Actively Recruiting
CLEAR Model for Predicting Ventilatory Liberation in Severe COPD
Led by Assiut University · Updated on 2026-05-11
400
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 (PaCO₂), and its change over time (ΔPaCO₂) combined as the Gas Exchange Index (GEI), and peripheral muscle reserve assessing rectus femoris (RF) and vastus intermedius (VI) thickness. The primary outcome is successful liberation from ventilatory support within 72 hours. Secondary outcomes include ventilatory failure within 7 days, ventilator- or NIV-free days at 28 days, and time-fixed 90-day clinical outcomes including all-cause mortality, sustained ventilatory independence, and rehospitalization for respiratory failure. Model performance will be evaluated using discrimination (area under the receiver operating characteristic curve), calibration (calibration intercept and slope), and clinical utility (decision curve analysis and net benefit) and compared with prespecified established ventilatory indices, including the Rapid Shallow Breathing Index (RSBI) and Integrative Weaning Index (IWI) in the invasive mechanical ventilation cohort, and the Heart rate, Acidosis, Consciousness, Oxygenation, and Respiratory rate (HACOR) score and the ratio of peripheral oxygen saturation to fraction of inspired oxygen divided by respiratory rate (ROX) index in the non-invasive ventilation cohort.
CONDITIONS
Official Title
CLEAR Model for Predicting Ventilatory Liberation in Severe COPD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40 years or older
- 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 invasive mechanical ventilation (MV) or non-invasive ventilation (NIV)
- Considered clinically ready for ventilatory withdrawal: Undergoing spontaneous breathing trial (SBT) in the MV cohort or undergoing structured withdrawal or low-support trial in the NIV cohort
You will not qualify if you...
- Age younger than 40 years
- Primary diagnosis other than COPD causing 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 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Assuit Univeristy
Asyut, Assuit Egypt, Egypt, 71515
Actively Recruiting
Research Team
A
Ahmad M. Shaddad, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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