Identifying the Best Flow Setting Strategy for High-Flow Nasal Cannula

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Taiwan University Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Flow of 40L/min

    Other intervention

    Setting flow rate at 40L/min

  • Peak tidal inspiratory flow (PTIF) guided

    Other intervention

    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 guided

    Other intervention

    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/min

    Other intervention

    Setting flow rate at 60L/min

Treatment groups

480 Participants
are divided into 4 treatment groups
Group A: Flow of 40L/minActive comparator 1 intervention
Group B: Peak tidal inspiratory flow (PTIF) guidedExperimental treatment 1 intervention
Group C: PaO2/FiO2 ratio guidedExperimental treatment 1 intervention
Group D: Flow of 60L/minExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

28-day mortality

28-day mortality

Time frame
28 days
4

Change in PaO2/FiO2 ratio between 0 and 24th hour

Change in PaO2/FiO2 ratio between 0 and 24th hour

Time frame
24 hours

Other outcomes

Sponsors and contacts

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