SarcopeniaNCT05928845
Sternocleidomastoid Thickness in Sarcopenia
An observational study of Sarcopenia, run by Namik Kemal University at 1 site in Turkey (Türkiye).
Trial summary
In order to prevent sarcopenia in intensive care patients and to guide nutritional therapy, evaluation of muscle thickness with ultrasonography is a modern, simple and non-invasive procedure routinely performed by Anesthesiology and Reanimation specialists. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Muscle thickness measurement
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 15 Sep 2026
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
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 who are expected to be followed up in the intensive care unit for at least 1 week in a tertiary university research and education hospital based 11 bed ICU
Who may be able to join
- Patients who are expected to be followed up in the intensive care unit for at least 1 week
- Patients over 18 years old
Who cannot join
- Patients under 18 years of age
- Head-neck, femur trauma patients
- Those with a diagnosis of primary neuromuscular disease
- Those who have a condition that prevents imaging in the body parts where ultrasonography is planned
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Could Changes in Sternocleidomastoid Muscle Thickness be a Predictor of Sarcopenia in Intensive Care Patients?
In order to prevent sarcopenia in intensive care patients and to guide nutritional therapy, evaluation of muscle thickness with ultrasonography is a modern, simple and non-invasive procedure routinely performed by Anesthesiology and Reanimation specialists. Sarcopenia in intensive care patients has been demonstrated in many studies. It has been studied that routine examination of changes in rectus femoris muscle thickness by ultrasonography is a predictor of sarcopenia. However, the muscles in the neck region, such as the sternocleidomastoid muscle, which are easy to examine, have not been studied very well. There is no study in the literature with the sternocleidomastoid muscle. For this reason, we decided to examine the relationship of sternocleidomastoid muscle thickness with patient characteristics, treatments, feeding route and type, feeding time, length of stay in intensive care unit, as in routine measurements of rectus femoris muscle thickness by ultrasonography.
Read the detailed description
Sarcopenia is an important clinical condition, characterized by a decrease in muscle mass and function that increases with age, especially in elderly patients. Studies have shown that sarcopenic patients have higher morbidity and mortality rates than non-sarcopenic patients. Along with the increased risk of muscle wasting in intensive care patients, there is an increase in both hospital mortality rates and the frequency of post-hospital mobilization problems.
Intensive care patients are a group of patients who are very prone to protein-energy malnutrition, and this leads to complications such as nosocomial infection and multiple organ failure, leading to prolongation of the stay in the intensive care unit, as well as an increase in morbidity and mortality. Therefore, nutritional support is a routine requirement of intensive care treatment and has a vital role in the prevention and treatment of nutritional deficiencies in intensive care patients.
The first point that should be evaluated in terms of the follow-up of a patient on whom nutritional support is maintained is to know for what reason, when, and what kind of treatment is planned in terms of quality and quantity. This is a starting point for monitoring. Knowing the patient's clinical and laboratory values when nutritional therapy is initiated allows the evaluation of how these data have changed during follow-up. The purpose of assessment of nutritional status is to identify the type and degree of malnutrition in order to make a rational treatment approach. However, there is no test that is both sensitive and specific to determine malnutrition in intensive care patients.
- Conditions
- Sarcopenia
- Being tested
- Muscle thickness measurement
- Keywords
- sarcopenia, intensive care, ultrasonography
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle thickness measurementDiagnostic test
Rectus femoris and sternocleidomastoideus muscle thickness will be measured via ultrasonography in admission and on 7th day of admission
| Study group | Role | What they receive |
|---|---|---|
| Muscle thickness measurement | Rectus femoris and sternocleidomastoideus muscle thickness will be measured via ultrasonography Receives: Diagnostic Test: Muscle thickness measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle thickness
Rectus femoris and Sternocleidomastoideus muscle thickness change when compared to the value measured at admission to the intensive care unit.
Measured: 1 week
Secondary outcomes (2)
Nutrition regime
Nutrition regimes, calorie and protein intake during admission will be saved.
Measured: 1week
Nutrition Scores
NRS 2002, NUTRIC scores will be calculated in admission
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Sep 2025
- Primary completion1 Sep 2026
- Study completion15 Sep 2026
Why it stopped: Due to an overly detailed methodology and strict inclusion/exclusion criteria, patient recruitment was insufficient (poor accrual), leading to early termination of the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies 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
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Namik Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Baran, Namik Kemal University
- Investigators
- Onur Baran, Asst. Prof., Study director, Department of Anesthesiology and Reanimation, Tekirdağ Namık Kemal University, Tekirdağ, TurkeyAyhan Şahin, Asst. Prof., Principal investigator, Department of Anesthesiology and Reanimation, Tekirdağ Namık Kemal University, Tekirdağ, TurkeyCavidan Arar, Prof., Study chair, Department of Anesthesiology and Reanimation, Tekirdağ Namık Kemal University, Tekirdağ, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928845
- Sponsor's protocol ID
- 2022.67.04.17
- Status last verified
- Sep 2026
- First submitted
- 23 Jun 2023
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kizilarslanoglu MC, Kuyumcu ME, Yesil Y, Halil M. Sarcopenia in critically ill patients. J Anesth. 2016 Oct;30(5):884-90. doi: 10.1007/s00540-016-2211-4. Epub 2016 Jul 4.
PubMed 27376823Rustani K, Kundisova L, Capecchi PL, Nante N, Bicchi M. Ultrasound measurement of rectus femoris muscle thickness as a quick screening test for sarcopenia assessment. Arch Gerontol Geriatr. 2019 Jul-Aug;83:151-154. doi: 10.1016/j.archger.2019.03.021. Epub 2019 Mar 27.
PubMed 31029040
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Could Changes in Sternocleidomastoid Muscle Thickness be a Predictor of Sarcopenia in Intensive Care Patients?
- ClinicalTrials.gov ID
- NCT05928845
- Acronym / sponsor ID
- 2022.67.04.17
- Conditions
- Sarcopenia
- Keywords
- sarcopenia, intensive care, ultrasonography
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to an overly detailed methodology and strict inclusion/exclusion criteria, patient recruitment was insufficient (poor accrual), leading to early termination of the study.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Namik Kemal UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 15 Sep 2026 (actual)
- First posted
- 3 Jul 2023 (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 order to prevent sarcopenia in intensive care patients and to guide nutritional therapy, evaluation of muscle thickness with ultrasonography is a modern, simple and non-invasive procedure routinely performed by Anesthesiology and Reanimation specialists. Sarcopenia in intensive care patients has been demonstrated in many studies. It has been studied that routine examination of changes in rectus femoris muscle thickness by ultrasonography is a predictor of sarcopenia. However, the muscles in the neck region, such as the sternocleidomastoid muscle, which are easy to examine, have not been studied very well. There is no study in the literature with the sternocleidomastoid muscle. For this reason, we decided to examine the relationship of sternocleidomastoid muscle thickness with patient characteristics, treatments, feeding route and type, feeding time, length of stay in intensive care unit, as in routine measurements of rectus femoris muscle thickness by ultrasonography.
Detailed description
Sarcopenia is an important clinical condition, characterized by a decrease in muscle mass and function that increases with age, especially in elderly patients. Studies have shown that sarcopenic patients have higher morbidity and mortality rates than non-sarcopenic patients. Along with the increased risk of muscle wasting in intensive care patients, there is an increase in both hospital mortality rates and the frequency of post-hospital mobilization problems.
Intensive care patients are a group of patients who are very prone to protein-energy malnutrition, and this leads to complications such as nosocomial infection and multiple organ failure, leading to prolongation of the stay in the intensive care unit, as well as an increase in morbidity and mortality. Therefore, nutritional support is a routine requirement of intensive care treatment and has a vital role in the prevention and treatment of nutritional deficiencies in intensive care patients.
The first point that should be evaluated in terms of the follow-up of a patient on whom nutritional support is maintained is to know for what reason, when, and what kind of treatment is planned in terms of quality and quantity. This is a starting point for monitoring. Knowing the patient's clinical and laboratory values when nutritional therapy is initiated allows the evaluation of how these data have changed during follow-up. The purpose of assessment of nutritional status is to identify the type and degree of malnutrition in order to make a rational treatment approach. However, there is no test that is both sensitive and specific to determine malnutrition in intensive care patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Muscle thickness measurement | – | Diagnostic Test: Muscle thickness measurementRectus femoris and sternocleidomastoideus muscle thickness will be measured via ultrasonography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are expected to be followed up in the intensive care unit for at least 1 week in a tertiary university research and education hospital based 11 bed ICU
Key inclusion criteria (2 listed)
- Patients who are expected to be followed up in the intensive care unit for at least 1 week
- Patients over 18 years old
Key exclusion criteria (4 listed)
- Patients under 18 years of age
- Head-neck, femur trauma patients
- Those with a diagnosis of primary neuromuscular disease
- Those who have a condition that prevents imaging in the body parts where ultrasonography is planned
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 |
|---|---|---|
| Muscle thickness measurementRectus femoris and sternocleidomastoideus muscle thickness will be measured via ultrasonography in admission and on 7th day of admission | Diagnostic test | Muscle thickness measurement |
Primary outcome
Muscle thickness
Time frame: 1 week
Rectus femoris and Sternocleidomastoideus muscle thickness change when compared to the value measured at admission to the intensive care unit.
2 secondary outcomes
Nutrition regime
Time frame: 1week
Nutrition Scores
Time frame: Day 1
Results and safety
The study was stopped early (reason given: Due to an overly detailed methodology and strict inclusion/exclusion criteria, patient recruitment was insufficient (poor accrual), leading to early termination of the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Background: PubMed 27376823Kizilarslanoglu MC, Kuyumcu ME, Yesil Y, Halil M. Sarcopenia in critically ill patients. J Anesth. 2016 Oct;30(5):884-90. doi: 10.1007/s00540-016-2211-4. Epub 2016 Jul 4.
- Background: PubMed 31029040Rustani K, Kundisova L, Capecchi PL, Nante N, Bicchi M. Ultrasound measurement of rectus femoris muscle thickness as a quick screening test for sarcopenia assessment. Arch Gerontol Geriatr. 2019 Jul-Aug;83:151-154. doi: 10.1016/j.archger.2019.03.021. Epub 2019 Mar 27.
- ReferenceLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Onur Baran, Asst. Prof. study director
Department of Anesthesiology and Reanimation, Tekirdağ Namık Kemal University, Tekirdağ, Turkey
Ayhan Şahin, Asst. Prof. principal investigator
Department of Anesthesiology and Reanimation, Tekirdağ Namık Kemal University, Tekirdağ, Turkey
Cavidan Arar, Prof. study chair
Department of Anesthesiology and Reanimation, Tekirdağ Namık Kemal University, Tekirdağ, Turkey
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 Sarcopenia, run by Namik Kemal 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 2 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: stopped early, as of the sponsor's last update on 29 Sep 2026. 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?
The study was stopped early (reason given: Due to an overly detailed methodology and strict inclusion/exclusion criteria, patient recruitment was insufficient (poor accrual), leading to early termination of the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle thickness (time frame: 1 week). 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 NCT05928845, which also lists 2 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 29 Sep 2026.