Noninvasive Ventilation Versus High-Flow Nasal Cannula After Extubation in High-Risk ICU Patients

NCT07630766 — Not applicable, Completed, 102 participants, Benha University

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Comparative Study Between Noninvasive Ventilation and High Flow Nasal Cannula in Patients With High Risk of Extubation Failure

Registry	NCT07630766, acronym NIV-HFNC
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	102 (Actual)
Sponsor	Benha University (Other)
Conditions	Extubation Failure
Interventions	NIV, HFNC (Device)
Dates	start 2025-07-30, primary completion 2026-04-30, completion 2026-05-15, first posted 2026-06-05, last updated 2026-06-11
Locations	1 site in Egypt

-Summary

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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+Arms and interventions

Arm	Type	Interventions	Description
NIV	Experimental	Device: NIV	Patients received noninvasive ventilation immediately after planned extubation according to the study protocol.
HFNC	Active comparator	Device: HFNC	Patients received high-flow nasal cannula oxygen therapy immediately after planned extubation according to the study protocol.

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.
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.

+Outcome measures

Primary outcomes

Reintubation Rate [7 days]: Proportion of patients requiring reintubation following planned extubation.

Secondary outcomes

Time to Reintubation [7 days]: Time elapsed from extubation to reintubation among patients requiring reintubation.

+Eligibility

Sex: All, ages: 18 Years to any

inclusion criteria

1. Age ≥18 years.
2. Received invasive mechanical ventilation for at least 24 hours.
3. Considered ready for planned extubation after successful completion of a spontaneous breathing trial.
4. High risk of extubation failure, defined by the presence of at least four of the following risk factors:

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:

1. Age <18 years.
2. Presence of a tracheostomy.
3. Accidental extubation.
4. Self-extubation.
5. Contraindication to noninvasive ventilation.

+Locations (1)

Facility	City	Country	Status
Benha University Hospital	Banhā, Qalyubia Governorate	Egypt