CLEAR model to predict when people with severe COPD can be taken off ventilatory support
Prospective Development and Validation of the CLEAR Model for Predicting Ventilatory Liberation in Severe Chronic Obstructive Pulmonary Disease: A Cohort Study
This project will see if the CLEAR model can predict which adults with severe COPD on invasive or non‑invasive ventilation can be safely taken off ventilatory support.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Assiut University Academic / other |
| Locations | 1 site (Asyut, Assuit Egypt) |
| Trial ID | NCT07579052 on ClinicalTrials.gov |
What this trial studies
This is a prospective, dual‑cohort observational study that develops and internally validates the prespecified CLEAR model to predict sustained liberation from ventilatory support in severe COPD. Two parallel cohorts are enrolled: CLEAR‑MV for patients undergoing spontaneous breathing trials on invasive mechanical ventilation and CLEAR‑NIV for patients undergoing structured withdrawal or low‑support trials on non‑invasive ventilation. The model combines diaphragm ultrasound (diaphragm thickening fraction), ventilatory load indices (RSBI or CLI), gas exchange metrics summarized as a Gas Exchange Index, and peripheral muscle reserve (rectus femoris and vastus intermedius). Parameter estimation follows a locked model structure defined before outcome analysis, with no data-driven variable selection, and performance will be validated in an independent cohort.
Who should consider this trial
Good fit: Adults aged 40 or older with confirmed or clinically diagnosed COPD admitted to the ICU and receiving invasive or non‑invasive ventilation who are judged ready for a spontaneous breathing or ventilatory withdrawal trial are ideal candidates.
Not a fit: Patients younger than 40, those whose respiratory failure is driven primarily by a non‑COPD diagnosis, or those with neuromuscular disease, significant chest wall restriction, an existing tracheostomy, or hemodynamic instability are excluded and unlikely to benefit from this model.
Why it matters
Potential benefit: If successful, the CLEAR model could help clinicians identify patients who can be safely liberated from ventilatory support sooner, potentially reducing ICU time and ventilation‑related complications.
How similar studies have performed: Previous work using diaphragm ultrasound, RSBI, and gas exchange measures has shown promise for predicting weaning outcomes, but the CLEAR model's combined, prespecified framework is novel and requires prospective validation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥40 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
Where this trial is running
Asyut, Assuit Egypt
- Assuit Univeristy — Asyut, Assuit Egypt, Egypt (Recruiting)
Study contacts
- Principal investigator: Ahmad M. Shaddad, MD — Assiut University
- Study coordinator: Ahmad M. Shaddad, MD
- Email: shaddad_ahmad@aun.edu.eg
- Phone: +201111171930
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.