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NCT Number: NCT06301035

Asymmetric High-flow Nasal Cannula (HFNC) vs Standard HFNC for Post Extubation High-risk Group

Background The exacerbation of respiratory failure that occurs after endotracheal intubation often occurs in patients who have received mechanical ventilation therapy, and when it occurs, it emerges as an important issue to consider reintubation of endotracheal intubation. High-flow nasal cannula (HFNC) through nasal cannula is known to produce positive airway pressure and deliver a certain amount of oxygen, and recently reported clinical studies have demonstrated the effect of lowering the risk of reintubation after endotracheal intubation, which is recommended for use in recent clinical practice guidelines. However, in patients at high risk of intubation failure, the combination of high-flow oxygen therapy and non-invasive positive-pressure ventilation therapy rather than the application of high-flow oxygen therapy alone through nasal cannula is helpful in reducing the rate of reintubation of endotracheal intubation. However, an alternative to non-invasive positive-pressure ventilation therapy is needed as there is a possibility of complications such as aspiration pneumonia, maladaptation of the application device (mask), and discomfort, making it difficult to apply it in the field.

Recently, it has been reported that high flow oxygen therapy through an asymmetric nasal cannula forms sufficient positive pressure in terms of respiratory dynamics, which makes the patient feel comfortable and reduces work of breath. However, no clinical studies have yet compared physiological effects using this method in patients at high risk of extubation failure.

Goal The investigators would like to compare the physiological effects of high flow oxygen therapy through 'asymmetric nasal cannula' with high flow oxygen therapy through 'standard nasal cannula' in patients identified as high-risk groups for valvular failure.

Hypothesis 'Asymmetric nasal cannula' reduces work of breath compared to 'standard nasal cannula' in high-risk patients with valvular failure.

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Key information

Conditions

Acute Respiratory Failure

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 19 years of age or older
  • Patients who applied mechanical ventilation treatment for more than 24 hours before the excision
  • Patients who underwent endotracheal intubation rather than tracheal incision
  • Planned extubation after successful spontaneous breathing trial (SBT)
  • Reintubation High Risk Patients: If any of the following conditions are met
  • Age > 65
  • Acute Physiology and Chronic Health Evaluation(APACHE) II on the day of extubation > 12
  • Body mass index (BMI) > 30 kg/m2
  • Inability to deal with respiratory secretions
  • improper cough reflex
  • If at least three aspirations are required in the 8 hours prior to the discharge
  • Difficult or long delay in mechanical ventilation
  • The first attempt to leave the mechanical ventilation failed
  • Charlson Commercial Index (CCI) at least 2 categories of comorbidities
  • Heart failure is the main indication of mechanical ventilation application
  • Moderate to severe chronic obstructive pulmonary disease
  • If there is a problem with airway openness (high risk of developing laryngeal edema)
  • a woman
  • Oral endotracheal intubation maintenance period of at least 3 days
  • Difficult to intubate endotracheally (difficult airway)
  • Long-term mechanical ventilation application: When applied for more than 7 days

Exclusion criteria

  • a patient with a tracheostomy tube
  • Contraindicated application of nasal interfaces
  • a nasal disorder
  • Continuous positive pressure (CPAP) application contraindications
  • pneumothorax, blistering lung disease, head trauma, cranial facial surgery, airway foreign matter, unstable hemodynamics, etc
  • EIT application contraindications
  • Patients using implantable electronic medical devices (such as implantable defibrillators, pacemakers or spinal cord stimulators)
  • a patient with hyperhidrosis
  • a patient whose physical movements are not controlled
  • a pregnant woman
  • BMI 50 or higher

Treatment and study plan

Asymmetric High flow nasal cannula

Device
  • Both the test group and the control group apply high flow oxygen therapy for at least 24 hours from the time of initial excretion (0h), and only the nasal interface is applied differently depending on the allocation group.
  • The initial flow rate setting is 10 L/min, and it can be adjusted up to 50 L/min within the range where the subject does not experience discomfort. Except for cases where the patient complains of being hot, the initial temperature setting is 37°C, and the inhaled oxygen concentration (FiO2) may be adjusted to a target of 93% or more of peripheral oxygen saturation (SpO2) in the range of 21 to 100%.
  • After 24 hours, high flow oxygen therapy is discontinued and conventional oxygen therapy can be applied if necessary.

Standard(symmetric) High flow nasal cannula

Device
  • Both the test group and the control group apply high flow oxygen therapy for at least 24 hours from the time of initial excretion (0h), and only the nasal interface is applied differently depending on the allocation group.
  • The initial flow rate setting is 10 L/min, and it can be adjusted up to 50 L/min within the range where the subject does not experience discomfort. Except for cases where the patient complains of being hot, the initial temperature setting is 37°C, and the inhaled oxygen concentration (FiO2) may be adjusted to a target of 93% or more of peripheral oxygen saturation (SpO2) in the range of 21 to 100%.
  • After 24 hours, high flow oxygen therapy is discontinued and conventional oxygen therapy can be applied if necessary.

Primary outcomes

  1. Respiratory Rate Oxygenation (ROX) Index

    Time frame: 1 hour, 2 hours, 6 hours, 12 hours, 24 hours

    Changes in Respiratory Rate Oxygenation (ROX) Index after extubation

    4.88 ≤ ROX index ; Low Risk 3.85 ≤ ROX index < 4.88 ; Re-evaluate after 1-2 hours 3.85 > ROX index ; considerate about intubation

Secondary outcomes

  1. The Lowest value of SpO2 within 24 hours after extubation

    Time frame: within 24 hours after extubation

    Gas exchange (blood gas analysis) - The Lowest value of SpO2 within 24 hours after extubation

  2. PaO2/FiO2

    Time frame: 30 minutes, 6 hours, 24 hours

    Gas exchange (blood gas analysis) - PaO2/FiO2

  3. SpO2/FiO2

    Time frame: 1 hour, 2 hours, 6 hours, 12 hours, 24 hours

    Gas exchange (blood gas analysis) - SpO2/FiO2

  4. changes of end-expiratory lung impedance, at each flow rate measured through Electrical Impedance tomography (EIT)

    Time frame: 1 hour, 2 hours, 6 hours, 12 hours, 24 hours

    Pulmonary Dynamics (EIT) - changes of end-expiratory lung impedance, at each flow rate measured through Electrical Impedance tomography (EIT)

  5. Changes in non-homogeneity indicators measured through EIT (changes in Global homeogeneity index)

    Time frame: 1 hour, 2 hours, 6 hours, 12 hours, 24 hours

    Pulmonary Dynamics (EIT) - Changes in non-homogeneity indicators measured through EIT (changes in Global homeogeneity index)

  6. Respiratory rate

    Time frame: 1 hour, 2 hours, 6 hours, 12 hours, 24 hours

    respiratory capacity indicator - Respiratory rate

  7. work of breath (Modified Borg Scale, MBS)

    Time frame: 1 hour, 2 hours, 6 hours, 12 hours, 24 hours

    respiratory capacity indicator - work of breath (Modified Borg Scale, MBS)

    :The degree of work of breath is indicated by the patient himself/herself 0: Nothing at all 0.5: Very, very slight (just noticeable)

    • Very slight
    • Slight
    • Moderate
    • Somewhat severe 5,: Severe 6, 7: Very severe 8, 9: Very, very severe (almost maximal)

    10: Maximal

  8. systolic blood pressure

    Time frame: 1 hour, 2 hours, 6 hours, 12 hours, 24 hours

    hemodynamics - systolic blood pressure

  9. mean arterial pressure

    Time frame: 1 hour, 2 hours, 6 hours, 12 hours, 24 hours

    hemodynamics - mean arterial pressure

  10. heart rate

    Time frame: 1 hour, 2 hours, 6 hours, 12 hours, 24 hours

    hemodynamics - heart rate

  11. Rate of reintubation within 7 days

    Time frame: within 7 days after extubation

    clinical outcomes - Rate of reintubation within 7 days

  12. Length of ICU stay

    Time frame: From date of ICU admission until the date of ICU discharge, assessed up to 2 years

    clinical outcomes - Length of ICU stay

  13. Length of hospital stay

    Time frame: From date of hospital admission until the date of hospital discharge, assessed up to 2 years

    clinical outcomes - Length of hospital stay

  14. ICU Mortality

    Time frame: From date of extubation until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 1 year

    clinical outcomes - ICU Mortality

  15. Hospital Mortality

    Time frame: From date of extubation until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 1 year

    clinical outcomes - Hospital Mortality

  16. 28 Day Mortality

    Time frame: From date of extubation until the date of 28 Day or date of death from any cause, whichever came first, assessed up to 1 months

    clinical outcomes - 28 Day Mortality

  17. 90 Day Mortality

    Time frame: From date of extubation until the date of 90 Day or date of death from any cause, whichever came first, assessed up to 3 months

    clinical outcomes - 90 Day Mortality

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Fisher and Paykel Healthcare

Registry information

Official study title

Comparison of Asymmetric High-flow Nasal Cannula (HFNC) and Standard HFNC in Post Extubation High-risk Group: A Prospective, Single-center, Open-labeled, Randomized Controlled Pilot Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 8, 2024
Registry last updated
Aug 11, 2025

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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