ICU StayNCT07860879
Weaning Assessment by Peripheral Muscle Ultrasonography
An observational study of ICU Stay and Muscle Atrophy, run by Taksim Egitim ve Arastirma Hastanesi.
Trial summary
In this study, which aims to investigate the relationship between the weaning process and respiratory muscles-assessed via ultrasonographic measurement of peripheral muscle thickness-in patients over the age of 18 who have been in the intensive care unit for more than 24 hours, we will also examine whether there is a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU Stay, Muscle Atrophy, Ultrasonography
- What is being tested?
- Ultrasonography of peripheral muscle (rectus femoris or vastus intermedius) and Ultrasonography of diaphragma
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 25 Sep 2026to 25 Sep 2027
- 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: Patient group aged 18 and older with an intensive care stay exceeding 24 hours.
Who may be able to join
- Being 18 years of age or older.
- Having been in the intensive care unit for more than 24 hours.
- Having no contraindications to undergoing an ultrasonographic assessment.
Who cannot join
- Known neuromuscular disease.
- Significant motor paralysis due to cervical spinal cord injury or advanced central nervous system lesion.
- Advanced-stage primary muscle disease directly affecting muscle mass.
- Thoracic wall deformity or a condition technically preventing assessment of the diaphragm.
- Amputation, severe peripheral trauma, or local pathology in the muscle to be measured.
- Pregnancy.
- Inability to obtain consent from a legal representative for participation in the study.
- Patients with a very short life expectancy, where it is anticipated that the data collection protocol cannot be completed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Ultrasonographic Assessment of Peripheral Muscles and the Diaphragm in Adult Intensive Care Patients: Relation With Weaning Parameters
In this study, which aims to investigate the relationship between the weaning process and respiratory muscles-assessed via ultrasonographic measurement of peripheral muscle thickness-in patients over the age of 18 who have been in the intensive care unit for more than 24 hours, we will also examine whether there is a significant correlation between peripheral muscle thickness and diaphragm thickness, whether ultrasonographic findings correlate with weaning parameters, and whether peripheral muscle atrophy and diaphragm involvement are parallel or distinct processes.
Read the detailed description
Sarcopenia and muscle atrophy are commonly observed during prolonged stays in the intensive care unit (ICU). This condition is not limited to the extremities but affects all systems containing muscle tissue. Respiratory effort and the function of respiratory muscles are crucial factors during the process of weaning intubated ICU patients from mechanical ventilation. It is known that muscle loss in the ICU is a complex process associated with the severity of critical illness and mechanical ventilation, rather than resulting solely from immobilization; however, there are limited studies examining the relationship between peripheral muscle and the diaphragm in conjunction with weaning parameters. The data obtained from this study could contribute to predicting the weaning process and shaping early rehabilitation strategies in the ICU. The primary objective of this study is to evaluate the relationship between peripheral muscle thickness and diaphragm thickness-measured via ultrasonography-in patients over the age of 18 who have been in the ICU for more than 24 hours. Additionally, the study aims to investigate the impact of changes in muscle thickness on the weaning process and the ICU course, as well as to examine their associations with weaning parameters.
In the study, the following data will be recorded for patients who have stayed in the intensive care unit (ICU) for more than 24 hours: age, gender, height, weight, BMI, ICU admission diagnosis, APACHE II and SOFA scores, presence of culture-confirmed sepsis, total duration of mechanical ventilation, duration of sedation (using the Ramsay Sedation Scale), sedatives/neuromuscular blockers/corticosteroids used, nutritional method and daily protein intake, and laboratory data (albumin, CK, CRP).
Peripheral muscle measurements will be performed via ultrasonography by measuring rectus femoris or vastus intermedius thickness; the total quadriceps muscle thickness may also be recorded as data if desired.
Diaphragm measurements will be based on diaphragm thickness, diaphragm thickening fraction, and-where possible-diaphragm excursion.
Parameters to be recorded regarding weaning include: RSBI, spontaneous breathing trial outcome, MIP/NIF, tidal volume, respiratory rate, P0.1 (if available), extubation success or failure, occurrence of re-extubation within 48 hours, and the need for tracheostomy.
- Being tested
- Ultrasonography of peripheral muscle (rectus femoris or vastus intermedius), Ultrasonography of diaphragma
- Keywords
- muscla ultrasonography, muscle atrophy
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonography of peripheral muscle (rectus femoris or vastus intermedius)Diagnostic test
The measurement of peripheral muscle thickness by ultrasonography. Rectus femoris or vastus intermedius will be measured (Or the total of quadriceps).
Ultrasonography of diaphragmaDiagnostic test
Diaphragm thickness, diaphragm thickening fraction, and, if possible, diaphragm excursion will be measured.
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Coefficient Between Total Quadriceps Muscle Thickness and End-Expiratory Diaphragm Thickness Measured by Ultrasonography
Total quadriceps muscle thickness will be calculated as the sum of rectus femoris and vastus intermedius muscle thicknesses, measured in millimeters using bedside ultrasonography. End-expiratory diaphragm thickness will be measured in millimeters using bedside ultrasonography at the same assessment.
The outcome will be the Pearson or Spearman correlation coefficient between these two measurements across participants, according to the data distribution. The coefficient is dimensionless and ranges from -1 to +1. A separate coefficient will be reported for each scheduled assessment time point.
Baseline assessment will include participants regardless of intubation status. Subsequent assessments will apply to participants who are intubated and those undergoing planned extubation, respectively.
Measured: At ICU admission (baseline); 24-48 hours after intubation; and immediately before planned extubation.
Secondary outcomes (5)
Correlation Coefficient Between Total Quadriceps Muscle Thickness and Diaphragm Thickening Fraction Measured by Ultrasonography
Total quadriceps muscle thickness will be calculated as the sum of rectus femoris and vastus intermedius muscle thicknesses, measured in millimeters using bedside ultrasonography.
Diaphragm thickening fraction will be calculated from ultrasound measurements as: [(end-inspiratory diaphragm thickness - end-expiratory diaphragm thickness) / end-expiratory diaphragm thickness] × 100, and expressed as a percentage.
The outcome will be the Pearson or Spearman correlation coefficient between total quadriceps muscle thickness and diaphragm thickening fraction across participants, according to the data distribution. The coefficient is dimensionless and ranges from -1 to +1. A separate coefficient will be reported for each scheduled assessment time point.
Baseline assessment will include participants regardless of intubation status. Subsequent assessments will apply to participants who are intubated and those undergoing planned extubation, respectively.
Measured: At ICU admission (baseline); 24-48 hours after intubation; and immediately before planned extubation.
Mean Percentage Change From Baseline in Total Quadriceps Muscle Thickness Measured by Ultrasonography
Total quadriceps muscle thickness will be calculated as the sum of rectus femoris and vastus intermedius muscle thicknesses, measured in millimeters using bedside ultrasonography.
For each participant, percentage change from the ICU admission measurement will be calculated as: [(follow-up thickness - baseline thickness) / baseline thickness] × 100. Negative values indicate a reduction in muscle thickness.
The mean of the participant-level percentage changes will be reported separately for each follow-up time point using participants with paired baseline and follow-up measurements. The outcome unit is percent (%).
Measured: From ICU admission (baseline) to 24-48 hours after intubation; and from ICU admission (baseline) to immediately before planned extubation.
Mean Percentage Change From Baseline in End-Expiratory Diaphragm Thickness Measured by Ultrasonography
End-expiratory diaphragm thickness will be measured in millimeters using bedside ultrasonography.
For each participant, percentage change from the ICU admission measurement will be calculated as: [(follow-up thickness - baseline thickness) / baseline thickness] × 100. Negative values indicate a reduction in diaphragm thickness.
The mean of the participant-level percentage changes will be reported separately for each follow-up time point using participants with paired baseline and follow-up measurements. The outcome unit is percent (%).
Measured: From ICU admission (baseline) to 24-48 hours after intubation; and from ICU admission (baseline) to immediately before planned extubation.
Percentage of Participants With Successful Extubation at 48 Hours
Successful extubation will be defined as remaining alive and free from invasive mechanical ventilation throughout the first 48 hours following the first planned extubation during the ICU stay.
Extubation outcome will be determined from clinical follow-up and medical records. The percentage will be calculated as the number of participants meeting the success definition divided by the number of participants undergoing the first planned extubation, multiplied by 100. Noninvasive respiratory support alone will not constitute failure under this definition.
Measured: From the first planned extubation through 48 hours after extubation.
Percentage of Participants Requiring Reintubation Within 48 Hours After Planned Extubation
Reintubation will be defined as reinsertion of an endotracheal tube within 48 hours after the first planned extubation during the ICU stay, as documented in medical records.
The percentage will be calculated as the number of participants requiring reintubation within 48 hours divided by the number of participants undergoing the first planned extubation, multiplied by 100.
Measured: From the first planned extubation through 48 hours after extubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start25 Sep 2026 (estimated)
- Primary completion25 Aug 2027 (estimated)
- Study completion25 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU StayStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Taksim Egitim ve Arastirma Hastanesi
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Canberk Çetinel, Taksim Egitim ve Arastirma Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860879
- Sponsor's protocol ID
- 144
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Assessment of Peripheral Muscles and the Diaphragm in Adult Intensive Care Patients: Relation With Weaning Parameters
- ClinicalTrials.gov ID
- NCT07860879
- Acronym / sponsor ID
- 144
- Keywords
- muscla ultrasonography, muscle atrophy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Taksim Egitim ve Arastirma HastanesiOther government
- Study start
- 25 Sep 2026 (estimated)
- Primary completion
- 25 Aug 2027 (estimated)
- Study completion
- 25 Sep 2027 (estimated)
- First posted
- 6 Oct 2026 (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.
In this study, which aims to investigate the relationship between the weaning process and respiratory muscles-assessed via ultrasonographic measurement of peripheral muscle thickness-in patients over the age of 18 who have been in the intensive care unit for more than 24 hours, we will also examine whether there is a significant correlation between peripheral muscle thickness and diaphragm thickness, whether ultrasonographic findings correlate with weaning parameters, and whether peripheral muscle atrophy and diaphragm involvement are parallel or distinct processes.
Detailed description
Sarcopenia and muscle atrophy are commonly observed during prolonged stays in the intensive care unit (ICU). This condition is not limited to the extremities but affects all systems containing muscle tissue. Respiratory effort and the function of respiratory muscles are crucial factors during the process of weaning intubated ICU patients from mechanical ventilation. It is known that muscle loss in the ICU is a complex process associated with the severity of critical illness and mechanical ventilation, rather than resulting solely from immobilization; however, there are limited studies examining the relationship between peripheral muscle and the diaphragm in conjunction with weaning parameters. The data obtained from this study could contribute to predicting the weaning process and shaping early rehabilitation strategies in the ICU. The primary objective of this study is to evaluate the relationship between peripheral muscle thickness and diaphragm thickness-measured via ultrasonography-in patients over the age of 18 who have been in the ICU for more than 24 hours. Additionally, the study aims to investigate the impact of changes in muscle thickness on the weaning process and the ICU course, as well as to examine their associations with weaning parameters.
In the study, the following data will be recorded for patients who have stayed in the intensive care unit (ICU) for more than 24 hours: age, gender, height, weight, BMI, ICU admission diagnosis, APACHE II and SOFA scores, presence of culture-confirmed sepsis, total duration of mechanical ventilation, duration of sedation (using the Ramsay Sedation Scale), sedatives/neuromuscular blockers/corticosteroids used, nutritional method and daily protein intake, and laboratory data (albumin, CK, CRP).
Peripheral muscle measurements will be performed via ultrasonography by measuring rectus femoris or vastus intermedius thickness; the total quadriceps muscle thickness may also be recorded as data if desired.
Diaphragm measurements will be based on diaphragm thickness, diaphragm thickening fraction, and-where possible-diaphragm excursion.
Parameters to be recorded regarding weaning include: RSBI, spontaneous breathing trial outcome, MIP/NIF, tidal volume, respiratory rate, P0.1 (if available), extubation success or failure, occurrence of re-extubation within 48 hours, and the need for tracheostomy.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient group aged 18 and older with an intensive care stay exceeding 24 hours.
Key inclusion criteria (3 listed)
- Being 18 years of age or older.
- Having been in the intensive care unit for more than 24 hours.
- Having no contraindications to undergoing an ultrasonographic assessment.
Key exclusion criteria (8 listed)
- Known neuromuscular disease.
- Significant motor paralysis due to cervical spinal cord injury or advanced central nervous system lesion.
- Advanced-stage primary muscle disease directly affecting muscle mass.
- Thoracic wall deformity or a condition technically preventing assessment of the diaphragm.
- Amputation, severe peripheral trauma, or local pathology in the muscle to be measured.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasonography of peripheral muscle (rectus femoris or vastus intermedius)The measurement of peripheral muscle thickness by ultrasonography. Rectus femoris or vastus intermedius will be measured (Or the total of quadriceps). | Diagnostic test | – |
| Ultrasonography of diaphragmaDiaphragm thickness, diaphragm thickening fraction, and, if possible, diaphragm excursion will be measured. | Diagnostic test | – |
Primary outcome
Correlation Coefficient Between Total Quadriceps Muscle Thickness and End-Expiratory Diaphragm Thickness Measured by Ultrasonography
Time frame: At ICU admission (baseline); 24-48 hours after intubation; and immediately before planned extubation.
Total quadriceps muscle thickness will be calculated as the sum of rectus femoris and vastus intermedius muscle thicknesses, measured in millimeters using bedside ultrasonography. End-expiratory diaphragm thickness will be measured in millimeters using bedside ultrasonography at the same assessment. The outcome will be the Pearson or Spearman correlation coefficient between these two measurements across participants, according to the data distribution. The coefficient is dimensionless and ranges from -1 to +1. A separate coefficient will be reported for each scheduled assessment time point. Baseline assessment will include participants regardless of intubation status. Subsequent assessments will apply to participants who are intubated and those undergoing planned extubation, respectively.
5 secondary outcomes
Correlation Coefficient Between Total Quadriceps Muscle Thickness and Diaphragm Thickening Fraction Measured by Ultrasonography
Time frame: At ICU admission (baseline); 24-48 hours after intubation; and immediately before planned extubation.
Mean Percentage Change From Baseline in Total Quadriceps Muscle Thickness Measured by Ultrasonography
Time frame: From ICU admission (baseline) to 24-48 hours after intubation; and from ICU admission (baseline) to immediately before planned extubation.
Mean Percentage Change From Baseline in End-Expiratory Diaphragm Thickness Measured by Ultrasonography
Time frame: From ICU admission (baseline) to 24-48 hours after intubation; and from ICU admission (baseline) to immediately before planned extubation.
Percentage of Participants With Successful Extubation at 48 Hours
Time frame: From the first planned extubation through 48 hours after extubation.
Percentage of Participants Requiring Reintubation Within 48 Hours After Planned Extubation
Time frame: From the first planned extubation through 48 hours after extubation.
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 6 Oct 2026.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of ICU Stay and Muscle Atrophy, run by Taksim Egitim ve Arastirma Hastanesi.
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: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Yasemin Tekdöş Şeker Associate Professor, MD (+90 532 475 51 54, yasemintekdos@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Coefficient Between Total Quadriceps Muscle Thickness and End-Expiratory Diaphragm Thickness Measured by Ultrasonography (time frame: At ICU admission (baseline); 24-48 hours after intubation; and immediately before planned extubation.). 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 6 Oct 2026.