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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NIV | Experimental | Patients received noninvasive ventilation immediately after planned extubation according to the study protocol. |
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| HFNC | Active Comparator | Patients received high-flow nasal cannula oxygen therapy immediately after planned extubation according to the study protocol. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIV | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reintubation Rate | Proportion of patients requiring reintubation following planned extubation. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reintubation | Time elapsed from extubation to reintubation among patients requiring reintubation. | 7 days |
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inclusion criteria
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benha University Hospital | Banhā | Qalyubia Governorate | 13511 | Egypt |
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Participants were randomly assigned in a parallel-group design to receive either noninvasive ventilation (NIV) or high-flow nasal cannula (HFNC) immediately after planned extubation. Outcomes were compared between the two groups during follow-up.
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Due to the nature of the interventions, blinding of participants and treating clinicians was not feasible. However, outcome assessors and data analysts were blinded to treatment allocation to minimize assessment bias.
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| HFNC | Device | 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. |
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