Extubation ReadinessNCT07007715
Identifying the Best Flow Setting Strategy for High-Flow Nasal Cannula
A study testing Flow of 40L/min, Peak tidal inspiratory flow (PTIF) guided and PaO2/FiO2 ratio guided in people with Extubation Readiness and Respiratory Failure With Hypoxia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The goal of this randomized trial is to compare four different flow-setting approaches for post-extubation use of high-flow nasal cannula (HFNC). Selecting the appropriate flow rate when initiating HFNC oxygen therapy is both crucial and challenging for clinicians, as the physiological benefits of HFNC depend… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extubation Readiness, Respiratory Failure With Hypoxia
- What is being tested?
- Flow of 40L/min, Peak tidal inspiratory flow (PTIF) guided and PaO2/FiO2 ratio guided
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Jun 2025to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Intubated and receiving mechanical ventilation for more than 24 hours
- Ready for planned extubation after passing a spontaneous breathing trial
- PaO2/FiO2 <350 mmHg on the day of extubation
Who cannot join
- Age <18 years
- On do-not-reintubate code
- Pregnant women
- Having tracheostomies
- Infeasibility of using HFNC
- Planning to use preventive NIV after extubation by the primary care team
- Life expectancy less than one month
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Research Ethics Committee of NTUH, 886223951950, ntuhrec@ntuh.gov.tw
About this study
Official title: Optimizing High-flow Nasal Cannula Settings: Comparing Different Flow Approaches and Exploring Physiological Phenotyping With End-expiratory Lung Volume, Peak Tidal Inspiratory Flow and Oxygen Demand
The goal of this randomized trial is to compare four different flow-setting approaches for post-extubation use of high-flow nasal cannula (HFNC). Selecting the appropriate flow rate when initiating HFNC oxygen therapy is both crucial and challenging for clinicians, as the physiological benefits of HFNC depend significantly on the flow rate. To date, there are no guidelines or consensus on flow-rate setting and weaning for HFNC oxygen therapy.
The investigators hypothesized that physiological marker-guided flow setting using peak tidal inspiratory flow (PTIF) or PaO₂/FiO₂ ratios lead to better extubation outcomes as compared to empirical flow setting of 40 L/min or 60 L/min.
Participants will be randomly assigned to one of four study groups with different flow setting strategies summarized as follows: (1) Setting flow at 40 L/min, (2) Setting flow at 5 L/min above the peak tidal inspiratory flow, up to a maximum of 60 L/min. (3) Setting flow according to P/F ratio prior to extubation. Flow will be set at 60, 50 40 L/min if P/F ratio <250 mmHg, 250-300 mmHg and >300 mmHg, respectively. (4) Setting flow at 60 L/min.
Read the detailed description
High-flow nasal cannula (HFNC) is a promising intervention for post-extubation oxygen therapy, with the potential to improve oxygenation, increase end-expiratory lung volume (EELV), reduce the work of breathing, and lower the risk of reintubation. Selecting an appropriate flow rate when initiating HFNC therapy is both crucial and challenging for clinicians. Although the physiological benefits of HFNC depend significantly on the flow rate, arbitrarily applying higher flow rates without appropriate patient selection may increase the risk of barotrauma and patient discomfort. Currently, there are no established guidelines or consensus on flow-rate setting for HFNC therapy. Given the growing use of HFNC, determining the optimal flow-setting strategy is urgently needed to ensure both clinical efficacy and cost-effectiveness.
This 4-arm parallel-group randomized trial aims to compare four different flow-setting approaches for post-extubation use of HFNC in extubation outcomes. The individual flow-setting strategy for each study arm is summarized as follows: (1) Setting flow at 40 L/min, (2) Setting flow at 5 L/min above the peak tidal inspiratory flow, up to a maximum of 60 L/min. (3) Setting flow according to P/F ratio prior to extubation. Flow will be set at 60, 50 40 L/min if P/F ratio <250 mmHg, 250-300 mmHg and >300 mmHg, respectively. (4) Setting flow at 60 L/min. In addition, this study will incorporate measurements of peak tidal inspiratory flow and EELV to highlight the physiological characteristics of individual patients. These physiological measures may serve as both explanatory variables and potential predictors of flow responders. By examining the associations among flow responders, peak tidal inspiratory flow, pre-extubation oxygen demand, and changes in EELV, we aim to develop a comprehensive understanding of the mechanisms and key factors influencing flow responsiveness during post-extubation care with HFNC.
- Being tested
- Flow of 40L/min, Peak tidal inspiratory flow (PTIF) guided, PaO2/FiO2 ratio guided, Flow of 60L/min
- Keywords
- flow rate, high flow nasal cannula, peak inspiratory flow, reintubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow of 40L/minOther
Setting flow rate at 40L/min
Peak tidal inspiratory flow (PTIF) guidedOther
Setting HFNC flow at 5 L/min above the peak tidal inspiratory flow (PTIF), up to a maximum of 60 L/min.
PaO2/FiO2 ratio guidedOther
Setting HFNC flow according to P/F ratio prior to extubation. Flow will be set at 60, 50 40 L/min if P/F ratio <250 mmHg, 250-300 mmHg and >300 mmHg, respectively.
Flow of 60L/minOther
Setting flow rate at 60L/min
| Study group | Role | What they receive |
|---|---|---|
| Flow of 40L/min | Active comparator | Setting HFNC flow at 40 L/min Receives: Other: Flow of 40L/min |
| Peak tidal inspiratory flow (PTIF) guided | Experimental | Setting HFNC flow at 5 L/min above the peak tidal inspiratory flow (PTIF), up to a maximum of 60 L/min. Receives: Other: Peak tidal inspiratory flow (PTIF) guided |
| PaO2/FiO2 ratio guided | Experimental | Setting HFNC flow according to P/F ratio prior to extubation. Flow will be set at 60, 50 40 L/min if P/F ratio <250 mmHg, 250-300 mmHg and >300 mmHg, respectively. Receives: Other: PaO2/FiO2 ratio guided |
| Flow of 60L/min | Experimental | Setting HFNC flow at 60 L/min Receives: Other: Flow of 60L/min |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite outcome of noninvasive ventilation (NIV) use or reintubation within five days after extubation
A single global test of significance to compare between-group difference in the composite outcome
Measured: 5 days
Secondary outcomes (6)
Proportion of reintubation within five days after extubation
A single global test of significance to compare between-group difference in proportion of reintubation within five days
Measured: 5 days
Proportion of NIV use within five days after extubation
A single global test of significance to compare between-group difference in proportion of NIV use within five days.
Measured: 5 days
28-day mortality
28-day mortality
Measured: 28 days
Change in PaO2/FiO2 ratio between 0 and 24th hour
Change in PaO2/FiO2 ratio between 0 and 24th hour
Measured: 24 hours
Change in arterial CO2 level (mmHg) between 0 and 24th hour
Change in arterial CO2 level (mmHg) between 0 and 24th hour
Measured: 24 hours
Proportion of ahead-of-schedule change in flow rates in 24 hours
Proportion of ahead-of-schedule change in flow rates in 24 hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start5 Jun 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extubation ReadinessStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Clinical Trial Center, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007715
- Sponsor's protocol ID
- 202502078RINA
- Status last verified
- Jul 2026
- First submitted
- 18 May 2025
- Last updated
- 20 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing High-flow Nasal Cannula Settings: Comparing Different Flow Approaches and Exploring Physiological Phenotyping With End-expiratory Lung Volume, Peak Tidal Inspiratory Flow and Oxygen Demand
- ClinicalTrials.gov ID
- NCT07007715
- Acronym / sponsor ID
- 202502078RINA
- Keywords
- flow rate, high flow nasal cannula, peak inspiratory flow, reintubation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 6 Jun 2025 (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.
The goal of this randomized trial is to compare four different flow-setting approaches for post-extubation use of high-flow nasal cannula (HFNC). Selecting the appropriate flow rate when initiating HFNC oxygen therapy is both crucial and challenging for clinicians, as the physiological benefits of HFNC depend significantly on the flow rate. To date, there are no guidelines or consensus on flow-rate setting and weaning for HFNC oxygen therapy.
The investigators hypothesized that physiological marker-guided flow setting using peak tidal inspiratory flow (PTIF) or PaO₂/FiO₂ ratios lead to better extubation outcomes as compared to empirical flow setting of 40 L/min or 60 L/min.
Participants will be randomly assigned to one of four study groups with different flow setting strategies summarized as follows: (1) Setting flow at 40 L/min, (2) Setting flow at 5 L/min above the peak tidal inspiratory flow, up to a maximum of 60 L/min. (3) Setting flow according to P/F ratio prior to extubation. Flow will be set at 60, 50 40 L/min if P/F ratio <250 mmHg, 250-300 mmHg and >300 mmHg, respectively. (4) Setting flow at 60 L/min.
Detailed description
High-flow nasal cannula (HFNC) is a promising intervention for post-extubation oxygen therapy, with the potential to improve oxygenation, increase end-expiratory lung volume (EELV), reduce the work of breathing, and lower the risk of reintubation. Selecting an appropriate flow rate when initiating HFNC therapy is both crucial and challenging for clinicians. Although the physiological benefits of HFNC depend significantly on the flow rate, arbitrarily applying higher flow rates without appropriate patient selection may increase the risk of barotrauma and patient discomfort. Currently, there are no established guidelines or consensus on flow-rate setting for HFNC therapy. Given the growing use of HFNC, determining the optimal flow-setting strategy is urgently needed to ensure both clinical efficacy and cost-effectiveness.
This 4-arm parallel-group randomized trial aims to compare four different flow-setting approaches for post-extubation use of HFNC in extubation outcomes. The individual flow-setting strategy for each study arm is summarized as follows: (1) Setting flow at 40 L/min, (2) Setting flow at 5 L/min above the peak tidal inspiratory flow, up to a maximum of 60 L/min. (3) Setting flow according to P/F ratio prior to extubation. Flow will be set at 60, 50 40 L/min if P/F ratio <250 mmHg, 250-300 mmHg and >300 mmHg, respectively. (4) Setting flow at 60 L/min. In addition, this study will incorporate measurements of peak tidal inspiratory flow and EELV to highlight the physiological characteristics of individual patients. These physiological measures may serve as both explanatory variables and potential predictors of flow responders. By examining the associations among flow responders, peak tidal inspiratory flow, pre-extubation oxygen demand, and changes in EELV, we aim to develop a comprehensive understanding of the mechanisms and key factors influencing flow responsiveness during post-extubation care with HFNC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Flow of 40L/min | Active comparator | Other: Flow of 40L/minSetting HFNC flow at 40 L/min |
| Peak tidal inspiratory flow (PTIF) guided | Experimental | Other: Peak tidal inspiratory flow (PTIF) guidedSetting HFNC flow at 5 L/min above the peak tidal inspiratory flow (PTIF), up to a maximum of 60 L/min. |
| PaO2/FiO2 ratio guided | Experimental | Other: PaO2/FiO2 ratio guidedSetting HFNC flow according to P/F ratio prior to extubation. Flow will be set at 60, 50 40 L/min if P/F ratio <250 mmHg, 250-300 mmHg and >300 mmHg, respectively. |
| Flow of 60L/min | Experimental | Other: Flow of 60L/minSetting HFNC flow at 60 L/min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Intubated and receiving mechanical ventilation for more than 24 hours
- Ready for planned extubation after passing a spontaneous breathing trial
- PaO2/FiO2 <350 mmHg on the day of extubation
Key exclusion criteria (7 listed)
- Age <18 years
- On do-not-reintubate code
- Pregnant women
- Having tracheostomies
- Infeasibility of using HFNC
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 |
|---|---|---|
| Flow of 40L/minSetting flow rate at 40L/min | Other | Flow of 40L/min |
| Peak tidal inspiratory flow (PTIF) guidedSetting HFNC flow at 5 L/min above the peak tidal inspiratory flow (PTIF), up to a maximum of 60 L/min. | Other | Peak tidal inspiratory flow (PTIF) guided |
| PaO2/FiO2 ratio guidedSetting HFNC flow according to P/F ratio prior to extubation. Flow will be set at 60, 50 40 L/min if P/F ratio <250 mmHg, 250-300 mmHg and >300 mmHg, respectively. | Other | PaO2/FiO2 ratio guided |
| Flow of 60L/minSetting flow rate at 60L/min | Other | Flow of 60L/min |
Primary outcome
A composite outcome of noninvasive ventilation (NIV) use or reintubation within five days after extubation
Time frame: 5 days
A single global test of significance to compare between-group difference in the composite outcome
6 secondary outcomes
Proportion of reintubation within five days after extubation
Time frame: 5 days
Proportion of NIV use within five days after extubation
Time frame: 5 days
28-day mortality
Time frame: 28 days
Change in PaO2/FiO2 ratio between 0 and 24th hour
Time frame: 24 hours
Change in arterial CO2 level (mmHg) between 0 and 24th hour
Time frame: 24 hours
Proportion of ahead-of-schedule change in flow rates in 24 hours
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flow of 40L/min, Peak tidal inspiratory flow (PTIF) guided and PaO2/FiO2 ratio guided in people with Extubation Readiness and Respiratory Failure With Hypoxia, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 20 Jul 2026. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sheng-Yuan Ruan, MD, PhD (886223123456, syruan@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite outcome of noninvasive ventilation (NIV) use or reintubation within five days after extubation (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2026.