Critical IllnessNMusICU-RNCT07032870
Physical Therapist Inter-Rater Reliability in Neuro-Muscle Ultrasound in Critically Ill Patients
An observational study of Critical Illness, run by University of Chile at 1 site in Chile.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- How many people
- 37 participants
- Where
- 1 siteChile
- Study dates
- 8 Feb 2025to 9 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- Known allergy to ultrasound gel.
- Body mass index (BMI) ≥ 30 kg/m².
- Pre-existing neuromuscular disease.
- Continuous renal replacement therapy or severe hepatic coagulopathy.
- Platelet count < 20,000/µL.
- Lower limb amputation or recent fractures.
- Ongoing chemotherapy or immunosuppressive treatment with corticosteroids.
- Epileptic status or pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site, 1 recruiting
- Recruiting
Clínica INDISA
Santiago, Metropolitan Region, 7500912
Felipe A Castillo, MSc., +56992246802, felipe.castillo@indisa.cl
Óscar L Arellano, MSc. PhD Candidate, +56961479414, oscar.arellano@ug.uchile.cl
About this study
Official title: Pilot Study: Validation of Operators and Inter-Evaluator Variability in Diagnostic Strategies for ICU-Acquired Weakness (NMusICU-R)
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:
Read more
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.
Read the detailed description
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.
- Conditions
- Critical Illness
- Keywords
- critical illness, ultrasound, Inter-rater reliability, physical therapist
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Critically Ill Patients | Adult ICU patients at Clínica INDISA evaluated by three physical therapists using bedside ultrasound of the quadriceps muscle and peripheral nerves, and assessed with clinical scales (MRC-SS and FSS-ICU) to measure inter-rater reliability and correlation of results. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed once within 60 days following ICU admission
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.
Measured: Assessed once within 60 days following ICU admission
Secondary outcomes (3)
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.
Measured: Assessed once within 60 days following ICU admission
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.
Measured: Assessed once within 60 days following ICU admission
Correlation between clinical scales and ultrasound findings
Pearson or Spearman correlation coefficients between MRC-SS/FSS-ICU results and quantitative ultrasound parameters.
Measured: Assessed once within 60 days following ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start8 Feb 2025
- Primary completion9 Dec 2025 (estimated)
- Study completion9 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Clinica Indisa
- Responsible party
- Principal investigator, Oscar Arellano, University of Chile
- Investigators
- Paola A Llanos, PhD, Study chair, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032870
- Sponsor's protocol ID
- 176-25-24
- Acronym
- NMusICU-R
- Status last verified
- Jul 2025
- First submitted
- 11 Jun 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical and legal restrictions. Only aggregate results derived from the analysis of anonymized data will be published in scientific articles. This decision follows the confidentiality agreements established in the informed consent and the approval granted by the institutional ethics committee.
Publications
Lefaucheur JP, Nordine T, Rodriguez P, Brochard L. Origin of ICU acquired paresis determined by direct muscle stimulation. J Neurol Neurosurg Psychiatry. 2006 Apr;77(4):500-6. doi: 10.1136/jnnp.2005.070813. Epub 2005 Nov 23.
PubMed 16306155Formenti P, Umbrello M, Coppola S, Froio S, Chiumello D. Clinical review: peripheral muscular ultrasound in the ICU. Ann Intensive Care. 2019 May 17;9(1):57. doi: 10.1186/s13613-019-0531-x.
PubMed 31101987Paolo F, Valentina G, Silvia C, Tommaso P, Elena C, Martin D, Marini John J, Davide C. The possible predictive value of muscle ultrasound in the diagnosis of ICUAW in long-term critically ill patients. J Crit Care. 2022 Oct;71:154104. doi: 10.1016/j.jcrc.2022.154104. Epub 2022 Jul 4.
PubMed 35797827Lad H, Saumur TM, Herridge MS, Dos Santos CC, Mathur S, Batt J, Gilbert PM. Intensive Care Unit-Acquired Weakness: Not just Another Muscle Atrophying Condition. Int J Mol Sci. 2020 Oct 22;21(21):7840. doi: 10.3390/ijms21217840.
PubMed 33105809Elkalawy H, Sekhar P, Abosena W. Early detection and assessment of intensive care unit-acquired weakness: a comprehensive review. Acute Crit Care. 2023 Nov;38(4):409-424. doi: 10.4266/acc.2023.00703. Epub 2023 Nov 30.
PubMed 38052508Rajagopal K, Vijayan D, Thomas SM. Association of SOFA Score with Severity of Muscle Wasting in Critically Ill Patients: A Prospective Observational Study. Indian J Crit Care Med. 2023 Oct;27(10):743-747. doi: 10.5005/jp-journals-10071-24540.
PubMed 37908434Beekman R, Visser LH. High-resolution sonography of the peripheral nervous system -- a review of the literature. Eur J Neurol. 2004 May;11(5):305-14. doi: 10.1111/j.1468-1331.2004.00773.x.
PubMed 15142223Gruber L, Loizides A, Gruber H, Skalla E, Haushammer S, Horlings C, Beer R, Helbok R, Loscher WN. Differentiation of Critical Illness Myopathy and Critical Illness Neuropathy Using Nerve Ultrasonography. J Clin Neurophysiol. 2023 Nov 1;40(7):600-607. doi: 10.1097/WNP.0000000000000922. Epub 2022 Jan 25.
PubMed 35089907Grimm A, Decard BF, Axer H, Fuhr P. The Ultrasound pattern sum score - UPSS. A new method to differentiate acute and subacute neuropathies using ultrasound of the peripheral nerves. Clin Neurophysiol. 2015 Nov;126(11):2216-25. doi: 10.1016/j.clinph.2015.01.011. Epub 2015 Feb 3.
PubMed 25691156Hadda V, Khilnani GC, Kumar R, Dhunguna A, Mittal S, Khan MA, Madan K, Mohan A, Guleria R. Intra- and Inter-observer Reliability of Quadriceps Muscle Thickness Measured with Bedside Ultrasonography by Critical Care Physicians. Indian J Crit Care Med. 2017 Jul;21(7):448-452. doi: 10.4103/ijccm.IJCCM_426_16.
PubMed 28808365Di Matteo A, Moscioni E, Lommano MG, Cipolletta E, Smerilli G, Farah S, Airoldi C, Aydin SZ, Becciolini A, Bonfiglioli K, Carotti M, Carrara G, Cazenave T, Corradini D, Cosatti MA, de Agustin JJ, Destro Castaniti GM, Di Carlo M, Di Donato E, Di Geso L, Elliott A, Fodor D, Francioso F, Gabba A, Hernandez-Diaz C, Horvath R, Hurnakova J, Jesus D, Marin J, Martire MV, Mashadi Mirza R, Massarotti M, Musca AA, Nair J, Okano T, Papalopoulos I, Rosa J, Rosemffet M, Rovisco J, Rozza D, Salaffi F, Scioscia C, Scire CA, Tamas MM, Tanimura S, Ventura-Rios L, Villota-Eraso C, Villota O, Voulgari PV, Vreju FA, Vukatana G, Hereter JZ, Zanetti A, Grassi W, Filippucci E. Reliability assessment of ultrasound muscle echogenicity in patients with rheumatic diseases: Results of a multicenter international web-based study. Front Med (Lausanne). 2023 Jan 17;9:1090468. doi: 10.3389/fmed.2022.1090468. eCollection 2022.
PubMed 36733934Pardo E, El Behi H, Boizeau P, Verdonk F, Alberti C, Lescot T. Reliability of ultrasound measurements of quadriceps muscle thickness in critically ill patients. BMC Anesthesiol. 2018 Dec 27;18(1):205. doi: 10.1186/s12871-018-0647-9.
PubMed 30591032Karapinar M, Atilla Ayyildiz V, Unal M, Firat T. Ultrasound imaging of quadriceps muscle in patients with knee osteoarthritis: The test-retest and inter-rater reliability and concurrent validity of echo intensity measurement. Musculoskelet Sci Pract. 2021 Dec;56:102453. doi: 10.1016/j.msksp.2021.102453. Epub 2021 Sep 1.
PubMed 34507044Turan Z, Topaloglu M, Ozyemisci Taskiran O. Medical Research Council-sumscore: a tool for evaluating muscle weakness in patients with post-intensive care syndrome. Crit Care. 2020 Sep 18;24(1):562. doi: 10.1186/s13054-020-03282-x. No abstract available.
PubMed 32948221Derde S, Hermans G, Derese I, Guiza F, Hedstrom Y, Wouters PJ, Bruyninckx F, D'Hoore A, Larsson L, Van den Berghe G, Vanhorebeek I. Muscle atrophy and preferential loss of myosin in prolonged critically ill patients. Crit Care Med. 2012 Jan;40(1):79-89. doi: 10.1097/CCM.0b013e31822d7c18.
PubMed 21926599
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Validation of Operators and Inter-Evaluator Variability in Diagnostic Strategies for ICU-Acquired Weakness (NMusICU-R)
- ClinicalTrials.gov ID
- NCT07032870
- Acronym / sponsor ID
- NMusICU-R / 176-25-24
- Conditions
- Critical Illness
- Keywords
- critical illness, ultrasound, Inter-rater reliability, physical therapist
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Clinica Indisa
- Study start
- 8 Feb 2025 (actual)
- Primary completion
- 9 Dec 2025 (estimated)
- Study completion
- 9 Dec 2025 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically Ill Patients | – | –Adult ICU patients at Clínica INDISA evaluated by three physical therapists using bedside ultrasound of the quadriceps muscle and peripheral nerves, and assessed with clinical scales (MRC-SS and FSS-ICU) to measure inter-rater reliability and correlation of results. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- Known allergy to ultrasound gel.
- Body mass index (BMI) ≥ 30 kg/m².
- Pre-existing neuromuscular disease.
- Continuous renal replacement therapy or severe hepatic coagulopathy.
- Platelet count < 20,000/µL.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inter-rater reliability of quadriceps muscle ultrasound measurements
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.
Peripheral Nerve Ultrasound Inter-Rater Reliability
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.
3 secondary outcomes
Inter-rater agreement of Functional Status Score for the ICU (FSS-ICU)
Time frame: Assessed once within 60 days following ICU admission
Inter-Rater Agreement of MRC Sum Score
Time frame: Assessed once within 60 days following ICU admission
Correlation between clinical scales and ultrasound findings
Time frame: Assessed once within 60 days following ICU admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Background: PubMed 16306155Lefaucheur JP, Nordine T, Rodriguez P, Brochard L. Origin of ICU acquired paresis determined by direct muscle stimulation. J Neurol Neurosurg Psychiatry. 2006 Apr;77(4):500-6. doi: 10.1136/jnnp.2005.070813. Epub 2005 Nov 23.
- Background: PubMed 31101987Formenti P, Umbrello M, Coppola S, Froio S, Chiumello D. Clinical review: peripheral muscular ultrasound in the ICU. Ann Intensive Care. 2019 May 17;9(1):57. doi: 10.1186/s13613-019-0531-x.
- Background: PubMed 35797827Paolo F, Valentina G, Silvia C, Tommaso P, Elena C, Martin D, Marini John J, Davide C. The possible predictive value of muscle ultrasound in the diagnosis of ICUAW in long-term critically ill patients. J Crit Care. 2022 Oct;71:154104. doi: 10.1016/j.jcrc.2022.154104. Epub 2022 Jul 4.
- Background: PubMed 33105809Lad H, Saumur TM, Herridge MS, Dos Santos CC, Mathur S, Batt J, Gilbert PM. Intensive Care Unit-Acquired Weakness: Not just Another Muscle Atrophying Condition. Int J Mol Sci. 2020 Oct 22;21(21):7840. doi: 10.3390/ijms21217840.
- Background: PubMed 38052508Elkalawy H, Sekhar P, Abosena W. Early detection and assessment of intensive care unit-acquired weakness: a comprehensive review. Acute Crit Care. 2023 Nov;38(4):409-424. doi: 10.4266/acc.2023.00703. Epub 2023 Nov 30.
- Background: PubMed 37908434Rajagopal K, Vijayan D, Thomas SM. Association of SOFA Score with Severity of Muscle Wasting in Critically Ill Patients: A Prospective Observational Study. Indian J Crit Care Med. 2023 Oct;27(10):743-747. doi: 10.5005/jp-journals-10071-24540.
- Background: PubMed 15142223Beekman R, Visser LH. High-resolution sonography of the peripheral nervous system -- a review of the literature. Eur J Neurol. 2004 May;11(5):305-14. doi: 10.1111/j.1468-1331.2004.00773.x.
- Background: PubMed 35089907Gruber L, Loizides A, Gruber H, Skalla E, Haushammer S, Horlings C, Beer R, Helbok R, Loscher WN. Differentiation of Critical Illness Myopathy and Critical Illness Neuropathy Using Nerve Ultrasonography. J Clin Neurophysiol. 2023 Nov 1;40(7):600-607. doi: 10.1097/WNP.0000000000000922. Epub 2022 Jan 25.
- Background: PubMed 25691156Grimm A, Decard BF, Axer H, Fuhr P. The Ultrasound pattern sum score - UPSS. A new method to differentiate acute and subacute neuropathies using ultrasound of the peripheral nerves. Clin Neurophysiol. 2015 Nov;126(11):2216-25. doi: 10.1016/j.clinph.2015.01.011. Epub 2015 Feb 3.
- Background: PubMed 28808365Hadda V, Khilnani GC, Kumar R, Dhunguna A, Mittal S, Khan MA, Madan K, Mohan A, Guleria R. Intra- and Inter-observer Reliability of Quadriceps Muscle Thickness Measured with Bedside Ultrasonography by Critical Care Physicians. Indian J Crit Care Med. 2017 Jul;21(7):448-452. doi: 10.4103/ijccm.IJCCM_426_16.
- Background: PubMed 36733934Di Matteo A, Moscioni E, Lommano MG, Cipolletta E, Smerilli G, Farah S, Airoldi C, Aydin SZ, Becciolini A, Bonfiglioli K, Carotti M, Carrara G, Cazenave T, Corradini D, Cosatti MA, de Agustin JJ, Destro Castaniti GM, Di Carlo M, Di Donato E, Di Geso L, Elliott A, Fodor D, Francioso F, Gabba A, Hernandez-Diaz C, Horvath R, Hurnakova J, Jesus D, Marin J, Martire MV, Mashadi Mirza R, Massarotti M, Musca AA, Nair J, Okano T, Papalopoulos I, Rosa J, Rosemffet M, Rovisco J, Rozza D, Salaffi F, Scioscia C, Scire CA, Tamas MM, Tanimura S, Ventura-Rios L, Villota-Eraso C, Villota O, Voulgari PV, Vreju FA, Vukatana G, Hereter JZ, Zanetti A, Grassi W, Filippucci E. Reliability assessment of ultrasound muscle echogenicity in patients with rheumatic diseases: Results of a multicenter international web-based study. Front Med (Lausanne). 2023 Jan 17;9:1090468. doi: 10.3389/fmed.2022.1090468. eCollection 2022.
- Background: PubMed 30591032Pardo E, El Behi H, Boizeau P, Verdonk F, Alberti C, Lescot T. Reliability of ultrasound measurements of quadriceps muscle thickness in critically ill patients. BMC Anesthesiol. 2018 Dec 27;18(1):205. doi: 10.1186/s12871-018-0647-9.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical and legal restrictions. Only aggregate results derived from the analysis of anonymized data will be published in scientific articles. This decision follows the confidentiality agreements established in the informed consent and the approval granted by the institutional ethics committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paola A Llanos, PhD study chair
University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by University of Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Óscar L Arellano, MSc. PhD Candidate (+56961479414, oscar.arellano@ug.uchile.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-rater reliability of quadriceps muscle ultrasound measurements (time frame: Assessed once within 60 days following ICU admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07032870, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.