Acute Respiratory FailureNCT06301035
Asymmetric High-flow Nasal Cannula (HFNC) vs Standard HFNC for Post Extubation High-risk Group
A study testing Asymmetric High flow nasal cannula and Standard(symmetric) High flow nasal cannula in people with Acute Respiratory Failure, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- Asymmetric High flow nasal cannula and Standard(symmetric) High flow nasal cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jun 2024to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 21Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read more
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.
- Conditions
- Acute Respiratory Failure
- Being tested
- Asymmetric High flow nasal cannula, Standard(symmetric) High flow nasal cannula
- Keywords
- High flow nasal cannula, Electrial impedance tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asymmetric High flow nasal cannulaDevice
- 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 cannulaDevice
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Asymmetric HFNC | Experimental | Asymmetric HFNC Receives: Device: Asymmetric High flow nasal cannula |
| Standard HFNC | Active comparator | Standard HFNC Receives: Device: Standard(symmetric) High flow nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Rate Oxygenation (ROX) Index
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
Measured: 1 hour, 2 hours, 6 hours, 12 hours, 24 hours
Secondary outcomes (17)
The Lowest value of SpO2 within 24 hours after extubation
Gas exchange (blood gas analysis) - The Lowest value of SpO2 within 24 hours after extubation
Measured: within 24 hours after extubation
PaO2/FiO2
Gas exchange (blood gas analysis) - PaO2/FiO2
Measured: 30 minutes, 6 hours, 24 hours
SpO2/FiO2
Gas exchange (blood gas analysis) - SpO2/FiO2
Measured: 1 hour, 2 hours, 6 hours, 12 hours, 24 hours
changes of end-expiratory lung impedance, at each flow rate measured through Electrical Impedance tomography (EIT)
Pulmonary Dynamics (EIT) - changes of end-expiratory lung impedance, at each flow rate measured through Electrical Impedance tomography (EIT)
Measured: 1 hour, 2 hours, 6 hours, 12 hours, 24 hours
Changes in non-homogeneity indicators measured through EIT (changes in Global homeogeneity index)
Pulmonary Dynamics (EIT) - Changes in non-homogeneity indicators measured through EIT (changes in Global homeogeneity index)
Measured: 1 hour, 2 hours, 6 hours, 12 hours, 24 hours
Respiratory rate
respiratory capacity indicator - Respiratory rate
Measured: 1 hour, 2 hours, 6 hours, 12 hours, 24 hours
work of breath (Modified Borg Scale, MBS)
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
Measured: 1 hour, 2 hours, 6 hours, 12 hours, 24 hours
systolic blood pressure
hemodynamics - systolic blood pressure
Measured: 1 hour, 2 hours, 6 hours, 12 hours, 24 hours
mean arterial pressure
hemodynamics - mean arterial pressure
Measured: 1 hour, 2 hours, 6 hours, 12 hours, 24 hours
heart rate
hemodynamics - heart rate
Measured: 1 hour, 2 hours, 6 hours, 12 hours, 24 hours
Rate of reintubation within 7 days
clinical outcomes - Rate of reintubation within 7 days
Measured: within 7 days after extubation
Length of ICU stay
clinical outcomes - Length of ICU stay
Measured: From date of ICU admission until the date of ICU discharge, assessed up to 2 years
Length of hospital stay
clinical outcomes - Length of hospital stay
Measured: From date of hospital admission until the date of hospital discharge, assessed up to 2 years
ICU Mortality
clinical outcomes - ICU Mortality
Measured: 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
Hospital Mortality
clinical outcomes - Hospital Mortality
Measured: 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
28 Day Mortality
clinical outcomes - 28 Day Mortality
Measured: 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
90 Day Mortality
clinical outcomes - 90 Day Mortality
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start20 Jun 2024
- Primary completion16 Apr 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Responsible party
- Principal investigator, Chi Ryang Chung, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06301035
- Sponsor's protocol ID
- 2024-01-012
- Status last verified
- Aug 2025
- First submitted
- 22 Jan 2024
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hernandez G, Vaquero C, Colinas L, Cuena R, Gonzalez P, Canabal A, Sanchez S, Rodriguez ML, Villasclaras A, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in High-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Oct 18;316(15):1565-1574. doi: 10.1001/jama.2016.14194.
PubMed 27706464Thille AW, Muller G, Gacouin A, Coudroy R, Decavele M, Sonneville R, Beloncle F, Girault C, Dangers L, Lautrette A, Cabasson S, Rouze A, Vivier E, Le Meur A, Ricard JD, Razazi K, Barberet G, Lebert C, Ehrmann S, Sabatier C, Bourenne J, Pradel G, Bailly P, Terzi N, Dellamonica J, Lacave G, Danin PE, Nanadoumgar H, Gibelin A, Zanre L, Deye N, Demoule A, Maamar A, Nay MA, Robert R, Ragot S, Frat JP; HIGH-WEAN Study Group and the REVA Research Network. Effect of Postextubation High-Flow Nasal Oxygen With Noninvasive Ventilation vs High-Flow Nasal Oxygen Alone on Reintubation Among Patients at High Risk of Extubation Failure: A Randomized Clinical Trial. JAMA. 2019 Oct 15;322(15):1465-1475. doi: 10.1001/jama.2019.14901.
PubMed 31577036Slobod D, Spinelli E, Crotti S, Lissoni A, Galazzi A, Grasselli G, Mauri T. Effects of an asymmetrical high flow nasal cannula interface in hypoxemic patients. Crit Care. 2023 Apr 18;27(1):145. doi: 10.1186/s13054-023-04441-6.
PubMed 37072854Tan D, Walline JH, Ling B, Xu Y, Sun J, Wang B, Shan X, Wang Y, Cao P, Zhu Q, Geng P, Xu J. High-flow nasal cannula oxygen therapy versus non-invasive ventilation for chronic obstructive pulmonary disease patients after extubation: a multicenter, randomized controlled trial. Crit Care. 2020 Aug 6;24(1):489. doi: 10.1186/s13054-020-03214-9.
PubMed 32762701Hernandez G, Paredes I, Moran F, Buj M, Colinas L, Rodriguez ML, Velasco A, Rodriguez P, Perez-Pedrero MJ, Suarez-Sipmann F, Canabal A, Cuena R, Blanch L, Roca O. Effect of postextubation noninvasive ventilation with active humidification vs high-flow nasal cannula on reintubation in patients at very high risk for extubation failure: a randomized trial. Intensive Care Med. 2022 Dec;48(12):1751-1759. doi: 10.1007/s00134-022-06919-3. Epub 2022 Nov 18.
PubMed 36400984Tatkov S, Rees M, Gulley A, van den Heuij LGT, Nilius G. Asymmetrical nasal high flow ventilation improves clearance of CO2 from the anatomical dead space and increases positive airway pressure. J Appl Physiol (1985). 2023 Feb 1;134(2):365-377. doi: 10.1152/japplphysiol.00692.2022. Epub 2023 Jan 12.
PubMed 36633864
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06301035
- Acronym / sponsor ID
- 2024-01-012
- Conditions
- Acute Respiratory Failure
- Keywords
- High flow nasal cannula, Electrial impedance tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 16 Apr 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asymmetric HFNC | Experimental | Device: Asymmetric High flow nasal cannulaAsymmetric HFNC |
| Standard HFNC | Active comparator | Device: Standard(symmetric) High flow nasal cannulaStandard HFNC |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (11 listed)
- a patient with a tracheostomy tube
- Contraindicated application of nasal interfaces
- Continuous positive pressure (CPAP) application contraindications
- EIT application contraindications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Asymmetric High flow nasal cannula* 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. | Device | Asymmetric HFNC |
| Standard(symmetric) High flow nasal cannula* 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. | Device | Standard HFNC |
Primary outcome
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
17 secondary outcomes
The Lowest value of SpO2 within 24 hours after extubation
Time frame: within 24 hours after extubation
PaO2/FiO2
Time frame: 30 minutes, 6 hours, 24 hours
SpO2/FiO2
Time frame: 1 hour, 2 hours, 6 hours, 12 hours, 24 hours
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
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
Respiratory rate
Time frame: 1 hour, 2 hours, 6 hours, 12 hours, 24 hours
work of breath (Modified Borg Scale, MBS)
Time frame: 1 hour, 2 hours, 6 hours, 12 hours, 24 hours
systolic blood pressure
Time frame: 1 hour, 2 hours, 6 hours, 12 hours, 24 hours
mean arterial pressure
Time frame: 1 hour, 2 hours, 6 hours, 12 hours, 24 hours
heart rate
Time frame: 1 hour, 2 hours, 6 hours, 12 hours, 24 hours
Rate of reintubation within 7 days
Time frame: within 7 days after extubation
Length of ICU stay
Time frame: From date of ICU admission until the date of ICU discharge, assessed up to 2 years
Length of hospital stay
Time frame: From date of hospital admission until the date of hospital discharge, assessed up to 2 years
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Background: PubMed 27706464Hernandez G, Vaquero C, Colinas L, Cuena R, Gonzalez P, Canabal A, Sanchez S, Rodriguez ML, Villasclaras A, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in High-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Oct 18;316(15):1565-1574. doi: 10.1001/jama.2016.14194.
- Background: PubMed 31577036Thille AW, Muller G, Gacouin A, Coudroy R, Decavele M, Sonneville R, Beloncle F, Girault C, Dangers L, Lautrette A, Cabasson S, Rouze A, Vivier E, Le Meur A, Ricard JD, Razazi K, Barberet G, Lebert C, Ehrmann S, Sabatier C, Bourenne J, Pradel G, Bailly P, Terzi N, Dellamonica J, Lacave G, Danin PE, Nanadoumgar H, Gibelin A, Zanre L, Deye N, Demoule A, Maamar A, Nay MA, Robert R, Ragot S, Frat JP; HIGH-WEAN Study Group and the REVA Research Network. Effect of Postextubation High-Flow Nasal Oxygen With Noninvasive Ventilation vs High-Flow Nasal Oxygen Alone on Reintubation Among Patients at High Risk of Extubation Failure: A Randomized Clinical Trial. JAMA. 2019 Oct 15;322(15):1465-1475. doi: 10.1001/jama.2019.14901.
- Background: PubMed 37072854Slobod D, Spinelli E, Crotti S, Lissoni A, Galazzi A, Grasselli G, Mauri T. Effects of an asymmetrical high flow nasal cannula interface in hypoxemic patients. Crit Care. 2023 Apr 18;27(1):145. doi: 10.1186/s13054-023-04441-6.
- Background: PubMed 32762701Tan D, Walline JH, Ling B, Xu Y, Sun J, Wang B, Shan X, Wang Y, Cao P, Zhu Q, Geng P, Xu J. High-flow nasal cannula oxygen therapy versus non-invasive ventilation for chronic obstructive pulmonary disease patients after extubation: a multicenter, randomized controlled trial. Crit Care. 2020 Aug 6;24(1):489. doi: 10.1186/s13054-020-03214-9.
- Background: PubMed 36400984Hernandez G, Paredes I, Moran F, Buj M, Colinas L, Rodriguez ML, Velasco A, Rodriguez P, Perez-Pedrero MJ, Suarez-Sipmann F, Canabal A, Cuena R, Blanch L, Roca O. Effect of postextubation noninvasive ventilation with active humidification vs high-flow nasal cannula on reintubation in patients at very high risk for extubation failure: a randomized trial. Intensive Care Med. 2022 Dec;48(12):1751-1759. doi: 10.1007/s00134-022-06919-3. Epub 2022 Nov 18.
- Background: PubMed 36633864Tatkov S, Rees M, Gulley A, van den Heuij LGT, Nilius G. Asymmetrical nasal high flow ventilation improves clearance of CO2 from the anatomical dead space and increases positive airway pressure. J Appl Physiol (1985). 2023 Feb 1;134(2):365-377. doi: 10.1152/japplphysiol.00692.2022. Epub 2023 Jan 12.
- Individual participant dataSharing planned: No
Related trials for Acute Respiratory Failure
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Regional Lung Ventilation During Prone Position in in Intubated Children
Pediatric Acute Respiratory Failure
Not yet recruiting
Influence of Patient Positioning During Nasal Lavage
Acute Upper Respiratory Tract Infections, Nasal Obstruction
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Asymmetric High flow nasal cannula and Standard(symmetric) High flow nasal cannula in people with Acute Respiratory Failure, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Rate Oxygenation (ROX) Index (time frame: 1 hour, 2 hours, 6 hours, 12 hours, 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06301035, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.