Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-28 @ 12:08 AM
Study NCT ID:
NCT03735693
Status:
TERMINATED
Last Update Posted:
2023-02-03
First Post:
2018-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnosis of Muscular Weakness Syndrome After a Stay in Intensive Care : Measurement by Ultrasound
Sponsor:
Association Pro-arte
Organization:
Study Overview
Official Title:
Diagnosis of Muscular Weakness Syndrome After a Stay in Intensive Care : Measurement by Ultrasound
Status:
TERMINATED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
missing data, little recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIBER
Brief 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. 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).
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: