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Completed

NCT Number: NCT07630766

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

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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Key information

Conditions

Extubation Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benha University Hospital

Banhā, Qalyubia Governorate, 13511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years.
  • Received invasive mechanical ventilation for at least 24 hours.
  • Considered ready for planned extubation after successful completion of a spontaneous breathing trial.
  • 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

  • Age <18 years.
  • Presence of a tracheostomy.
  • Accidental extubation.
  • Self-extubation.
  • Contraindication to noninvasive ventilation.

Treatment and study plan

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.

Primary outcomes

  1. Reintubation Rate

    Time frame: 7 days

    Proportion of patients requiring reintubation following planned extubation.

Secondary outcomes

  1. Time to Reintubation

    Time frame: 7 days

    Time elapsed from extubation to reintubation among patients requiring reintubation.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Acronym: NIV-HFNC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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