About this trial
Patients with pneumonia who require invasive mechanical ventilation in the intensive care unit (ICU) often experience difficulties during the process of being separated from the breathing machine (weaning). Failure of weaning is associated with longer ventilation duration, prolonged ICU stay, and increased risk of complications and death. Therefore, simple and reliable bedside tools are needed to better understand respiratory muscle function and to help predict weaning outcomes.
This prospective, observational, single-center study aims to evaluate respiratory muscle function using bedside ultrasound in adult ICU patients with pneumonia receiving invasive mechanical ventilation. The diaphragm, parasternal intercostal muscles, and anterior scalene muscles will be assessed using ultrasound during the weaning process. Measurements will be performed serially, starting from the first day when patients demonstrate meaningful spontaneous breathing effort and continuing until successful extubation, tracheostomy, or ICU mortality.
Ultrasound measurements of muscle thickness and thickening fraction will be analyzed in relation to weaning outcomes. In addition, ventilator parameters and commonly used weaning indices will be recorded at the time of each ultrasound assessment. The findings of this study are expected to improve understanding of respiratory muscle involvement during weaning and may contribute to earlier identification of patients at risk of weaning failure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Admission to the intensive care unit with a diagnosis of pneumonia
Receiving invasive mechanical ventilation via endotracheal intubation
Expected to undergo a weaning process from mechanical ventilation
Disqualifiers
Known neuromuscular disease affecting respiratory muscles
High cervical spinal cord injury
History of major neck, thoracic, or diaphragmatic surgery
Acute thoracic trauma or pneumothorax
Trial population
The study population consists of adult patients aged 18 years and older who are admitted to the intensive care unit with pneumonia and require invasive mechanical ventilation via endotracheal intubation. Patients are followed prospectively during the weaning process from mechanical ventilation and undergo serial bedside ultrasonographic assessment of respiratory muscles as part of observational data collection. All patients receive standard intensive care management as determined by the treating clinical team.
Trial design
Cohort
Prospective
Treatments tested in this trial
No intervention (observational study)
Other interventionThis is an observational study with no assigned therapeutic intervention. Serial ultrasonographic assessments of respiratory muscles are performed for observational and data collection purposes only, and all clinical care and weaning decisions are made by the treating intensive care unit team according to standard practice.
Treatment groups
Trial outcomes
Primary outcomes
Weaning Failure
Weaning failure is defined as the need for reintubation within 72 hours after planned extubation, requirement for tracheostomy, or death occurring in the intensive care unit before successful liberation from invasive mechanical ventilation.
Secondary outcomes
Diaphragm Thickening Fraction (TFdi)
Diaphragm thickening fraction calculated from end-expiratory and end-inspiratory diaphragm thickness measurements obtained by bedside ultrasound on days with meaningful spontaneous breathing effort (RASS ≥ -3).
Parasternal Intercostal Muscle Thickening Fraction (TFic)
Parasternal intercostal muscle thickening fraction measured by ultrasound at the right second and third intercostal spaces on days with adequate spontaneous breathing effort (RASS ≥ -3).
Anterior Scalene Muscle Thickening Fraction (STF)
Anterior scalene muscle thickening fraction assessed by bedside ultrasound at the C6 level on days with meaningful spontaneous breathing effort (RASS ≥ -3).
Respiratory Drive and Weaning Indices
Commonly used weaning and respiratory drive parameters including P0.1, negative inspiratory force (NIF), rapid shallow breathing index (RSBI), and CROP index recorded concurrently with ultrasound assessments when available.
Sponsors and contacts
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