Critical IllnessULTRAMUSCLENCT03550222
Muscle Evaluation Using Ultrasound in the Critically Ill
An observational study of Critical Illness and ICU Acquired Weakness, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Critical illness is associated with ICU acquired weakness and diaphragmatic dysfunction. Ultrasound can evaluate the muscle mass non invasively and provides the ability for a muscle follow up during and after the ICU stay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, ICU Acquired Weakness
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jan 2018to 30 Dec 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: Critically ill patients with at least one organ failure and an estimated duration of ICU stay of 3 days or more
Who may be able to join
- Critically ill patients with at least one organ failure defined, organ failure being defined by a SOFA equal or above 3 for the organ, and an expected duration of ICU stay equal of above 3 days
Who cannot join
- Pregnancy, age below 18, absence of consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Muscle Evaluation Using Ultrasound in the Critically Ill : ULTRAMUSCLE Study
Critical illness is associated with ICU acquired weakness and diaphragmatic dysfunction.
Ultrasound can evaluate the muscle mass non invasively and provides the ability for a muscle follow up during and after the ICU stay. Magnetic stimulation of the phrenic nerves and the measure of the end expiratory tracheal pressure with an occlusion valve allows to evaluate the diaphragm force production in mechanically ventilated patients.
The aim of the present study is to constitute an image bank and to describe the muscle mass and function recovery in critically ill patients.
Read the detailed description
Critical illness is associated with ICU acquired weakness and diaphragmatic dysfunction.
Ultrasound can evaluate the muscle mass non invasively and provides the ability for a muscle follow up during and after the ICU stay. Magnetic stimulation of the phrenic nerves and the measure of the end expiratory tracheal pressure with an occlusion valve allows to evaluate the diaphragm force production in mechanically ventilated patients.
The aim of the present study is to constitute an image bank and to describe the mass and function recovery in critically ill patients.
Ultrasound and clinical data will be collected and analysed during the ICU stay.
- Conditions
- Critical Illness, ICU Acquired Weakness
- Keywords
- Diaphragmatic dysfunction, Mechanical Ventilation, ICU acquired weakness, Weaning, Skeletal muscles, Respiratory muscles
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound characteristics of the quadriceps
Changes in ultrasound characteristics of the quadriceps : cross sectional area of quadriceps (cm2)
Measured: Since admission at day 0 and measured repetitively by 48 hours untildischarge from ICU or date of death from any cause, whichever came first, assessed up to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start30 Jan 2018
- Primary completion1 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BORIS JUNG, MD, PhD, Study chair, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550222
- Sponsor's protocol ID
- RECHMPL17_0302
- Acronym
- ULTRAMUSCLE
- Status last verified
- Mar 2020
- First submitted
- 26 Sep 2017
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Publications
Aarab Y, Flatres A, Garnier F, Capdevila M, Raynaud F, Lacampagne A, Chapeau D, Klouche K, Etienne P, Jaber S, Molinari N, Gamon L, Matecki S, Jung B. Shear Wave Elastography, a New Tool for Diaphragmatic Qualitative Assessment: A Translational Study. Am J Respir Crit Care Med. 2021 Oct 1;204(7):797-806. doi: 10.1164/rccm.202011-4086OC.
PubMed 34255974Flatres A, Aarab Y, Nougaret S, Garnier F, Larcher R, Amalric M, Klouche K, Etienne P, Subra G, Jaber S, Molinari N, Matecki S, Jung B. Real-time shear wave ultrasound elastography: a new tool for the evaluation of diaphragm and limb muscle stiffness in critically ill patients. Crit Care. 2020 Feb 3;24(1):34. doi: 10.1186/s13054-020-2745-6.
PubMed 32014005
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Evaluation Using Ultrasound in the Critically Ill : ULTRAMUSCLE Study
- ClinicalTrials.gov ID
- NCT03550222
- Acronym / sponsor ID
- ULTRAMUSCLE / RECHMPL17_0302
- Conditions
- Critical Illness, ICU Acquired Weakness
- Keywords
- Diaphragmatic dysfunction, Mechanical Ventilation, ICU acquired weakness, Weaning, Skeletal muscles, Respiratory muscles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 8 Jun 2018 (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.
Critical illness is associated with ICU acquired weakness and diaphragmatic dysfunction.
Ultrasound can evaluate the muscle mass non invasively and provides the ability for a muscle follow up during and after the ICU stay. Magnetic stimulation of the phrenic nerves and the measure of the end expiratory tracheal pressure with an occlusion valve allows to evaluate the diaphragm force production in mechanically ventilated patients.
The aim of the present study is to constitute an image bank and to describe the muscle mass and function recovery in critically ill patients.
Detailed description
Critical illness is associated with ICU acquired weakness and diaphragmatic dysfunction.
Ultrasound can evaluate the muscle mass non invasively and provides the ability for a muscle follow up during and after the ICU stay. Magnetic stimulation of the phrenic nerves and the measure of the end expiratory tracheal pressure with an occlusion valve allows to evaluate the diaphragm force production in mechanically ventilated patients.
The aim of the present study is to constitute an image bank and to describe the mass and function recovery in critically ill patients.
Ultrasound and clinical data will be collected and analysed during the ICU stay.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients with at least one organ failure and an estimated duration of ICU stay of 3 days or more
Key inclusion criteria (1 listed)
- Critically ill patients with at least one organ failure defined, organ failure being defined by a SOFA equal or above 3 for the organ, and an expected duration of ICU stay equal of above 3 days
Key exclusion criteria (1 listed)
- Pregnancy, age below 18, absence of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ultrasound characteristics of the quadriceps
Time frame: Since admission at day 0 and measured repetitively by 48 hours untildischarge from ICU or date of death from any cause, whichever came first, assessed up to day 28
Changes in ultrasound characteristics of the quadriceps : cross sectional area of quadriceps (cm2)
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 10 Mar 2020.
- Derived from this study: PubMed 34255974Aarab Y, Flatres A, Garnier F, Capdevila M, Raynaud F, Lacampagne A, Chapeau D, Klouche K, Etienne P, Jaber S, Molinari N, Gamon L, Matecki S, Jung B. Shear Wave Elastography, a New Tool for Diaphragmatic Qualitative Assessment: A Translational Study. Am J Respir Crit Care Med. 2021 Oct 1;204(7):797-806. doi: 10.1164/rccm.202011-4086OC.
- Derived from this study: PubMed 32014005Flatres A, Aarab Y, Nougaret S, Garnier F, Larcher R, Amalric M, Klouche K, Etienne P, Subra G, Jaber S, Molinari N, Matecki S, Jung B. Real-time shear wave ultrasound elastography: a new tool for the evaluation of diaphragm and limb muscle stiffness in critically ill patients. Crit Care. 2020 Feb 3;24(1):34. doi: 10.1186/s13054-020-2745-6.
- Individual participant dataSharing planned: Undecided. NC
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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.
BORIS JUNG, MD, PhD study chair
University Hospital, Montpellier
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 ICU Acquired Weakness, run by University Hospital, Montpellier at 1 site in France.
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 1 inclusion and 1 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 10 Mar 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 France. 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?
Ultrasound characteristics of the quadriceps (time frame: Since admission at day 0 and measured repetitively by 48 hours untildischarge from ICU or date of death from any cause, whichever came first, assessed up to day 28). 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 NCT03550222, which also lists 2 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 10 Mar 2020.