An interventional study of High-Flow Nasal Cannula (HFNC) and Non-Invasive Ventilation (NIV) in Type II Respiratory Failure and Hypercapnic Respiratory Failure, sponsored by Benha University. Completed at 1 site in Egypt. Open to participants aged 51 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Benha University · Not applicable, Interventional, and Prevention
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.
96 studies on the registry are indexed under Hypoventilation; 21 are open to participants now.
This study's enrollment of 200 is above the median of 52 across 63 interventional studies indexed under Hypoventilation.
Browse Hypoventilation studies →Benha University is the lead sponsor of 362 studies on the registry; 66 are open to participants now.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
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Participants randomized to this group received high-flow nasal cannula immediately after extubation. The initial airflow was set at 50 L/min and subsequently adjusted according to patient tolerance. Absolute humidity was set at 44 mg H2O/L and temperature at 37°C. Therapy was adjusted to maintain SpO2 between 88% and 92% and respiratory rate below 30 breaths/min or at the pre-extubation baseline. Escalation to NIV or invasive mechanical ventilation because of respiratory failure was considered HFNC treatment failure.
Device: High-Flow Nasal Cannula (HFNC)
Participants randomized to this group received non-invasive ventilation immediately after extubation through a conventional oronasal mask using spontaneous/timed (S/T) mode. Expiratory positive airway pressure was initially set at 4 cmH2O and inspiratory pressure at 8 cmH2O, with subsequent adjustment according to patient tolerance and to achieve a tidal volume of 6-8 mL/kg. Pressure support and FiO2 were adjusted to maintain SpO2 between 88% and 92%, respiratory rate ≤30 breaths/min or at the pre-extubation baseline, and PaCO2 between 45 and 60 mmHg or at the most recent pre-extubation value. Requirement for invasive mechanical ventilation was considered NIV treatment failure.
Device: Non-Invasive Ventilation (NIV)
Heated and humidified high-flow oxygen was delivered through a nasal cannula immediately after extubation. The device provided adjustable high-flow oxygen to achieve the predefined oxygenation and respiratory-rate targets.
Positive-pressure ventilatory support was delivered immediately after extubation through a conventional oronasal mask using spontaneous/timed (S/T) ventilation, with pressure and inspired oxygen adjusted according to predefined respiratory and gas-exchange targets.
Reintubation Rate
Number and proportion of participants requiring reinstitution of invasive mechanical ventilation after planned extubation.
Time frame: At 72 hours and 7 days after extubation
Treatment Failure Rate
Treatment failure was defined as escalation from HFNC to NIV or invasive mechanical ventilation in the HFNC group and requirement for invasive mechanical ventilation in the NIV group.
Time frame: Within 48 hours after extubation
Ventilator-Free Days at Day 28
Number of days alive and free from invasive mechanical ventilation during the first 28 days after randomization.
Time frame: During the first 28 days after extubation
Duration of Post-Extubation Respiratory Support
Duration of respiratory support with HFNC or NIV following extubation.
Time frame: Through 72 hours after extubation
Arterial Blood pH
Arterial blood pH measured by arterial blood gas analysis after extubation.
Time frame: At 1, 12, 24, and 48 hours after extubation
Arterial Partial Pressure of Carbon Dioxide (PaCO2)
PaCO2 measured by arterial blood gas analysis after extubation.
Time frame: At 1, 12, 24, and 48 hours after extubation
Arterial Bicarbonate (HCO3)
Arterial bicarbonate concentration measured as part of arterial blood gas analysis after extubation.
Time frame: At 1, 12, 24, and 48 hours after extubation
PaO2/FiO2 Ratio
Ratio of arterial partial pressure of oxygen (PaO2) to fraction of inspired oxygen (FiO2), used to assess oxygenation after extubation.
Time frame: At 1, 12, 24, and 48 hours after extubation
Post-Extubation Complications
Incidence of post-extubation complications were recorded during follow-up in the HFNC and NIV groups.
Time frame: From extubation through 28 days after randomization
Plan to share: No
Ran from Apr 2025 to primary completion in Nov 2025, 7 months.
Of 35 non-industry interventional studies with no phase under Hypoventilation, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's 7 months is below that.
Counting every sponsor, half of 35 studies reached it within 15 months; a quarter within 5 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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