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NCT Number: NCT06918288

Post-Extubation High-Flow Nasal Cannula Versus Non-Invasive Ventilation in Type II Respiratory Failure

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.

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Key information

Conditions

Type II Respiratory Failure Hypercapnia Hypercapnic Respiratory Failure Hypoventilation Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

51 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 >50 years.
  • Type II respiratory failure.
  • Receiving invasive mechanical ventilation.
  • Difficult weaning from invasive mechanical ventilation, defined as failure to wean after 3-7 days of weaning attempts.
  • Fulfillment of predefined clinical criteria for extubation.
  • Written informed consent.

Exclusion criteria

  • Refusal to participate or absence of informed consent.
  • Contraindication to NIV, including hemodynamic instability, excessive respiratory secretions with poor expectoration ability, oral or facial trauma, or recent esophageal surgery.
  • Poor short-term prognosis, including a very high risk of death within 7 days or receipt of palliative care.
  • Severe failure of another organ system, including severe cardiac, neurological, renal, or hepatic failure.
  • Existing tracheostomy.
  • Loss to follow-up resulting in uncertain 28-day survival.

Treatment and study plan

High-Flow Nasal Cannula (HFNC)

Device

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.

Non-invasive ventilation (NIV)

Device

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.

Primary outcomes

  1. Reintubation Rate

    Time frame: At 72 hours and 7 days after extubation

    Number and proportion of participants requiring reinstitution of invasive mechanical ventilation after planned extubation.

Secondary outcomes

  1. Treatment Failure Rate

    Time frame: Within 48 hours after extubation

    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.

  2. Ventilator-Free Days at Day 28

    Time frame: During the first 28 days after extubation

    Number of days alive and free from invasive mechanical ventilation during the first 28 days after randomization.

  3. Duration of Post-Extubation Respiratory Support

    Time frame: Through 72 hours after extubation

    Duration of respiratory support with HFNC or NIV following extubation.

  4. Arterial Blood pH

    Time frame: At 1, 12, 24, and 48 hours after extubation

    Arterial blood pH measured by arterial blood gas analysis after extubation.

  5. Arterial Partial Pressure of Carbon Dioxide (PaCO2)

    Time frame: At 1, 12, 24, and 48 hours after extubation

    PaCO2 measured by arterial blood gas analysis after extubation.

  6. Arterial Bicarbonate (HCO3)

    Time frame: At 1, 12, 24, and 48 hours after extubation

    Arterial bicarbonate concentration measured as part of arterial blood gas analysis after extubation.

  7. PaO2/FiO2 Ratio

    Time frame: At 1, 12, 24, and 48 hours after extubation

    Ratio of arterial partial pressure of oxygen (PaO2) to fraction of inspired oxygen (FiO2), used to assess oxygenation after extubation.

  8. Post-Extubation Complications

    Time frame: From extubation through 28 days after randomization

    Incidence of post-extubation complications were recorded during follow-up in the HFNC and NIV groups.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Post-Extubation Support Using Nasal Humidified High-Flow Oxygen Versus Non-Invasive Positive Pressure Mechanical Ventilation in Preventing Reintubation Among Patients With Type II Respiratory Failure

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 9, 2025
Registry last updated
Aug 25, 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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