Ultrasound Evaluation of Respiratory Muscles During Mechanical Ventilation Weaning in ICU Patients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBursa Sevket Yilmaz Training and Research Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention (observational study)

    Other intervention

    This 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

150 Participants
are divided into 1 treatment group
Group A: Pneumonia ICU Patients on Invasive Mechanical Ventilation1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From Measurement Day 0 until ICU discharge, up to 72 hours after extubation

Secondary outcomes

1

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).

Time frame
From the onset of meaningful spontaneous breathing effort (first day with Richmond Agitation-Sedation Scale ≥ -3) until extubation, tracheostomy, or ICU death, assessed up to 28 days.
2

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).

Time frame
From the onset of meaningful spontaneous breathing effort (first day with Richmond Agitation-Sedation Scale ≥ -3) until extubation, tracheostomy, or ICU death, assessed up to 28 days.
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).

Time frame
From the onset of meaningful spontaneous breathing effort (first day with Richmond Agitation-Sedation Scale ≥ -3) until extubation, tracheostomy, or ICU death, assessed up to 28 days.
4

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.

Time frame
From the onset of meaningful spontaneous breathing effort (first day with RASS ≥ -3) until the first occurrence of extubation, tracheostomy, or ICU death, whichever occurs first, assessed up to 28 days.

Other outcomes

Sponsors and contacts

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