Ventilator WeaningNCT07844421
Comparison of Sarcopenia Index, Diaphragm Ultrasonography, and Traditional Weaning Parameters in Predicting Successful Weaning From Mechanical Ventilation
An observational study of Ventilator Weaning and Sarcopenia, run by Kocaeli City Hospital.
Trial summary
This study investigates whether the Sarcopenia Index (SI = serum creatinine/cystatin C × 100), a simple biomarker derived from routine blood tests, can predict weaning success in critically ill patients undergoing invasive mechanical ventilation in the intensive care unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Weaning, Sarcopenia, Diaphragm Ultrasonography
- What is being tested?
- sarcopenia index, diaphragma ultrasound and parameters of mechanical ventilation (MV)
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2026to 15 Dec 2027
- 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: Adult patients admitted to the intensive care unit at Kocaeli City Hospital who require invasive mechanical ventilation for at least 24 hours and undergo a spontaneous breathing trial for weaning.
Who may be able to join
- Age 18 years and older
- Received invasive mechanical ventilation for at least 24 hours
- Weaned from invasive mechanical ventilation via a spontaneous breathing trial (SBT) after meeting weaning criteria
- Patients on at least 24-hour invasive mechanical ventilator support receiving antibiotherapy, in whom serum cystatin C was measured
Who cannot join
- Pregnancy
- Neuromuscular disease
- High cervical spinal cord injury
- Terminal-stage malignancy
- Chronic home mechanical ventilator dependency
- Diaphragmatic paralysis
Show all 9Show fewer
- Renal replacement therapy
- Chronic kidney disease on a regular dialysis program
- Significant renal function fluctuation within 48 hours prior to weaning
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
This study investigates whether the Sarcopenia Index (SI = serum creatinine/cystatin C × 100), a simple biomarker derived from routine blood tests, can predict weaning success in critically ill patients undergoing invasive mechanical ventilation in the intensive care unit. SI will be measured at the spontaneous breathing trial (SBT), and its predictive value will be compared with diaphragm ultrasound parameters - diaphragm thickening fraction (DTF) and diaphragm excursion (DE) - as well as other established weaning parameters. The goal is to determine whether SI can serve as an accessible, low-cost alternative or complement to ultrasound-based assessment in predicting successful liberation from mechanical ventilation, and to establish a population-specific SI cutoff value for this setting.
Read the detailed description
This study will enroll adult patients undergoing invasive mechanical ventilation in the ICU. Serum creatinine and cystatin C will be measured at the time of the spontaneous breathing trial (SBT) to calculate SI . Diaphragm ultrasound parameters (DTF and DE) will be obtained at the SBT, along with other standard weaning parameters (e.g., rapid shallow breathing index, and other clinically used indices). Weaning success will be defined as the absence of reintubation or need for ventilatory support within 48-72 hours after extubation.
The primary aim is to evaluate the diagnostic accuracy of SI, alone and in combination with diaphragm ultrasound parameters, in predicting weaning success using receiver operating characteristic (ROC) curve analysis, and to derive a population-specific SI cutoff value for this setting. Secondary aims include comparing SI's predictive performance to established weaning parameters and assessing correlations between SI and diaphragm ultrasound measurements. If validated, SI could offer clinicians a low-cost, widely available, and less operator-dependent adjunct or alternative to ultrasound-based assessment of weaning readiness.
- Conditions
- Ventilator Weaning, Sarcopenia, Diaphragm Ultrasonography
- Being tested
- sarcopenia index, diaphragma ultrasound, parameters of mechanical ventilation (MV)
- Keywords
- mechanical ventilation, sarcopenia index, critical care, weaning
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sarcopenia indexOther
A calculated biomarker derived from routinely measured serum creatinine and serum cystatin C values [(creatinine/cystatin C) × 100], obtained at the time of the spontaneous breathing trial.
diaphragma ultrasoundOther
Non-invasive, point-of-care bedside ultrasonography of the diaphragm performed at the time of the spontaneous breathing trial using a linear high-frequency probe (3-14 MHz) at the 8th-10th intercostal space between the anterior and mid-axillary lines. Diaphragm excursion (DE) is measured with a curvilinear probe (1.3-5.7 MHz) in M-mode. End-expiratory and end-inspiratory diaphragm thickness are measured, and the diaphragm thickening fraction (DTF) is calculated as [(inspiratory thickness - expiratory thickness) / expiratory thickness] × 100. This is a diagnostic imaging assessment, not a therapeutic intervention, and involves no ionizing radiation or additional risk to the patient.
parameters of mechanical ventilation (MV)Other
Standard bedside weaning parameters recorded by the investigator at the time of the spontaneous breathing trial: Rapid Shallow Breathing Index (RSBI, respiratory rate/tidal volume ratio), Negative Inspiratory Force (NIF/PImax, maximal inspiratory pressure), and Airway Occlusion Pressure at 0.1 seconds (P0.1). These are routine, non-invasive respiratory mechanics measurements obtained as part of standard weaning assessment, with no additional risk or intervention beyond usual ICU care.
| Study group | Role | What they receive |
|---|---|---|
| Weaning Success | Patients who met weaning criteria and were successfully extubated following a spontaneous breathing trial (SBT), without reintubation or need for non-invasive mechanical ventilation (NIMV) within 48 hours post-extubation.
In this group, diaphragm ultrasonography (diaphragm excursion, end-expiratory and end-inspiratory diaphragm thickness, diaphragm thickening fraction), classical weaning parameters (RSBI, NIF, P0.1), and the Sarcopenia Index (serum creatinine/serum cystatin C × 100) were recorded at the time of the SBT. Receives: Other: sarcopenia index; Other: diaphragma ultrasound; Other: parameters of mechanical ventilation (MV) | |
| Weaning Failure | Patients who, despite meeting weaning criteria and undergoing an SBT, required reintubation or new NIMV support within 48 hours post-extubation, classified as unsuccessful weaning. The same diaphragm ultrasonography parameters, classical weaning parameters, and Sarcopenia Index measurements were recorded at the time of the SBT for comparison with the Weaning Success group. Receives: Other: sarcopenia index; Other: diaphragma ultrasound; Other: parameters of mechanical ventilation (MV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive Value of the Sarcopenia Index for Predicting Weaning Success
Area under the ROC curve (AUC), sensitivity, and specificity of the Sarcopenia Index (serum creatinine/serum cystatin C × 100) in predicting successful weaning from invasive mechanical ventilation.
Measured: Through study completion, an avarage of 1 year
Secondary outcomes (1)
Association Between Sarcopenia Index and Reintubation
Comparison of Sarcopenia Index values (serum creatinine/serum cystatin C × 100) measured at the spontaneous breathing trial between patients who required reintubation or new non-invasive mechanical ventilation (NIMV) support and those who did not, within 48 hours post-extubation.
Measured: Within 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 posted28 Sep 2026
- Study start15 Nov 2026 (estimated)
- Primary completion15 Nov 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Ventilator WeaningStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hasan Berk Gönülalan, Kocaeli City Hospital
- Investigators
- Ahmet YÜKSEK, Associate Professor Dr., Principal investigator, Kocaeli City HospitalAdnan ATA, Medical Doctor, Study director, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07844421
- Sponsor's protocol ID
- hbg58
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No formal plan for sharing individual participant data (IPD) with other researchers has been established at this time. Data will be reported in aggregate form in accordance with the study's ethics committee approval and institutional data protection policies.
Publications
Kilaru D, Panebianco N, Baston C. Diaphragm Ultrasound in Weaning From Mechanical Ventilation. Chest. 2021 Mar;159(3):1166-1172. doi: 10.1016/j.chest.2020.12.003. Epub 2020 Dec 10.
PubMed 33309837Goligher EC, Dres M, Fan E, Rubenfeld GD, Scales DC, Herridge MS, Vorona S, Sklar MC, Rittayamai N, Lanys A, Murray A, Brace D, Urrea C, Reid WD, Tomlinson G, Slutsky AS, Kavanagh BP, Brochard LJ, Ferguson ND. Mechanical Ventilation-induced Diaphragm Atrophy Strongly Impacts Clinical Outcomes. Am J Respir Crit Care Med. 2018 Jan 15;197(2):204-213. doi: 10.1164/rccm.201703-0536OC.
PubMed 28930478Zarco-Martin MT, Andreo-Lopez MC, Yagui-Beltran MS, Fernandez-Soto ML. Sarcopenia in amyotrophic lateral sclerosis: a key predictor of respiratory dysfunction and disease progression. Front Nutr. 2026 Mar 2;13:1713253. doi: 10.3389/fnut.2026.1713253. eCollection 2026.
PubMed 41847237Kashani KB, Frazee EN, Kukralova L, Sarvottam K, Herasevich V, Young PM, Kashyap R, Lieske JC. Evaluating Muscle Mass by Using Markers of Kidney Function: Development of the Sarcopenia Index. Crit Care Med. 2017 Jan;45(1):e23-e29. doi: 10.1097/CCM.0000000000002013.
PubMed 27611976Zhao X, Su R, Hu R, Chen Y, Xu X, Yuan Y, Zhang J, Zhang W, Yang Y, Chen M, Li D, Wu B, Huang D, Wu D. Sarcopenia index as a predictor of clinical outcomes among older adult patients with acute exacerbation of chronic obstructive pulmonary disease: a cross-sectional study. BMC Geriatr. 2023 Feb 11;23(1):89. doi: 10.1186/s12877-023-03784-7.
PubMed 36774462Xie D, Xiao Y, Li X, Sun B, Feng J, Jia J, Li J, Wang Y, He F, Liu L. Mechanosensitive Piezo1 Channels Mediate Diaphragm Fibrosis Induced by Prolonged Mechanical Ventilation. J Cachexia Sarcopenia Muscle. 2025 Dec;16(6):e70136. doi: 10.1002/jcsm.70136.
PubMed 41332397
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sarcopenia Index, Diaphragm Ultrasonography, and Traditional Weaning Parameters in Predicting Successful Weaning From Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT07844421
- Acronym / sponsor ID
- hbg58
- Conditions
- Ventilator Weaning, Sarcopenia, Diaphragm Ultrasonography
- Keywords
- mechanical ventilation, sarcopenia index, critical care, weaning
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kocaeli City HospitalOther government
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 15 Nov 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 28 Sep 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.
This study investigates whether the Sarcopenia Index (SI = serum creatinine/cystatin C × 100), a simple biomarker derived from routine blood tests, can predict weaning success in critically ill patients undergoing invasive mechanical ventilation in the intensive care unit. SI will be measured at the spontaneous breathing trial (SBT), and its predictive value will be compared with diaphragm ultrasound parameters - diaphragm thickening fraction (DTF) and diaphragm excursion (DE) - as well as other established weaning parameters. The goal is to determine whether SI can serve as an accessible, low-cost alternative or complement to ultrasound-based assessment in predicting successful liberation from mechanical ventilation, and to establish a population-specific SI cutoff value for this setting.
Detailed description
This study will enroll adult patients undergoing invasive mechanical ventilation in the ICU. Serum creatinine and cystatin C will be measured at the time of the spontaneous breathing trial (SBT) to calculate SI . Diaphragm ultrasound parameters (DTF and DE) will be obtained at the SBT, along with other standard weaning parameters (e.g., rapid shallow breathing index, and other clinically used indices). Weaning success will be defined as the absence of reintubation or need for ventilatory support within 48-72 hours after extubation.
The primary aim is to evaluate the diagnostic accuracy of SI, alone and in combination with diaphragm ultrasound parameters, in predicting weaning success using receiver operating characteristic (ROC) curve analysis, and to derive a population-specific SI cutoff value for this setting. Secondary aims include comparing SI's predictive performance to established weaning parameters and assessing correlations between SI and diaphragm ultrasound measurements. If validated, SI could offer clinicians a low-cost, widely available, and less operator-dependent adjunct or alternative to ultrasound-based assessment of weaning readiness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weaning Success | – | Other: sarcopenia index, Other: diaphragma ultrasound, Other: parameters of mechanical ventilation (MV)Patients who met weaning criteria and were successfully extubated following a spontaneous breathing trial (SBT), without reintubation or need for non-invasive mechanical ventilation (NIMV) within 48 hours post-extubation. In this group, diaphragm ultrasonography (diaphragm excursion, end-expiratory and end-inspiratory diaphragm thickness, diaphragm thickening fraction), classical weaning parameters (RSBI, NIF, P0.1), and the Sarcopenia Index (serum creatinine/serum cystatin C × 100) were recorded at the time of the SBT. |
| Weaning Failure | – | Other: sarcopenia index, Other: diaphragma ultrasound, Other: parameters of mechanical ventilation (MV)Patients who, despite meeting weaning criteria and undergoing an SBT, required reintubation or new NIMV support within 48 hours post-extubation, classified as unsuccessful weaning. The same diaphragm ultrasonography parameters, classical weaning parameters, and Sarcopenia Index measurements were recorded at the time of the SBT for comparison with the Weaning Success group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to the intensive care unit at Kocaeli City Hospital who require invasive mechanical ventilation for at least 24 hours and undergo a spontaneous breathing trial for weaning.
Key inclusion criteria (4 listed)
- Age 18 years and older
- Received invasive mechanical ventilation for at least 24 hours
- Weaned from invasive mechanical ventilation via a spontaneous breathing trial (SBT) after meeting weaning criteria
- Patients on at least 24-hour invasive mechanical ventilator support receiving antibiotherapy, in whom serum cystatin C was measured
Key exclusion criteria (9 listed)
- Pregnancy
- Neuromuscular disease
- High cervical spinal cord injury
- Terminal-stage malignancy
- Chronic home mechanical ventilator dependency
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 |
|---|---|---|
| sarcopenia indexA calculated biomarker derived from routinely measured serum creatinine and serum cystatin C values [(creatinine/cystatin C) × 100], obtained at the time of the spontaneous breathing trial. | Other | Weaning Failure, Weaning Success |
| diaphragma ultrasoundNon-invasive, point-of-care bedside ultrasonography of the diaphragm performed at the time of the spontaneous breathing trial using a linear high-frequency probe (3-14 MHz) at the 8th-10th intercostal space between the anterior and mid-axillary lines. Diaphragm excursion (DE) is measured with a curvilinear probe (1.3-5.7 MHz) in M-mode. End-expiratory and end-inspiratory diaphragm thickness are measured, and the diaphragm thickening fraction (DTF) is calculated as [(inspiratory thickness - expiratory thickness) / expiratory thickness] × 100. This is a diagnostic imaging assessment, not a therapeutic intervention, and involves no ionizing radiation or additional risk to the patient. | Other | Weaning Failure, Weaning Success |
| parameters of mechanical ventilation (MV)Standard bedside weaning parameters recorded by the investigator at the time of the spontaneous breathing trial: Rapid Shallow Breathing Index (RSBI, respiratory rate/tidal volume ratio), Negative Inspiratory Force (NIF/PImax, maximal inspiratory pressure), and Airway Occlusion Pressure at 0.1 seconds (P0.1). These are routine, non-invasive respiratory mechanics measurements obtained as part of standard weaning assessment, with no additional risk or intervention beyond usual ICU care. | Other | Weaning Failure, Weaning Success |
Primary outcome
Predictive Value of the Sarcopenia Index for Predicting Weaning Success
Time frame: Through study completion, an avarage of 1 year
Area under the ROC curve (AUC), sensitivity, and specificity of the Sarcopenia Index (serum creatinine/serum cystatin C × 100) in predicting successful weaning from invasive mechanical ventilation.
1 secondary outcome
Association Between Sarcopenia Index and Reintubation
Time frame: Within 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 28 Sep 2026.
- Background: PubMed 33309837Kilaru D, Panebianco N, Baston C. Diaphragm Ultrasound in Weaning From Mechanical Ventilation. Chest. 2021 Mar;159(3):1166-1172. doi: 10.1016/j.chest.2020.12.003. Epub 2020 Dec 10.
- Background: PubMed 28930478Goligher EC, Dres M, Fan E, Rubenfeld GD, Scales DC, Herridge MS, Vorona S, Sklar MC, Rittayamai N, Lanys A, Murray A, Brace D, Urrea C, Reid WD, Tomlinson G, Slutsky AS, Kavanagh BP, Brochard LJ, Ferguson ND. Mechanical Ventilation-induced Diaphragm Atrophy Strongly Impacts Clinical Outcomes. Am J Respir Crit Care Med. 2018 Jan 15;197(2):204-213. doi: 10.1164/rccm.201703-0536OC.
- Background: PubMed 41847237Zarco-Martin MT, Andreo-Lopez MC, Yagui-Beltran MS, Fernandez-Soto ML. Sarcopenia in amyotrophic lateral sclerosis: a key predictor of respiratory dysfunction and disease progression. Front Nutr. 2026 Mar 2;13:1713253. doi: 10.3389/fnut.2026.1713253. eCollection 2026.
- Background: PubMed 27611976Kashani KB, Frazee EN, Kukralova L, Sarvottam K, Herasevich V, Young PM, Kashyap R, Lieske JC. Evaluating Muscle Mass by Using Markers of Kidney Function: Development of the Sarcopenia Index. Crit Care Med. 2017 Jan;45(1):e23-e29. doi: 10.1097/CCM.0000000000002013.
- Background: PubMed 36774462Zhao X, Su R, Hu R, Chen Y, Xu X, Yuan Y, Zhang J, Zhang W, Yang Y, Chen M, Li D, Wu B, Huang D, Wu D. Sarcopenia index as a predictor of clinical outcomes among older adult patients with acute exacerbation of chronic obstructive pulmonary disease: a cross-sectional study. BMC Geriatr. 2023 Feb 11;23(1):89. doi: 10.1186/s12877-023-03784-7.
- Background: PubMed 41332397Xie D, Xiao Y, Li X, Sun B, Feng J, Jia J, Li J, Wang Y, He F, Liu L. Mechanosensitive Piezo1 Channels Mediate Diaphragm Fibrosis Induced by Prolonged Mechanical Ventilation. J Cachexia Sarcopenia Muscle. 2025 Dec;16(6):e70136. doi: 10.1002/jcsm.70136.
- Individual participant dataSharing planned: No. No formal plan for sharing individual participant data (IPD) with other researchers has been established at this time. Data will be reported in aggregate form in accordance with the study's ethics committee approval and institutional data protection policies.
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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.
Ahmet YÜKSEK, Associate Professor Dr. principal investigator
Kocaeli City Hospital
Adnan ATA, Medical Doctor study director
Kocaeli City Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator Weaning and Sarcopenia, run by Kocaeli City Hospital.
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 9 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 28 Sep 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 Ahmet YÜKSEK, Associate Professor Dr. (+905326580351, mdayuksek@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive Value of the Sarcopenia Index for Predicting Weaning Success (time frame: Through study completion, an avarage of 1 year). 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 NCT07844421, which also lists 6 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 28 Sep 2026.