Clínica INDISA
Santiago, Metropolitan Region, 7500912, Chile
Location status: Recruiting
NCT Number: NCT07032870
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Santiago, Metropolitan Region, 7500912, Chile
Location status: Recruiting
This observational, cross-sectional pilot study aims to assess the inter-rater reliability of muscle and peripheral nerve ultrasound and functional clinical scales in the diagnosis of ICU-acquired weakness (ICU-AW). The study involves adult patients admitted to the Adult Critical Care Unit at Clínica INDISA (Santiago, Chile). Participants will undergo muscle ultrasound of the quadriceps (measuring anterior compartment thickness, cross-sectional area, and pennation angle) and peripheral nerve ultrasound (assessing cross-sectional area and echogenicity of specific nerves) performed by three trained physical therapists. Clinical assessments using the MRC Sum Score (MRC-SS) and the Functional Status Score for the ICU (FSS-ICU) will also be performed by each rater.
The main aim is to evaluate the agreement between raters using the intraclass correlation coefficient (ICC) for ultrasound variables and Kendall's W for functional scales. The study will also explore correlations between clinical scores and ultrasound findings using Pearson or Spearman correlation coefficients. Echogenicity will be quantified using ImageJ software.
All procedures are performed at bedside using portable ultrasound equipment, and evaluations follow safety guidelines for critically ill patients. The results of this study will contribute to validating physical therapists as reliable operators for early identification of ICU-AW using ultrasound-based tools and standardized clinical assessments.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Assessed once within 60 days following ICU admission
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 admission
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 admission
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 admission
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 admission
Pearson or Spearman correlation coefficients between MRC-SS/FSS-ICU results and quantitative ultrasound parameters.
Interested in participating?
Request InfoUniversity of Chile
Other
Pilot Study: Validation of Operators and Inter-Evaluator Variability in Diagnostic Strategies for ICU-Acquired Weakness (NMusICU-R)
Acronym: NMusICU-R
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07173855
Arrhythmias, Cardiac, Atrial Fibrillation
Ajax, Ontario, Canada
View Trial DetailsNCT07839949
Critical Illness, Disease Attributes
Palma de Mallorca, Balearic Islands, Spain
View Trial DetailsNCT07837128
Critical Illness, Disease Attributes
Amsterdam, NL, Netherlands
View Trial DetailsNCT07680816
Critical Illness, Disease Attributes
Wuhan, Outside of the US, China
View Trial Details