Diagnosis of Muscular Weakness Syndrome After a Stay in Intensive Care : Measurement by Ultrasound

NCT03735693 | Terminated

• 1 other identifier: 3-2018-FIBER
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Amyotrophia; Weakness, Muscle

Keywords

ultrasound; intensive care

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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)

  3 months after discharge from hospital

• comparison of functional alteration into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)

  3 months after discharge from hospital

• comparison of functional alteration into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)

  3 months after discharge from hospital

• comparison of functional alteration into 2 cohorts of patients (probably not affected by the syndrome, and probably affected)

  3 months after discharge from hospital

Interventions

Ulstrasound DIAGNOSTIC_TEST

measurement of right femoral cross-section

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study concerns people admitted in intensive care unit, intubated and ventilated.

You may qualify if:

• 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

You may not qualify if:

• 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
• Persons referred to in Articles L1121-5 to L1121-8 of the CSP

Sponsors & Collaborators

• Association Pro-arte: lead

Study Sites (1)

CHU Grenoble Alpes

Grenoble, 38000, France

Location

MeSH Terms

Conditions

Muscular Atrophy; Muscle Weakness

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 8, 2018
• Study Start: September 14, 2018
• Primary Completion: December 14, 2021
• Study Completion: February 2, 2022
• Last Updated: February 3, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)