NCT05928845

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
2.2 years until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2026

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

5 months

First QC Date

June 23, 2023

Last Update Submit

June 19, 2025

Conditions

Keywords

sarcopeniaintensive careultrasonography

Outcome Measures

Primary Outcomes (1)

  • Muscle thickness

    Rectus femoris and Sternocleidomastoideus muscle thickness change when compared to the value measured at admission to the intensive care unit.

    1 week

Secondary Outcomes (2)

  • Nutrition regime

    1week

  • Nutrition Scores

    Day 1

Study Arms (1)

Muscle thickness measurement

Rectus femoris and sternocleidomastoideus muscle thickness will be measured via ultrasonography

Diagnostic Test: Muscle thickness measurement

Interventions

Rectus femoris and sternocleidomastoideus muscle thickness will be measured via ultrasonography in admission and on 7th day of admission

Muscle thickness measurement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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

You may qualify if:

  • Patients who are expected to be followed up in the intensive care unit for at least 1 week
  • Patients over 18 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tekirdag Namik Kemal University

Tekirdağ, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 27376823BACKGROUND
  • 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.

    PMID: 31029040BACKGROUND

Related Links

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Onur Baran, Asst. Prof.

    Department of Anesthesiology and Reanimation, Tekirdağ Namık Kemal University, Tekirdağ, Turkey

    STUDY DIRECTOR
  • Ayhan Şahin, Asst. Prof.

    Department of Anesthesiology and Reanimation, Tekirdağ Namık Kemal University, Tekirdağ, Turkey

    PRINCIPAL INVESTIGATOR
  • Cavidan Arar, Prof.

    Department of Anesthesiology and Reanimation, Tekirdağ Namık Kemal University, Tekirdağ, Turkey

    STUDY CHAIR

Central Study Contacts

Onur Baran, Asst. Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

June 23, 2023

First Posted

July 3, 2023

Study Start

September 1, 2025

Primary Completion

February 1, 2026

Study Completion

February 15, 2026

Last Updated

June 25, 2025

Record last verified: 2025-06

Locations