Best starting flow for high-flow nasal cannula after extubation
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
This trial tests four different ways of setting the initial flow on high-flow nasal cannula to see if one approach reduces breathing problems or the need to be put back on a ventilator after adults are extubated.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 480 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Trial ID | NCT07007715 on ClinicalTrials.gov |
What this trial studies
This is a single-center, randomized, 4-arm parallel-group trial comparing four HFNC flow-setting strategies after planned extubation: fixed 40 L/min, fixed 60 L/min, a peak tidal inspiratory flow (PTIF)-guided setting (5 L/min above PTIF up to 60 L/min), and a PaO2/FiO2 (P/F)-guided tiered flow (60/50/40 L/min by P/F ranges). Eligible adult patients have been mechanically ventilated >24 hours, passed a spontaneous breathing trial, and have PaO2/FiO2 <350 mmHg at extubation. The trial will collect physiological measures including PTIF and end-expiratory lung volume (EELV) and track extubation outcomes such as need for reintubation. The goal is to determine whether physiology-guided or simple fixed-flow approaches lead to better post-extubation results and tolerability.
Who should consider this trial
Good fit: Adults intubated and mechanically ventilated for more than 24 hours who have passed a spontaneous breathing trial and are ready for planned extubation with PaO2/FiO2 <350 mmHg are ideal candidates.
Not a fit: Patients with tracheostomies, those planned to receive preventive NIV after extubation, those with do-not-reintubate orders, pregnant patients, children, or anyone for whom HFNC is infeasible are unlikely to qualify or benefit from this protocol.
Why it matters
Potential benefit: If successful, the results could help clinicians choose an initial HFNC flow that lowers reintubation risk, improves breathing comfort, and avoids unnecessary high flows.
How similar studies have performed: Previous studies show HFNC can improve oxygenation and reduce work of breathing versus conventional oxygen, but randomized comparisons of specific flow-setting strategies like PTIF- or P/F-guided approaches are limited, so this question is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Sheng-Yuan Ruan, MD, PhD
- Email: syruan@ntu.edu.tw
- Phone: 886223123456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.