An interventional study of NIV and HFNC in Extubation Failure, sponsored by Benha University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by Benha University · Not applicable, Interventional, and Treatment
Extubation failure is associated with increased morbidity and mortality in critically ill patients. High-risk patients may benefit from preventive respiratory support after extubation. This randomized controlled trial compared noninvasive ventilation (NIV) with high-flow nasal cannula (HFNC) in adult intensive care unit (ICU) patients at high risk of extubation failure. The study evaluated reintubation rates, time to reintubation, physiological parameters, complications, and clinical outcomes following planned extubation. The aim was to determine the optimal post-extubation respiratory support strategy for reducing extubation failure in high-risk ICU patients.
Benha University is the lead sponsor of 356 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Age >65 years. APACHE II score >12 on the day of extubation. Body mass index >30 kg/m². Inadequate secretion management. Difficult or prolonged weaning. Two or more comorbidities. Acute heart failure requiring mechanical ventilation. Moderate-to-severe chronic obstructive pulmonary disease. Airway patency problems. Prolonged mechanical ventilation. Hypercapnia at the end of the spontaneous breathing trial.
Exclusion Criteria:
Patients received noninvasive ventilation immediately after planned extubation according to the study protocol.
Device: NIV
Patients received high-flow nasal cannula oxygen therapy immediately after planned extubation according to the study protocol.
Device: HFNC
NIV was initiated immediately after extubation using bilevel positive airway pressure delivered via a properly fitted face mask with active humidification using a Dräger Savina 300 ventilator (Drägerwerk AG \& Co. KGaA, Lübeck, Germany). Ventilator settings were adjusted to achieve a respiratory rate \<26 breaths/min, tidal volume of 6-8 mL/kg predicted body weight, and adequate oxygenation (SpO₂ ≥92%, pH ≥7.35). Sedation was not permitted.
HFNC was applied immediately after extubation using a heated humidified high-flow nasal cannula system (BioVent A-Series, Model: BioHF BB60101; BIO-AOI, Cairo, Egypt). Flow was initially set at 10 L/min and titrated up to 60 L/min according to patient tolerance. Gas temperature was maintained at 37°C. In both groups, FiO₂ was adjusted to maintain SpO₂ ≥92%. After 48 hours, respiratory support was discontinued and conventional oxygen therapy was provided if required. Rescue NIV was not allowed in the HFNC group. All patients received standardized care.
Reintubation Rate
Proportion of patients requiring reintubation following planned extubation.
Time frame: 7 days
Time to Reintubation
Time elapsed from extubation to reintubation among patients requiring reintubation.
Time frame: 7 days
Plan to share: No
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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Benha University