (3 listed)
- Adult, ≥18years
- Requiring ECMO for management of severe respiratory failure
- Likely to remain in the ICU for 10days
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Observational CohortUltrasound assessment of 4 muscles, activity monitoring, daily global peripheral skeletal muscle strength | Other | Observational Cohort |
Primary outcome
Sequential changes in parameters of muscle architecture of the muscles in critically ill patients requiring ECMO by Ultrasound
Time frame: 10 days
Sequential changes in quality of the muscles in critically ill patients requiring ECMO by Ultrasound
Time frame: 10 Days
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 7 Feb 2020.
- Individual participant dataSharing planned: No. No plan to share individual participant data
Related trials for Critical Illness
Not yet recruitingObservational study
Ultrasound-Calibrated Pulse Contour Cardiac Output Monitoring: Value and Accuracy in Hemodynamic Care
Sepsis, Circulatory Instability
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Soap-and-Water Bed Bath Versus Disposable Wipe Bath in the Same ICU Patients
Critical Illness, Pain
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
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.
Nick Barrett study chair
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
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.