About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Age <18 years
On do-not-reintubate code
Pregnant women
Having tracheostomies
Trial design
Parallel
Treatments tested in this trial
Flow of 40L/min
Other interventionSetting flow rate at 40L/min
Peak tidal inspiratory flow (PTIF) guided
Other interventionSetting 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
Other interventionSetting 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
Other interventionSetting flow rate at 60L/min
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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
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.
28-day mortality
28-day mortality
Change in PaO2/FiO2 ratio between 0 and 24th hour
Change in PaO2/FiO2 ratio between 0 and 24th hour
Sponsors and contacts
Click on the lead sponsor to view all of their trials.