Ultrasound of the Quadriceps Femoris Compared With the Clinical Frailty Scale

NCT06523348 | Not Yet Recruiting

• 2 other identifiers: RC31/24/0180N° ID-RCB
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single-centre prospective diagnostic study. When a patient is admitted to the inclusion centre, the clinician responsible for the patient checks the inclusion and exclusion criteria. The no objection from the patient (or their trusted support person or, failing that, a close if the patient is unable to give consent) is sought.The CFS scale is completed and recorded by the clinician in the observation observation notebook.The clinician performs a quadricipital muscle ultrasound, specifically for research purposes, with no changes to the therapeutic and its results are recorded in the observation notebook. observation notebook.At 3 months after inclusion, information was collected from the medical records to identify secondary endpoints. Translated with DeepL.com (free version)

Conditions

Frailty; Intensive Care Unit Syndrome

Outcome Measures

Primary Outcomes (1)

• Bilateral ultrasound depth of the quadriceps femoris muscle

  Bilateral ultrasound depth of the quadriceps femoris muscle: The ultrasound consists of 3 measurements per side of the thickness of the rectus femoris muscle. The ultrasound loops will be recorded on an ultrasound machine (GE) after anonymisation. The images will be analysed a posteriori by the principal investigator and the associate investigators, experts in ultrasound analysis of this muscle.

  24 hours

Interventions

quadricipital muscle ultrasound DIAGNOSTIC_TEST

ultrasound depth measurement of the quadriceps muscle

Eligibility Criteria

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

Study Population

Any patient aged 65 or over admitted to intensive care or the emergency department who meets the eligibility criteria

You may qualify if:

• patient aged 65 or over
• admitted to intensive care or the outpatient department for less than 24 hours
• with an abdominal CT scan less than 30 days prior to admission OR who are scheduled for an scheduled for a routine abdomino-pelvic CT scan within the first 24 hours of admission

You may not qualify if:

• Neuromuscular disease
• Lower limb amputation
• Paraplegia \> 24 hours before admission
• Clearly infected, burnt or lacerated ultrasound site.
• Guardianship or curatorship
• Opposition of the patient or his/her trusted support person or relative
• Abdominal and pelvic CT scan not available in the previous month and not scheduled within the first 24 hours of treatment

Sponsors & Collaborators

• University Hospital, Toulouse: lead

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Fanny BOUNES, PH

CONTACT

+33 5 61 32 23 11; bounes.f@chu-toulouse.fr

Study Design

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

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: August 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share