Menu
Not yet recruiting NCT07702422

The Accuracy of Combined Parasternal Intercostal Muscle Thickening Fraction and Diaphragmatic Excursion in Predicting Failure of Libration From Mechanical Ventilation

Observational Liberation From Mechanical Ventilation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Liberation From Mechanical Ventilation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Accuracy of Combined Parasternal Intercostal Muscle Thickening Fraction and Diaphragmatic Excursion in Predicting Failure of Libration From Mechanical Ventilation: A Prospective Cohort Study.

Overview

Approximately 20% of patients in the intensive care unit (ICU) requiring mechanical ventilation (MV) experience difficulty and prolonged weaning. Early spontaneous breathing trials (SBT) and timely extubation are essential to avoid complications such as diaphragmatic dysfunction, ventilator-associated pneumonia, and airway trauma. Mechanical ventilation is a vital supportive therapy in critical care. However, both delayed weaning and premature discontinuation are associated with poor outcomes and prolonged ICU stay. Prolonged MV may lead to complications including respiratory muscle dysfunction, ventilator-associated lung injury, and increased healthcare costs, emphasizing the importance of optimal timing of weaning. Ultrasonography (US) has emerged as a rapid, non-invasive bedside tool for real-time assessment of respiratory muscle function. It allows evaluation of muscle thickness and contractility, aiding in the detection of diaphragmatic dysfunction. In cases of diaphragmatic impairment, accessory respiratory muscles, particularly the parasternal intercostal muscles, play a compensatory role. Measurement of parasternal intercostal muscle thickness fraction (PICTF%) has been proposed as a predictor of weaning failure. Additionally, composite indices such as the rapid shallow breathing index (RSBI) and compliance, rate, oxygenation, and pressure (CROP) index are widely used to assess weaning readiness. A recently proposed composite index combining PICTF (\>9%) and diaphragmatic excursion (\<15 mm) demonstrated high predictive value for failure of non-invasive ventilation. Therefore, the present study aims to evaluate the effectiveness of this novel composite index in predicting weaning failure in mechanically ventilated patients.

Primary outcome measures

  • Ability of a combined PICTF% and diaphragmatic excursion to predict weaning failure . [Time frame: 5minutes after spontaneous breathing trail and after 5minutes of spontaneous breathing trail]
Secondary outcome measures (1)
  • • Difference between PICTF % at 5 and 60 min OF SBT. • RSBI at 5and 60 min of SBT. • Correlation between PICTF% and RSBI Diaphragmatic excursion [Time frame: at 5 mintues of spontanous breathing trail and at 60 minutes]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years old.
  • Both sexes.
  • Patients who have been mechanically ventilated for more than 48 h.

Exclusion criteria

  • All the patients with difficulty in obtaining an appropriate ultrasound window (diaphragmatic paralysis/injury, ascites, thoracotomy, pneumothorax, pleural effusion, flail chest, and rib fractures).
  • Neuromuscular diseases.
  • Severe head injury.
  • Pregnant and lactating women.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07702422 · md-461-2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗