An interventional study of Flow of 40L/min and Peak tidal inspiratory flow (PTIF) guided in Extubation Readiness and Respiratory Failure With Hypoxia, sponsored by National Taiwan University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
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.
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.
National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Setting HFNC flow at 40 L/min
Other: Flow of 40L/min
Setting 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
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.
Other: PaO2/FiO2 ratio guided
Setting HFNC flow at 60 L/min
Other: Flow of 60L/min
Setting flow rate at 40L/min
Setting HFNC flow at 5 L/min above the peak tidal inspiratory flow (PTIF), up to a maximum of 60 L/min.
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.
Setting flow rate at 60L/min
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
Time frame: 5 days
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
Time frame: 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.
Time frame: 5 days
28-day mortality
28-day mortality
Time frame: 28 days
Change in PaO2/FiO2 ratio between 0 and 24th hour
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
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
Proportion of ahead-of-schedule change in flow rates in 24 hours
Time frame: 24 hours
Plan to share: Undecided
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National Taiwan University Hospital