NCT07007715

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P75+ for not_applicable

Timeline
26mo left

Started Jun 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress30%
Jun 2025Jun 2028

First Submitted

Initial submission to the registry

May 18, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

June 5, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 6, 2025

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

June 6, 2025

Status Verified

May 1, 2025

Enrollment Period

3.1 years

First QC Date

May 18, 2025

Last Update Submit

June 5, 2025

Conditions

Extubation ReadinessRespiratory Failure With Hypoxia

Keywords

flow ratehigh flow nasal cannulapeak inspiratory flowreintubation

Outcome Measures

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

    5 days

Secondary Outcomes (6)

  • Proportion of reintubation within five days after extubation

    5 days

  • Proportion of NIV use within five days after extubation

    5 days

  • 28-day mortality

    28 days

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

    24 hours

  • Change in arterial CO2 level (mmHg) between 0 and 24th hour

    24 hours

  • +1 more secondary outcomes

Study Arms (4)

Flow of 40L/min

ACTIVE COMPARATOR

Setting HFNC flow at 40 L/min

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.

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.

Other: PaO2/FiO2 ratio guided

Flow of 60L/min

EXPERIMENTAL

Setting HFNC flow at 60 L/min

Other: Flow of 60L/min

Interventions

Flow of 40L/minOTHER

Setting flow rate at 40L/min

Flow of 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.

Peak tidal inspiratory flow (PTIF) guided
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.

PaO2/FiO2 ratio guided
Flow of 60L/minOTHER

Setting flow rate at 60L/min

Flow of 60L/min

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Central Study Contacts

Sheng-Yuan Ruan, MD, PhD

CONTACT

886223123456syruan@ntu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sheng-Yuan Ruan, MD

Study Record Dates

First Submitted

May 18, 2025

First Posted

June 6, 2025

Study Start

June 5, 2025

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

June 6, 2025

Record last verified: 2025-05

Locations

TW(1)