New model aims to take the guesswork out of ventilator weaning for COPD patients
NCT ID NCT07579052
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is developing and testing a new tool called the CLEAR model to help doctors predict when people with severe COPD can safely stop using a ventilator or non-invasive breathing support. Researchers will enroll 400 adults in the ICU and track how well the model predicts successful weaning within 72 hours. The goal is to improve decision-making and reduce the risk of breathing failure after support is removed.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could give doctors a more accurate way to decide when COPD patients can safely come off a ventilator, reducing complications and hospital stays.
- What could go wrong
- This is an early observational study, not a treatment trial. The model may not prove accurate enough to change practice, and results may not apply to all COPD patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Adult patients aged ≥40 years with confirmed or clinically diagnosed chronic obstructive pulmonary disease (COPD) admitted to the intensive care unit with acute respiratory failure requiring ventilatory support will be enrolled. Patients will be classified into two prospective cohorts according to the mode of ventilatory support received as part of routine clinical care: an invasive mechanical ventilation cohort (CLEAR-MV) and a non-invasive ventilation cohort (CLEAR-NIV). Enrollment will occur at the time patients are considered clinically ready for ventilatory withdrawal assessment, either during a spontaneous breathing trial in the MV cohort or during a structured NIV withdrawal or low-support trial in the NIV cohort.
- Ages
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40 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Assuit Univeristy
RECRUITINGAsyut, Assuit Egypt, 71515, Egypt
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