CLEAR model to predict when people with severe COPD can be taken off ventilatory support

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.