How illness severity and death risk relate to breathing and limb muscle strength in ICU patients

Relationship of Disease Severity and Mortality Risk With Respiratory Muscle Strength, Muscle Biomechanical Properties, and Muscle Architecture in Intensive Care Unit Patients

This project will see if how sick ICU patients are and their risk of dying are linked to the strength of their respiratory and skeletal muscles for adults in the ICU.

Quick facts

• Study type: Observational
• Enrollment: 45 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Istinye University (other)
• Locations: 1 site (Istanbul, Esenyurt)
• Trial ID: NCT07124442 on ClinicalTrials.gov

What this trial studies

This is an observational study enrolling adult ICU patients monitored for at least 48 hours to measure illness severity scores and muscle function without changing clinical care. Investigators will record established severity measures (for example APACHE II) alongside tests of respiratory and peripheral muscle strength and physical function where patients can cooperate. Patients with neuromuscular disease, inability to consent or cooperate, or skin lesions at measurement sites are excluded. The single-site study is conducted at Istinye University Bahçeşehir Liv University Hospital in Istanbul and follows patients during their ICU stay to describe relationships between severity, mortality risk, and muscle function.

Who should consider this trial

Good fit: Adults aged 18 or older who are monitored in the ICU for at least 48 hours at the study hospital, are not dependent on mechanical ventilation, and can provide consent or have a legal representative to consent.

Not a fit: Patients who are mechanically ventilated, have underlying neuromuscular disease, cannot cooperate due to impaired consciousness or communication, or have skin lesions at measurement sites are unlikely to benefit from this observational data collection.

Why it matters

Potential benefit: If successful, the findings could help clinicians identify ICU patients at higher risk of prolonged muscle weakness so they can target monitoring and early rehabilitation.

How similar studies have performed: Prior observational studies have reported links between greater illness severity and ICU-acquired muscle weakness, though using routine severity scores to predict individual outcomes has produced variable results.

Eligibility criteria

Inclusion Criteria:

Not dependent on mechanical ventilation,

Patient or legal representative provides consent to participate,

Aged 18 years or older,

Monitored in the ICU for at least 48 hours.

Exclusion Criteria:

Unable to obtain ethical consent,

Presence of neuromuscular disease affecting muscle tone,

Patients unable to cooperate during measurement due to impaired consciousness, communication disorder, or other medical reasons,

Presence of infection, open wound, or any lesion impairing skin integrity at the anatomical measurement site.

Where this trial is running

Istanbul, Esenyurt

• Istinye University Bahçeşehir Liv University Hospital — Istanbul, Esenyurt, Turkey (Türkiye) (RECRUITING)

Study contacts

• Study coordinator: Beyza Tanrıöğen, MSc

Conditions: Critically Ill Patients, Critically ill patients, Respiratory muscle, Skeletal muscle