- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05928845
Sternocleidomastoid Thickness in Sarcopenia
Could Changes in Sternocleidomastoid Muscle Thickness be a Predictor of Sarcopenia in Intensive Care Patients?
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Onur Baran, Asst. Prof.
- Phone Number: 05393422582
- Email: dronurbaran@hotmail.com
Study Locations
-
-
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Tekirdağ, Turkey
- Recruiting
- Tekirdag Namik Kemal University
-
Contact:
- Onur Baran, Asst. Prof.
- Phone Number: +905393422582
- Email: dronurbaran@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients who are expected to be followed up in the intensive care unit for at least 1 week
- Patients over 18 years old
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Muscle thickness measurement
Rectus femoris and sternocleidomastoideus muscle thickness will be measured via ultrasonography
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Rectus femoris and sternocleidomastoideus muscle thickness will be measured via ultrasonography in admission and on 7th day of admission
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nutrition regime
Time Frame: 1week
|
Nutrition regimes, calorie and protein intake during admission will be saved.
|
1week
|
Nutrition Scores
Time Frame: Day 1
|
NRS 2002, NUTRIC scores will be calculated in admission
|
Day 1
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Onur Baran, Asst. Prof., Department of Anesthesiology and Reanimation, Tekirdağ Namık Kemal University, Tekirdağ, Turkey
- Principal Investigator: Ayhan Şahin, Asst. Prof., Department of Anesthesiology and Reanimation, Tekirdağ Namık Kemal University, Tekirdağ, Turkey
- Study Chair: Cavidan Arar, Prof., Department of Anesthesiology and Reanimation, Tekirdağ Namık Kemal University, Tekirdağ, Turkey
Publications and helpful links
General 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.
- Rustani 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022.67.04.17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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