[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659208":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":35,"studyPopulation":36,"armGroups":31,"interventions":37,"overallOfficials":31,"centralContacts":45,"locations":31,"responsibleParty":51,"collaborators":31,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":31,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":31,"enrollmentInfo":64,"targetDuration":67,"studyType":68,"phases":31,"briefSummary":69,"conditions":70,"keywords":75,"overallStatus":78,"whyStopped":31,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":31},{"fullName":5,"class":6},"Taksim Egitim ve Arastirma Hastanesi","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":31},[9],{"measure":10,"description":11,"timeFrame":12},"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.\n\nThe 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.\n\nBaseline assessment will include participants regardless of intubation status. Subsequent assessments will apply to participants who are intubated and those undergoing planned extubation, respectively.","At ICU admission (baseline); 24-48 hours after intubation; and immediately before planned extubation.",[14,17,21,24,28],{"measure":15,"description":16,"timeFrame":12},"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.\n\nDiaphragm thickening fraction will be calculated from ultrasound measurements as: \\[(end-inspiratory diaphragm thickness - end-expiratory diaphragm thickness) \u002F end-expiratory diaphragm thickness\\] × 100, and expressed as a percentage.\n\nThe 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.\n\nBaseline assessment will include participants regardless of intubation status. Subsequent assessments will apply to participants who are intubated and those undergoing planned extubation, respectively.",{"measure":18,"description":19,"timeFrame":20},"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.\n\nFor each participant, percentage change from the ICU admission measurement will be calculated as: \\[(follow-up thickness - baseline thickness) \u002F baseline thickness\\] × 100. Negative values indicate a reduction in muscle thickness.\n\nThe 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 (%).","From ICU admission (baseline) to 24-48 hours after intubation; and from ICU admission (baseline) to immediately before planned extubation.",{"measure":22,"description":23,"timeFrame":20},"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.\n\nFor each participant, percentage change from the ICU admission measurement will be calculated as: \\[(follow-up thickness - baseline thickness) \u002F baseline thickness\\] × 100. Negative values indicate a reduction in diaphragm thickness.\n\nThe 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 (%).",{"measure":25,"description":26,"timeFrame":27},"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.\n\nExtubation 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.","From the first planned extubation through 48 hours after extubation.",{"measure":29,"description":30,"timeFrame":27},"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.\n\nThe 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.",null,{"allocation":31,"interventionModel":31,"interventionModelDescription":31,"primaryPurpose":31,"observationalModel":33,"timePerspective":34,"maskingInfo":31},"OTHER","PROSPECTIVE","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.\n\nIn 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\u002Fneuromuscular blockers\u002Fcorticosteroids used, nutritional method and daily protein intake, and laboratory data (albumin, CK, CRP).\n\nPeripheral 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.\n\nDiaphragm measurements will be based on diaphragm thickness, diaphragm thickening fraction, and-where possible-diaphragm excursion.\n\nParameters to be recorded regarding weaning include: RSBI, spontaneous breathing trial outcome, MIP\u002FNIF, tidal volume, respiratory rate, P0.1 (if available), extubation success or failure, occurrence of re-extubation within 48 hours, and the need for tracheostomy.","Patient group aged 18 and older with an intensive care stay exceeding 24 hours.",[38,42],{"type":39,"name":40,"description":41,"armGroupLabels":31,"otherNames":31},"DIAGNOSTIC_TEST","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).",{"type":39,"name":43,"description":44,"armGroupLabels":31,"otherNames":31},"Ultrasonography of diaphragma","Diaphragm thickness, diaphragm thickening fraction, and, if possible, diaphragm excursion will be measured.",[46],{"name":47,"role":48,"phone":49,"phoneExt":31,"email":50},"Yasemin Tekdöş Şeker Associate Professor, MD","CONTACT","+90 532 475 51 54","yasemintekdos@gmail.com",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Canberk Çetinel","Assistant researcher","100659208","weaning-assessment-by-peripheral-muscle-ultrasonography-100659208",false,"NCT07860879","Weaning Assessment by Peripheral Muscle Ultrasonography","Ultrasonographic Assessment of Peripheral Muscles and the Diaphragm in Adult Intensive Care Patients: Relation With Weaning Parameters","Inclusion Criteria:\n\n* Being 18 years of age or older.\n* Having been in the intensive care unit for more than 24 hours.\n* Having no contraindications to undergoing an ultrasonographic assessment.\n\nExclusion Criteria:\n\n* Known neuromuscular disease.\n* Significant motor paralysis due to cervical spinal cord injury or advanced central nervous system lesion.\n* Advanced-stage primary muscle disease directly affecting muscle mass.\n* Thoracic wall deformity or a condition technically preventing assessment of the diaphragm.\n* Amputation, severe peripheral trauma, or local pathology in the muscle to be measured.\n* Pregnancy.\n* Inability to obtain consent from a legal representative for participation in the study.\n* Patients with a very short life expectancy, where it is anticipated that the data collection protocol cannot be completed.","ALL","18 Years",{"count":65,"type":66},100,"ESTIMATED","1 Day","OBSERVATIONAL","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.",[71,72,73,74],"ICU Stay","Muscle Atrophy","Ultrasonography","Weaning Mechanical Ventilation",[76,77],"muscla ultrasonography","muscle atrophy","NOT_YET_RECRUITING","2026-09-30",{"date":81,"type":82},"2026-10-06","ACTUAL",{"date":84,"type":66},"2026-09-25",{"date":86,"type":66},"2027-09-25",{"name":5,"class":6}]