New study tests gentler oxygen therapy for COPD patients after ventilator
NCT ID NCT07381686
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at 150 adults with COPD who have just had a breathing tube removed. It compares two ways to help them breathe: a high-flow nasal cannula (a soft tube that delivers warm, moist oxygen) versus noninvasive ventilation (a mask that pushes air into the lungs). The goal is to see which method better prevents the need for another breathing tube within 72 hours.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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150 people
The number who actually took part.
- Started
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Jan 2026
- Expected to finish
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Nov 2026
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.
- Ages
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18 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.
1. Age ≥ 18 years. 2. Established COPD diagnosis (clinical history + prior spirometry confirming persistent airflow limitation, if available). 3. Recently extubated after invasive mechanical ventilation for an acute COPD exacerbation. 4. Mild hypercapnic respiratory failure post-extubation, defined as: PaCO₂ 45-60 mmHg (or ≥10 mmHg above known baseline) and pH ≥ 7.30, and Respiratory rate ≥ 20/min or increased work of breathing. 5. Hemodynamic stability: MAP ≥ 65 mmHg without escalating vasopressors. 6. Adequate airway protection: GCS ≥ 13, no active vomiting, manageable secretions. 7. Oxygenation compatible with noninvasive support (e.g., SpO₂ ≥ 88-92% achievable with FiO₂ ≤ 0.6 during screening). 8. Ability to give informed consent (patient or legal surrogate). Exclusion criteria: 1. Severe acidosis or severe hypercapnia: pH \< 7.30 or PaCO₂ \> 60 mmHg requiring immediate escalation. 2. Impending respiratory arrest or immediate need for re-intubation (severe hypoxemia, refractory distress, profound altered mental status). 3. Severe hypoxemia not compatible with trial modalities (e.g., need for FiO₂ \> 0.8 or PEEP \> 10 cmH₂O to keep SpO₂ ≥ 88%). 4. Hemodynamic instability: shock with rapidly escalating vasopressors, malignant arrhythmia, or active myocardial ischemia. 5. Severe encephalopathy (GCS \< 13) or inability to protect airway. 6. Massive hemoptysis, active upper GIT bleeding, or untreated pneumothorax. 7. Post-extubation laryngeal edema/stridor requiring immediate re-intubation. 8. Absolute/relative contraindications to NIV (mask-based): facial trauma/burns, recent facial/upper airway or gastric surgery, fixed upper airway obstruction, uncontrolled vomiting, severe agitation or mask intolerance. 9. Contraindications to HFNC judged by the treating team (rare; e.g., complete nasal obstruction).
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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.
Contacts and locations
Locations
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Assiut University
Asyut, أسيوط - Asyut Governorate, 71511, Egypt
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