Critically Ill PatientsNCT07124442
Disease Severity, Mortality Risk, and Muscle Function in Intensive Care Unit Patients
An observational study of Critically Ill Patients, run by Istinye University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill Patients
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2025to 30 Oct 2025
- How long will I take part?
- 1 Day
- 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: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istinye University Bahçeşehir Liv University Hospital
Istanbul, Esenyurt, 34000
Beyza Tanrıöğen, MSc
About this study
Official title: Relationship of Disease Severity and Mortality Risk With Respiratory Muscle Strength, Muscle Biomechanical Properties, and Muscle Architecture in Intensive Care Unit Patients
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.
Read the detailed description
Intensive Care Units are specialized and high-cost hospital units equipped with advanced technology, designed for the treatment and continuous monitoring of critically ill patients who are at risk of losing, or have already lost, some or all of their vital bodily functions. These units provide twenty-four-hour monitoring of vital signs, operate with a multidisciplinary healthcare team, and have privileged status in terms of patient care (1). The most common reasons for admission to Intensive Care Units include acute heart attacks, severe breathing difficulties, heart bypass surgeries, congestive heart failure, strokes or bleeding within the brain, cardiovascular system problems, pneumonia, widespread infections called sepsis, diabetic ketoacidosis, gastrointestinal bleeding, and other serious health conditions (2). Among these, the most frequent reason for admission is respiratory failure that requires mechanical support to assist or take over breathing (3). The period of critical illness can last from a few hours to several months depending on the underlying disease process and how the patient responds to treatment, and it is associated with high rates of death and serious health problems (4).
Patients treated in Intensive Care Units face various problems that either develop during their stay or exist beforehand and continue. These problems include muscle weakness, cognitive difficulties, psychological challenges, worsening physical function, and reductions in quality of life and the ability to perform daily activities (5). Bed rest or immobilization is often a necessary part of treatment in Intensive Care Units (3). Prolonged immobility can cause many clinical complications that may be severe and last a long time, leading to physical limitations and negatively affecting quality of life over the long term (6). Research has identified bed rest as harmful because it can cause complications such as fluid buildup in the lungs, collapse of parts of the lungs, loss of bone density, muscle wasting, instability of blood vessel regulation, constipation, pain, pressure sores, joint contractures, and blood clots (7).
Predictive scoring systems are clinical tools used to evaluate the severity of illness in Intensive Care Unit patients and to predict their prognosis, especially the risk of death (8). These clinical scoring systems help classify patient risk levels, predict health outcomes, and improve other clinical management processes. Although these scoring tools assist physicians in managing patients, they are not routinely used in everyday clinical practice mainly because they are complex and require specific expertise and training (9).
Some of the common scoring systems used for adult patients in Intensive Care Units include the Acute Physiology and Chronic Health Evaluation, the Simplified Acute Physiology Score, the Mortality Prediction Model, the Organ Dysfunction and Infection System, the Sequential Organ Failure Assessment, the Multiple Organ Dysfunction Score, the Logistic Organ Dysfunction Model, and the Three-day Recalibrating Intensive Care Unit Outcomes system (10).
The Acute Physiology and Chronic Health Evaluation scoring system was developed in nineteen eighty-one by the George Washington University Medical Center and is known as one of the most widely used and recognized scales for determining the severity of acute illnesses. The version known as Acute Physiology and Chronic Health Evaluation version two was created for different research and clinical audit purposes and continues to be used extensively to assess disease severity in critically ill patients in Intensive Care Units (11, 12). It is a highly selective and accurate measurement tool that can serve as a standard in Intensive Care Units by enabling evaluation of standardized mortality ratios (12).
Loss of muscle strength and muscle weakness are well known to negatively impact patients in Intensive Care Units. This loss of muscle strength can delay or hinder the recovery of physical function in patients who survive Intensive Care Unit treatment. Additionally, patients who develop muscle weakness due to long stays in Intensive Care Units have been shown by ultrasound measurements to have reduced thickness and cross-sectional area of peripheral muscles compared to patients without muscle weakness (13, 14). However, the relationship between the course and severity of disease and respiratory muscle strength, peripheral muscle thickness, and muscle tone in Intensive Care Unit patients is not yet fully understood. Determining how the course and severity of disease affect respiratory muscle strength, biomechanical properties of peripheral muscles, and muscle structure is critically important for establishing effective physiotherapy and rehabilitation strategies in Intensive Care Units.
The aim of this study is to investigate the relationship between disease severity and respiratory muscle strength, peripheral muscle structure, and the biomechanical properties of peripheral muscles in patients treated in Intensive Care Units. This study will be conducted using a cross-sectional and observational research design.
- Conditions
- Critically Ill Patients
- Keywords
- Critically ill patients, Respiratory muscle, Skeletal muscle
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 |
|---|---|---|
| Critical care patient | Critical care patients are going to be meaasured |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 4 weeks
Secondary outcomes (6)
Muscle Tone:
Peripheral muscle stiffness will be assessed using the MyotonPRO device (Myoton AS, Estonia). Tone refers to the tension of the tissue at rest. There is a direct relationship between the measured value and tissue tension.
Measured: 4 weeks
Measurement of Respiratory Muscle Strength:
Respiratory muscle strength will be assessed using a portable electronic device (Micro Medical Micro RPM, Rochester, UK) to measure maximal inspiratory mouth pressure and maximal expiratory mouth pressure in cmH₂O. Maximal inspiratory mouth pressure is recorded during maximal inspiration against an occluded airway after full expiration, sustained for 1-3 seconds; maximal expiratory mouth pressure is recorded during maximal expiration after full inspiration. The best of three trials will be expressed as a percentage of age- and sex-adjusted reference values. To prevent infection, disposable mouthpieces and filters will be used, with device surfaces disinfected using alcohol-based solutions, and mouthpieces sterilized with ethyl alcohol and specialized equipment.
Measured: 4 weeks
Elasticity:
It will be measured by using the MyotonPRO device (Myoton AS, Estonia). Elasticity is the ability of the tissue to return to its original shape after the removal of deforming forces. Tissue elasticity and the measured value are inversely related; as the logarithmic decrement decreases, the tissue's ability to return to its original shape increases.
Measured: 4 weeks
Dynamic Stiffness
Peripheral muscle stiffness will be assessed using the MyotonPRO device (Myoton AS, Estonia). Dynamic stiffness (measured in Newtons per meter, N/m) is defined as the resistance of soft tissues to destructive external forces. Tissue stiffness and the measured value are inversely related.
Measured: 4 weeks
Creep:
Peripheral muscle stiffness will be assessed using the MyotonPRO device (Myoton AS, Estonia). Creep is the gradual elongation of soft tissue over time under a constant load. It is calculated as the ratio of deformation time to tissue relaxation time. Higher values are typically found in young, healthy muscles.
Measured: 4 weeks
Relaxation Time:
Peripheral muscle stiffness will be assessed using the MyotonPRO device (Myoton AS, Estonia). Relaxation time (measured in milliseconds) is the time required for tissue to recover after deformation or damage. There is a direct relationship between the measured value and the time taken for full recovery.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start15 Aug 2025 (estimated)
- Primary completion15 Sep 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically Ill PatientsStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beyza Tanrıöğen, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124442
- Sponsor's protocol ID
- Istinye BT 2
- Status last verified
- Aug 2025
- First submitted
- 9 Aug 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Disease Severity and Mortality Risk With Respiratory Muscle Strength, Muscle Biomechanical Properties, and Muscle Architecture in Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT07124442
- Acronym / sponsor ID
- Istinye BT 2
- Conditions
- Critically Ill Patients
- Keywords
- Critically ill patients, Respiratory muscle, Skeletal muscle
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 15 Aug 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.
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.
Detailed description
Intensive Care Units are specialized and high-cost hospital units equipped with advanced technology, designed for the treatment and continuous monitoring of critically ill patients who are at risk of losing, or have already lost, some or all of their vital bodily functions. These units provide twenty-four-hour monitoring of vital signs, operate with a multidisciplinary healthcare team, and have privileged status in terms of patient care (1). The most common reasons for admission to Intensive Care Units include acute heart attacks, severe breathing difficulties, heart bypass surgeries, congestive heart failure, strokes or bleeding within the brain, cardiovascular system problems, pneumonia, widespread infections called sepsis, diabetic ketoacidosis, gastrointestinal bleeding, and other serious health conditions (2). Among these, the most frequent reason for admission is respiratory failure that requires mechanical support to assist or take over breathing (3). The period of critical illness can last from a few hours to several months depending on the underlying disease process and how the patient responds to treatment, and it is associated with high rates of death and serious health problems (4).
Patients treated in Intensive Care Units face various problems that either develop during their stay or exist beforehand and continue. These problems include muscle weakness, cognitive difficulties, psychological challenges, worsening physical function, and reductions in quality of life and the ability to perform daily activities (5). Bed rest or immobilization is often a necessary part of treatment in Intensive Care Units (3). Prolonged immobility can cause many clinical complications that may be severe and last a long time, leading to physical limitations and negatively affecting quality of life over the long term (6). Research has identified bed rest as harmful because it can cause complications such as fluid buildup in the lungs, collapse of parts of the lungs, loss of bone density, muscle wasting, instability of blood vessel regulation, constipation, pain, pressure sores, joint contractures, and blood clots (7).
Predictive scoring systems are clinical tools used to evaluate the severity of illness in Intensive Care Unit patients and to predict their prognosis, especially the risk of death (8). These clinical scoring systems help classify patient risk levels, predict health outcomes, and improve other clinical management processes. Although these scoring tools assist physicians in managing patients, they are not routinely used in everyday clinical practice mainly because they are complex and require specific expertise and training (9).
Some of the common scoring systems used for adult patients in Intensive Care Units include the Acute Physiology and Chronic Health Evaluation, the Simplified Acute Physiology Score, the Mortality Prediction Model, the Organ Dysfunction and Infection System, the Sequential Organ Failure Assessment, the Multiple Organ Dysfunction Score, the Logistic Organ Dysfunction Model, and the Three-day Recalibrating Intensive Care Unit Outcomes system (10).
The Acute Physiology and Chronic Health Evaluation scoring system was developed in nineteen eighty-one by the George Washington University Medical Center and is known as one of the most widely used and recognized scales for determining the severity of acute illnesses. The version known as Acute Physiology and Chronic Health Evaluation version two was created for different research and clinical audit purposes and continues to be used extensively to assess disease severity in critically ill patients in Intensive Care Units (11, 12). It is a highly selective and accurate measurement tool that can serve as a standard in Intensive Care Units by enabling evaluation of standardized mortality ratios (12).
Loss of muscle strength and muscle weakness are well known to negatively impact patients in Intensive Care Units. This loss of muscle strength can delay or hinder the recovery of physical function in patients who survive Intensive Care Unit treatment. Additionally, patients who develop muscle weakness due to long stays in Intensive Care Units have been shown by ultrasound measurements to have reduced thickness and cross-sectional area of peripheral muscles compared to patients without muscle weakness (13, 14). However, the relationship between the course and severity of disease and respiratory muscle strength, peripheral muscle thickness, and muscle tone in Intensive Care Unit patients is not yet fully understood. Determining how the course and severity of disease affect respiratory muscle strength, biomechanical properties of peripheral muscles, and muscle structure is critically important for establishing effective physiotherapy and rehabilitation strategies in Intensive Care Units.
The aim of this study is to investigate the relationship between disease severity and respiratory muscle strength, peripheral muscle structure, and the biomechanical properties of peripheral muscles in patients treated in Intensive Care Units. This study will be conducted using a cross-sectional and observational research design.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critical care patient | – | –Critical care patients are going to be meaasured |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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
Course of Disease in Intensive Care Patients, Mortality risk:
Time frame: 4 weeks
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).
Assessment of Peripheral Muscle Architecture:
Time frame: 4 weeks
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.
6 secondary outcomes
Muscle Tone:
Time frame: 4 weeks
Measurement of Respiratory Muscle Strength:
Time frame: 4 weeks
Elasticity:
Time frame: 4 weeks
Dynamic Stiffness
Time frame: 4 weeks
Creep:
Time frame: 4 weeks
Relaxation Time:
Time frame: 4 weeks
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 15 Aug 2025.
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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.
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 Critically Ill Patients, run by Istinye University at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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 15 Aug 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 Turkey (Türkiye). 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 Beyza Tanrıöğen, MSc (00905392359936, beyza.tanriogen@istinye.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Course of Disease in Intensive Care Patients, Mortality risk: (time frame: 4 weeks). 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?
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 15 Aug 2025.