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CLEAR Model for Predicting Ventilatory Liberation in Severe COPD

Recruitingn/aAges 40 Years - anyAllAssiut University
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In plain words

What the trial is, and whether it could suit you

This prospective observational cohort study aims to prospectively evaluate and validate the Clinical Load, Exchange, Ability of Respiration, and Reserve (CLEAR) model for predicting sustained ventilatory liberation in patients with severe chronic obstructive pulmonary disease (COPD) receiving invasive mechanical ventilation (MV) or non-invasive ventilation (NIV). Two parallel cohorts will be studied: CLEAR-MV for patients undergoing spontaneous breathing trials (SBT) and CLEAR-NIV for patients undergoing NIV withdrawal trials. The model integrates diaphragm ultrasound evaluating diaphragm thickening fraction (DTF), ventilatory load indices including the rapid shallow breathing index (RSBI) or Clinical Load Index (CLI), gas exchange parameters including Potential of Hydrogen (pH), partial pressure of carbon dioxide (PaCOโ‚‚), and its change over time (ฮ”PaCOโ‚‚) combined as the Gas Exchange In

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ40 years * Confirmed or clinically diagnosed chronic obstructive pulmonary disease (COPD) based on prior spirometry or consistent clinical history * Admission to the intensive care unit (ICU) with acute respiratory failure requiring ventilatory support * Receiving either: Invasive mechanical ventilation (MV), or Non-invasive ventilation (NIV) -Considered clinically ready for ventilatory withdrawal: Undergoing spontaneous breathing trial (SBT) in the MV cohort Undergoing structured withdrawal or low-support trial in the NIV cohort Exclusion Criteria: * Age \<40 years * Primary diagnosis other than COPD driving respiratory failure (e.g., isolated pneumonia, cardiogenic pulmonary edema without COPD exacerbation) * Known neuromuscular disease affecting respiratory muscle function * Significant chest wall deformity or restrictive thoracic disorder affecting ventilatory mechanics * Presence of tracheostomy at baseline * Hemodynamic instability requiring high-dose vasopressors at the time of assessment * Inability to perform a diaphragm or muscle ultrasound (e.g., poor acoustic window, extensive dressings) * Reduced level of consciousness precluding valid clinical assessment (outside expected NIV cohort context) * Refusal of consent by patient or legal representative
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What it tests

  • Not listed
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Where

1 site
Assuit Univeristy
Asyut, Egypt
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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