Physical Therapist Inter-Rater Reliability in Neuro-Muscle Ultrasound in Critically Ill Patients
ConditionCritical Illness
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Chile
About this trial
The goal of this observational study is to evaluate the feasibility and inter-rater reliability of muscle and peripheral nerve ultrasound for the early detection of ICU-acquired weakness (ICU-AW) in critically ill patients.
The main questions it aims to answer are:
Can ICU physical therapists consistently measure muscle and nerve ultrasound variables such as muscle thickness, cross-sectional area, pennation angle, and echogenicity in critically ill patients?
Do clinical scales (MRC-SS and FSS-ICU) show inter-evaluator agreement and correlate with ultrasound findings?
Participants are adult ICU patients at Clínica INDISA who are undergoing routine neuromuscular assessments by trained physical therapists. Each patient will be evaluated by three independent raters using ultrasound and standardized clinical scales. Data will be collected and analyzed to determine inter-rater reliability and correlations between clinical and imaging findings.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (≥18 years old) admitted to the Adult Intensive Care Unit (ICU) of Clínica INDISA.
Conscious and clinically stable at the time of assessment.
Able to provide written informed consent.
Disqualifiers
Known allergy to ultrasound gel.
Body mass index (BMI) ≥ 30 kg/m².
Pre-existing neuromuscular disease.
Continuous renal replacement therapy or severe hepatic coagulopathy.
Trial population
The study population consists of adult patients admitted to the Adult Intensive Care Unit (ICU) of Clínica INDISA in Santiago, Chile. Participants will be selected during their hospitalization for critical illness and evaluated on a randomly chosen day during their ICU stay. All participants will be physically and cognitively able to provide informed consent.
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
37 Participants
are grouped into 1 trial groupGroup A: Critically Ill Patients
Trial outcomes
Primary outcomes
1
Inter-rater reliability of quadriceps muscle ultrasound measurements
Intraclass correlation coefficient (ICC) between three evaluators for ultrasound variables including quadriceps muscle thickness, rectus femoris and vastus intermedius cross-sectional area, and pennation angle.
Time frame
Assessed once within 60 days following ICU admission2
Peripheral Nerve Ultrasound Inter-Rater Reliability
Intraclass correlation coefficient (ICC) between three evaluators for cross-sectional area and echogenicity of peripheral nerves (median, ulnar, tibial, and fibular) measured by ultrasound.
Time frame
Assessed once within 60 days following ICU admissionSecondary outcomes
1
Inter-rater agreement of Functional Status Score for the ICU (FSS-ICU)
Kendall's W coefficient to assess the level of agreement among three physical therapists applying the FSS-ICU scale in critically ill patients.
Time frame
Assessed once within 60 days following ICU admission2
Inter-Rater Agreement of MRC Sum Score
Kendall's W coefficient to determine the agreement between three physical therapists applying the MRC-SS to assess muscle strength in ICU patients.
Time frame
Assessed once within 60 days following ICU admission3
Correlation between clinical scales and ultrasound findings
Pearson or Spearman correlation coefficients between MRC-SS/FSS-ICU results and quantitative ultrasound parameters.
Time frame
Assessed once within 60 days following ICU admissionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Chile
Lead sponsor
Clinica Indisa
Collaborator
Source ClinicalTrials.gov