Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06523348
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Ultrasound of the Quadriceps Femoris Compared With the Clinical Frailty Scale
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Ultrasound of the Quadriceps Femoris for the Diagnosis of Frailty in the Intensive Care Unit Compared With the Clinical Frailty Scale CFS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
QUADRI-REA
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 soughtThe CFS scale is completed and recorded by the clinician in the observation observation notebookThe 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 notebookAt 3 months after inclusion information was collected from the medical records to identify secondary endpoints
Translated with DeepLcom free version
observation notebookAt 3 months after inclusion information was collected from the medical records to identify secondary endpoints
Translated with DeepLcom free version
Detailed Description:
Fragility is defined as a decline in physical and mental capacities leading to increased vulnerability to pathologies It is now accepted that frail patients have a higher morbidity and mortality rate than non-frail patients In intensive care the prevalence of frail patients reaches 30 of patients admitted These patients have a higher rate of complications and mortality than non-fragile patientsIdentifying frail patients is therefore a major challenge in the ICU to enable the risk of short-term mortality to be stratification of the risk of mortality in the short medium and long term and to predict the risk of complicationsThere are a large number of tools for diagnosing frailty but not all of them can be used or validated in the ICU intensive care unit The need for a tool that is robust reliable reproducible and quick to use means that the CFS Clinical Frailty Scale a good tool for screening for frailty particularly in intensive care It predicts mortality in intensive care and in hospital regardless of age However it requires the cooperation of the patient or the patients family and relies on a subjective approach to the patients state of health by the clinician This is why in recent years new objective tools for diagnosing frailty have been developed based in particular on anthropometric measurements The scanographic cross-sectional area of the psoas muscle appears to correlate well with fragility scales in the literature and is an independent risk factor for mortality
Ultrasound depth of the quadriceps muscle is an easy rapid and objective measure of the patients muscle reserves In the preoperative situation this measurement correlates with fragility scales and is a risk factor for postoperative morbidity
We propose to evaluate the diagnostic performance of bilateral ultrasound depth of the quadriceps femoris in comparison with the CFS scale to differentiate frail and non-frail patients in the intensive care unit
Knowing whether the patient is fragile or not quickly and objectively can help the doctor among other things to define a reasonable level of therapeutic commitment for the patient and his or her pathology
to define a reasonable level of therapeutic commitment for the patient and his or her pathology
Ultrasound depth of the quadriceps muscle is an easy rapid and objective measure of the patients muscle reserves In the preoperative situation this measurement correlates with fragility scales and is a risk factor for postoperative morbidity
We propose to evaluate the diagnostic performance of bilateral ultrasound depth of the quadriceps femoris in comparison with the CFS scale to differentiate frail and non-frail patients in the intensive care unit
Knowing whether the patient is fragile or not quickly and objectively can help the doctor among other things to define a reasonable level of therapeutic commitment for the patient and his or her pathology
to define a reasonable level of therapeutic commitment for the patient and his or her pathology
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None