AmyotrophiaFIBERNCT03735693
Diagnosis of Muscular Weakness Syndrome After a Stay in Intensive Care : Measurement by Ultrasound
An observational study of Amyotrophia and Weakness, Muscle, run by Association Pro-arte at 1 site in France.
Trial summary
The objective is to diagnose earlier and more precisely the occurrence of a weakness neuromuscular syndrome at the end of intensive care, or within 28 days if the stay is longer than 28 days. The amyotrophy has been shown to be proportional to muscle strength in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amyotrophia, Weakness, Muscle
- What is being tested?
- Ulstrasound
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 14 Sep 2018to 2 Feb 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study concerns people admitted in intensive care unit, intubated and ventilated.
Who may be able to join
- Predictable mechanical ventilation time of at least 48 hours
- Patient intubated for less than 48 hours
- Social security
- Not opposing, or whose family does not object to this research
Who cannot join
- Neuromuscular pathology
- Amputation of one of the limbs
- Central or peripheral neurological impairment impacting the realization of the MRC score
- Orthopaedic trauma of the limbs or the pelvis preventing the achievement of an MRC score at the exit of resuscitation or by default at J28
- Subject in exclusion period of another study
- Persons referred to in Articles L1121-5 to L1121-8 of the CSP
Trial locations and contacts
1 site in 1 country.
About this study
The objective is to diagnose earlier and more precisely the occurrence of a weakness neuromuscular syndrome at the end of intensive care, or within 28 days if the stay is longer than 28 days. The amyotrophy has been shown to be proportional to muscle strength in healthy subjects. The amyotrophy can be reliably evaluated by measuring the cross-sectional area of the right femoral muscle. The hypothesis is that amyotrophy measured by muscle ultrasound can allow an early and reliable diagnosis of neuromuscular weakness syndrome (NMWS), even though the measurement of the MRC score (the Gold Standard), has shown its limitations in intensive care in terms of reliability and delayed diagnosis.
Moreover, this syndrome is associated with a loss of functionality and a deterioration of long-term quality of life. One of the objectives is thus to determine if the muscular ultrasound allows a prediction of the occurrence of these alterations far from the intensive care.
Read more
Early rehabilitation has shown a benefit on mortality, duration of stay, mechanical ventilation and on functional alteration after intensive care. This is why an earlier and more precise means of diagnostic of this pathology is searched.
The target population is therefore patients from 18 to 80 years hospitalized in intensive care for prolonged stay (> 5 days), and prolonged ventilation (> 48H).
Read the detailed description
Neuromuscular weakness syndrome post intensive care is a generalized muscular weakness with amyotrophy caused by the stay in the intensive care unit. This pathology is frequent, under diagnosed, increases the length of stay and mortality in intensive care and alters the functional status in the long term (mobility, autonomy, cognitive abilities). The gold standard is the MRC score. It must be under 48/60. But this means of diagnostic is unreliable and tardive (problem of voluntary cooperation, confusion, sedation).
This study allows the earlier diagnosis of neuromuscular weakness syndrome, by muscular ultrasound. Ultrasound of the right femoral muscle allows evaluation of the amyotrophy, which is related to the maximum muscular strength.
The early rehabilitation enable improved prognosis. This is an observational, prospective, single-center, blinded, observational study.
The objective is to determine the day of ultrasound examination with the highest diagnostic performance to predict with a maximum of specificity the occurrence of post-intensive care neuromuscular weakness syndrome, defined by an MRC score <48/60 at the end of intensive care or if the duration of stay exceeds 28 days on the 28th day of hospitalization in intensive care unit.
- Conditions
- Amyotrophia, Weakness, Muscle
- Being tested
- Ulstrasound
- Keywords
- ultrasound, intensive care
- Medical subject headings
- Muscular Atrophy, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UlstrasoundDiagnostic test
measurement of right femoral cross-section
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the day of ultrasound examination having the highest diagnostic performance to predict with a maximum of specificity the occurrence of a neuromuscular weakness syndrome post-intensive care unit
Two-to-two comparison of the AUCs of 3 ROC curves corresponding to 3 measurements by ultrasound of decreasing muscles between J1-J5, J1-J7 and J1-J10
Measured: through study completion, an average of 1 year
Secondary outcomes (22)
Determination of the perfect threshold of muscular decrease allowing the prediction with the maximum of specificity of a post-intensive care neuromuscular weakness syndrome
Look for the 3 ROC curves corresponding to 3 measurements of ultrasound muscle reduction between J1-J5, J1-J7 and J1-J10, the optimal threshold for measuring the cross sectional area of the right femoral muscle
Measured: through study completion, an average of 1 year
comparison of the persistence of neuromuscular weakness into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
MRC score : Medical Research Council (muscular testing), from 0 to 5 for each muscular group, and from 0 (complete tetraplegia) to 60 (normal muscular strength) for the total. The 6 subscales are summed.
Measured: 3 months after discharge from hospital
comparison of functional alteration into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
SF12 score (short form - 12) : quality of life questionnaire, range from 0 to 100. Each standardized data are summed
Measured: 3 months after discharge from hospital
comparison of functional alteration into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
walk test of 6 minuts (Detect abnormalities of gas exchange during exercise)
Measured: 3 months after discharge from hospital
comparison of functional alteration into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
Get up and Go test (evaluates sit-stand transfers, walking, and patient directional changes) : ranges from 1 (no instability) to 5 (very abnormal)
Measured: 3 months after discharge from hospital
comparison of functional alteration into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
ADL score (autonomy scale) : ranging from 0 (dependant) to 6 (independent)
Measured: 3 months after discharge from hospital
comparison of functional alteration into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
the Karnofsky index (description of the general condition of the patient) : from 0% (dead) to 100% (normal state)
Measured: 3 months after discharge from hospital
comparison of mortality at discharge of intensive care unit into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
mortality rate
Measured: during hospitalization in intensive care, at hospital discharge, and 3 months after hospital discharge
Comparison of length of stay in intensive care unit and hospital into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
calculation of the length of stay
Measured: through study completion, an average of 1 year
Comparison of duration of mechanical ventilation, Optiflow, NIV, and number of days without ventilation into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
calculation of the duration of ventilation and no-ventilation
Measured: through study completion, an average of 1 year
Comparison of malnutrition into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
Variation of albuminemia
Measured: at intensive care discharge, within a limit of 28 days, at 3 months
Comparison of malnutrition into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
Variation of pre-albuminemia
Measured: at intensive care discharge, within a limit of 28 days, at 3 months
Comparison of malnutrition into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
Variation of creatinine
Measured: at intensive care discharge, within a limit of 28 days, at 3 months
Comparison of malnutrition into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
Variation of weight
Measured: at intensive care discharge, within a limit of 28 days, at 3 months
Comparison of malnutrition into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
Variation of arm circumference
Measured: at intensive care discharge, within a limit of 28 days, at 3 months
Comparison of malnutrition into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
Variation NUTRIC score ; ranging from 0 (low malnutrition risk) to 10 (the most likely to benefit from aggressive nutrition therapy).
Measured: at intensive care discharge, within a limit of 28 days, at 3 months
Comparison of calorie intake into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
Daily calorie intake
Measured: through study completion, an average of 1 year
Comparison of drug intake into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
the number of days with sedation in intensive care
Measured: through study completion, an average of 1 year
Comparison of drug intake into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
the number of days with curarization in intensive care
Measured: through study completion, an average of 1 year
Comparison of drug intake into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
the dose of opioids in intensive care
Measured: through study completion, an average of 1 year
Comparison of drug intake into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
the number of days with sedation and curarization in intensive care, the dose of opioids and the administration of corticosteroids in intensive care
Measured: During stay in intensive care
Comparison of drug intake into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
the administration of corticosteroids in intensive care
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start14 Sep 2018
- Primary completion14 Dec 2021
- Study completion2 Feb 2022
Why it stopped: missing data, little recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmyotrophiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association Pro-arte
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735693
- Sponsor's protocol ID
- 3-2018-FIBER
- Acronym
- FIBER
- Status last verified
- Nov 2022
- First submitted
- 30 Oct 2018
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Muscular Weakness Syndrome After a Stay in Intensive Care : Measurement by Ultrasound
- ClinicalTrials.gov ID
- NCT03735693
- Acronym / sponsor ID
- FIBER / 3-2018-FIBER
- Conditions
- Amyotrophia, Weakness, Muscle
- Keywords
- ultrasound, intensive care
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: missing data, little recruitment
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Association Pro-arteUniversity, hospital or other
- Study start
- 14 Sep 2018 (actual)
- Primary completion
- 14 Dec 2021 (actual)
- Study completion
- 2 Feb 2022 (actual)
- First posted
- 8 Nov 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.
The objective is to diagnose earlier and more precisely the occurrence of a weakness neuromuscular syndrome at the end of intensive care, or within 28 days if the stay is longer than 28 days. The amyotrophy has been shown to be proportional to muscle strength in healthy subjects. The amyotrophy can be reliably evaluated by measuring the cross-sectional area of the right femoral muscle. The hypothesis is that amyotrophy measured by muscle ultrasound can allow an early and reliable diagnosis of neuromuscular weakness syndrome (NMWS), even though the measurement of the MRC score (the Gold Standard), has shown its limitations in intensive care in terms of reliability and delayed diagnosis.
Moreover, this syndrome is associated with a loss of functionality and a deterioration of long-term quality of life. One of the objectives is thus to determine if the muscular ultrasound allows a prediction of the occurrence of these alterations far from the intensive care.
Early rehabilitation has shown a benefit on mortality, duration of stay, mechanical ventilation and on functional alteration after intensive care. This is why an earlier and more precise means of diagnostic of this pathology is searched.
The target population is therefore patients from 18 to 80 years hospitalized in intensive care for prolonged stay (> 5 days), and prolonged ventilation (> 48H).
Detailed description
Neuromuscular weakness syndrome post intensive care is a generalized muscular weakness with amyotrophy caused by the stay in the intensive care unit. This pathology is frequent, under diagnosed, increases the length of stay and mortality in intensive care and alters the functional status in the long term (mobility, autonomy, cognitive abilities). The gold standard is the MRC score. It must be under 48/60. But this means of diagnostic is unreliable and tardive (problem of voluntary cooperation, confusion, sedation).
This study allows the earlier diagnosis of neuromuscular weakness syndrome, by muscular ultrasound. Ultrasound of the right femoral muscle allows evaluation of the amyotrophy, which is related to the maximum muscular strength.
The early rehabilitation enable improved prognosis. This is an observational, prospective, single-center, blinded, observational study.
The objective is to determine the day of ultrasound examination with the highest diagnostic performance to predict with a maximum of specificity the occurrence of post-intensive care neuromuscular weakness syndrome, defined by an MRC score <48/60 at the end of intensive care or if the duration of stay exceeds 28 days on the 28th day of hospitalization in intensive care unit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study concerns people admitted in intensive care unit, intubated and ventilated.
Key inclusion criteria (4 listed)
- Predictable mechanical ventilation time of at least 48 hours
- Patient intubated for less than 48 hours
- Social security
- Not opposing, or whose family does not object to this research
Key exclusion criteria (6 listed)
- Neuromuscular pathology
- Amputation of one of the limbs
- Central or peripheral neurological impairment impacting the realization of the MRC score
- Orthopaedic trauma of the limbs or the pelvis preventing the achievement of an MRC score at the exit of resuscitation or by default at J28
- Subject in exclusion period of another study
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 |
|---|---|---|
| Ulstrasoundmeasurement of right femoral cross-section | Diagnostic test | – |
Primary outcome
Determination of the day of ultrasound examination having the highest diagnostic performance to predict with a maximum of specificity the occurrence of a neuromuscular weakness syndrome post-intensive care unit
Time frame: through study completion, an average of 1 year
Two-to-two comparison of the AUCs of 3 ROC curves corresponding to 3 measurements by ultrasound of decreasing muscles between J1-J5, J1-J7 and J1-J10
22 secondary outcomes
Determination of the perfect threshold of muscular decrease allowing the prediction with the maximum of specificity of a post-intensive care neuromuscular weakness syndrome
Time frame: through study completion, an average of 1 year
comparison of the persistence of neuromuscular weakness into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
Time frame: 3 months after discharge from hospital
comparison of functional alteration into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
Time frame: 3 months after discharge from hospital
comparison of functional alteration into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
Time frame: 3 months after discharge from hospital
comparison of functional alteration into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
Time frame: 3 months after discharge from hospital
comparison of functional alteration into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
Time frame: 3 months after discharge from hospital
comparison of functional alteration into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
Time frame: 3 months after discharge from hospital
comparison of mortality at discharge of intensive care unit into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
Time frame: during hospitalization in intensive care, at hospital discharge, and 3 months after hospital discharge
Comparison of length of stay in intensive care unit and hospital into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
Time frame: through study completion, an average of 1 year
Comparison of duration of mechanical ventilation, Optiflow, NIV, and number of days without ventilation into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
Time frame: through study completion, an average of 1 year
Comparison of malnutrition into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
Time frame: at intensive care discharge, within a limit of 28 days, at 3 months
Comparison of malnutrition into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
Time frame: at intensive care discharge, within a limit of 28 days, at 3 months
Comparison of malnutrition into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
Time frame: at intensive care discharge, within a limit of 28 days, at 3 months
Comparison of malnutrition into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
Time frame: at intensive care discharge, within a limit of 28 days, at 3 months
Comparison of malnutrition into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
Time frame: at intensive care discharge, within a limit of 28 days, at 3 months
Comparison of malnutrition into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
Time frame: at intensive care discharge, within a limit of 28 days, at 3 months
Comparison of calorie intake into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
Time frame: through study completion, an average of 1 year
Comparison of drug intake into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
Time frame: through study completion, an average of 1 year
Comparison of drug intake into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
Time frame: through study completion, an average of 1 year
Comparison of drug intake into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
Time frame: through study completion, an average of 1 year
Comparison of drug intake into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
Time frame: During stay in intensive care
Comparison of drug intake into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)
Time frame: through study completion, an average of 1 year
Results and safety
The study was stopped early (reason given: missing data, little recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available to other researchers
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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.
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 Amyotrophia and Weakness, Muscle, run by Association Pro-arte 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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 3 Feb 2023. 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 was stopped early (reason given: missing data, little recruitment). Results are not available in the source record.
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?
Determination of the day of ultrasound examination having the highest diagnostic performance to predict with a maximum of specificity the occurrence of a neuromuscular weakness syndrome post-intensive care unit (time frame: through study completion, an average of 1 year). 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 3 Feb 2023.