Disease Severity, Mortality Risk, and Muscle Function in Intensive Care Unit Patients

NCT07124442 | Recruiting

• 1 other identifier: Istinye BT 2
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Intensive Care Units are specialized, technologically advanced hospital units that provide continuous monitoring and care from multiple healthcare disciplines for patients who are critically ill and face a high risk of death or serious health problems. Prolonged periods of immobility, which are common during treatment in these units, can cause serious complications such as muscle weakness, decline in physical function, and a lower quality of life. There are scoring systems designed to predict the severity of a patient's illness and their likely outcomes, such as the scoring system called the Acute Physiology and Chronic Health Evaluation version two. However, these scoring systems are not yet widely used as a regular part of patient care. Although weakness and wasting of muscles away from the center of the body are known to affect the recovery process of patients who survive intensive care treatment, the connection between how severe the illness is and the strength of the muscles used for breathing, the structure of peripheral muscles, and their biomechanical characteristics is still not fully understood. This study aims to explore these relationships to help improve physiotherapy and rehabilitation treatments for patients in intensive care.

Conditions

Critically Ill Patients

Keywords

Critically ill patients; Respiratory muscle; Skeletal muscle

Outcome Measures

Primary Outcomes (2)

• Course of Disease in Intensive Care Patients, Mortality risk:

  The patient's mortality rate will be assessed using the Acute Physiology and Chronic Health Evaluation II score. The Acute Physiology and Chronic Health Evaluation II score is commonly used for patients treated in the intensive care unit. It is based on an initial score comprising 12 components and is evaluated on a scale from 0 to 71 points. The assessment consists of three sections: physiological scores ranging from 0-60 points, age scores ranging from 0-6 points, and comorbidity scores ranging from 0-5 points. A higher total Acute Physiology and Chronic Health Evaluation II score indicates greater severity of the patient's condition (15).

  4 weeks

• Assessment of Peripheral Muscle Architecture:

  Quadriceps femoris muscle thickness will be measured as the distance between the upper border of the femur and the lower border of the subcutaneous tissue. Measurements will be taken 15 cm proximal to the superior border of the patella using a tape measure (19). After each patient, the ultrasound probe will be disinfected by wiping with 70% isopropyl alcohol.

  4 weeks

Secondary Outcomes (6)

• Muscle Tone:

  4 weeks

• Measurement of Respiratory Muscle Strength:

  4 weeks

• Elasticity:

  4 weeks

• Dynamic Stiffness

  4 weeks

• Creep:

  4 weeks

Study Arms (1)

Critical care patient

Critical care patients are going to be meaasured

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients admitted to the intensive care unit who are not dependent on mechanical ventilation and meet the inclusion and exclusion criteria will be included in the study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

Istinye University Bahçeşehir Liv University Hospital

Istanbul, Esenyurt, 34000, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Beyza Tanrıöğen, MSc

CONTACT

00905392359936; beyza.tanriogen@istinye.edu.tr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant (PhD student)

Study Record Dates

• First Submitted: August 9, 2025
• First Posted: August 15, 2025
• Study Start: August 15, 2025
• Primary Completion: September 15, 2025
• Study Completion: October 30, 2025
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

TU (1)