Weaning Assessment by Peripheral Muscle Ultrasonography
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTaksim Egitim ve Arastirma Hastanesi
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Being 18 years of age or older.
Having been in the intensive care unit for more than 24 hours.
Having no contraindications to undergoing an ultrasonographic assessment.
Disqualifiers
Known neuromuscular disease.
Significant motor paralysis due to cervical spinal cord injury or advanced central nervous system lesion.
Advanced-stage primary muscle disease directly affecting muscle mass.
Thoracic wall deformity or a condition technically preventing assessment of the diaphragm.
Trial population
Patient group aged 18 and older with an intensive care stay exceeding 24 hours.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Ultrasonography of peripheral muscle (rectus femoris or vastus intermedius)
Diagnostic testThe measurement of peripheral muscle thickness by ultrasonography. Rectus femoris or vastus intermedius will be measured (Or the total of quadriceps).
Ultrasonography of diaphragma
Diagnostic testDiaphragm thickness, diaphragm thickening fraction, and, if possible, diaphragm excursion will be measured.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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. The 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. Baseline assessment will include participants regardless of intubation status. Subsequent assessments will apply to participants who are intubated and those undergoing planned extubation, respectively.
Time frame
At ICU admission (baseline); 24-48 hours after intubation; and immediately before planned extubation.Secondary outcomes
1
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. Diaphragm thickening fraction will be calculated from ultrasound measurements as: \[(end-inspiratory diaphragm thickness - end-expiratory diaphragm thickness) / end-expiratory diaphragm thickness\] × 100, and expressed as a percentage. The 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. Baseline assessment will include participants regardless of intubation status. Subsequent assessments will apply to participants who are intubated and those undergoing planned extubation, respectively.
Time frame
At ICU admission (baseline); 24-48 hours after intubation; and immediately before planned extubation.2
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. For each participant, percentage change from the ICU admission measurement will be calculated as: \[(follow-up thickness - baseline thickness) / baseline thickness\] × 100. Negative values indicate a reduction in muscle thickness. The 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 (%).
Time frame
From ICU admission (baseline) to 24-48 hours after intubation; and from ICU admission (baseline) to immediately before planned extubation.3
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. For each participant, percentage change from the ICU admission measurement will be calculated as: \[(follow-up thickness - baseline thickness) / baseline thickness\] × 100. Negative values indicate a reduction in diaphragm thickness. The 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 (%).
Time frame
From ICU admission (baseline) to 24-48 hours after intubation; and from ICU admission (baseline) to immediately before planned extubation.4
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. Extubation 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.
Time frame
From the first planned extubation through 48 hours after extubation.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: