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Completed
NCT06918288
Post-Extubation High-Flow Nasal Cannula Versus Non-Invasive Ventilation in Type II Respiratory Failure
Conditions: Type II Respiratory Failure, Hypercapnic Respiratory Failure
Sex: All
Ages: 51 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 200
Sponsor: Benha University
Location: Benha University Hospital Banhā Qalyubia Governorate
Summary
Acute hypercapnic respiratory failure is characterized by elevated arterial carbon dioxide levels and commonly occurs in patients with chronic respiratory diseases. Patients with type II respiratory failure who experience difficult weaning from invasive mechanical ventilation are at increased risk of post-extubation respiratory failure and reintubation. This randomized clinical trial compared high-flow nasal cannula (HFNC) with non-invasive ventilation (NIV) as respiratory support immediately after extubation in patients aged over 50 years with type II respiratory failure and difficult weaning. The primary objective was to compare reintubation rates at 72 hours and 7 days after extubation.
Eligibility Criteria
Inclusion Criteria:
* Age \>50 years.
* Type II respiratory failure.
* Receiving invasive mechanical ventilation.
* Difficult weaning from invasive mechanical ventilation, defined as failure to wean after 3-7 days of weaning attempts.
* Fulfillment of predefined clinical criteria for extubation.
* Written informed consent.
Exclusion Criteria:
* Refusal to participate or absence of informed consent.
* Contraindication to NIV, including hemodynamic instability, excessive respiratory secretions with poor expectoration ability, oral or facial trauma, or recent esophageal surgery.
* Poor short-term prognosis, including a very high risk of death within 7 days or receipt of palliative care.
* Severe failure of another organ system, including severe cardiac, neurological, renal, or hepatic failure.
* Existing tracheostomy.
* Loss to follow-up resulting in uncertain 28-day survival.
Source: ClinicalTrials.gov (NCT06918288). StuddyBuddy aggregates publicly available trial information.