An interventional study of Flow rate setting of high-flow nasal cannula (initially 60L/min) and Flow rate setting of high-flow nasal cannula (initially 40L/min) in Hypoxemic Respiratory Failure, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-05-10.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Supportive care
This is a single-center, open-label, randomized controlled trial to evaluate the effect of high-flow nasal cannula with a flow rate of 60 L/min versus 40 L/min after planned extubationon on a composite outcome of reintubation and use of NIV.
This is a single-center, open-label, randomized controlled trial to evaluate the effect of high-flow nasal cannula with a flow rate of 60 L/min versus 40 L/min after planned extubationon on a composite outcome of reintubation and use of NIV in patients who are intubated for hypoxemic respiratory failure.
[Study Procedures] Set flow rates of HFNC The flow rates of HFNC(high-flow nasal cannula) are set as 40 L/min and 60 L/min, respectively in the two trial groups. FiO2 was down-titrated to the minimal level to keep SO2 ≥ 92%. After that, the flow rate setting is fixed for 24hrs +/- 6 hrs in the two groups. After that, the flow rate setting in both groups would be tapered to 30 L/min and would be kept for 12 hours. Then, HFNC would be changed to conventional oxygen therapy to keep SpO2≥ 92%.
[Outcome Measures] To increase the statistical power of this pilot trial, we used a composite outcome of NIV use and or reintubation in 48 hours for the primary endpoint. Secondary endpoints include mortality of different time points, physiological parameters(respiratory rate, heart rate), ventilation/oxygenation data(PaO2/FiO2 ratio, pH) and patient comfort. Exploratory endpoints include comparison between different flow rate settings.
[Primary endpoint] We hypothesized that higher flow setting of HFNC can reduce work of breathing and can increase washout of dead space, which could result in lower re-intubation rate and lower NIV use rate after planned extubation in hypoxemic patients. The primary endpoint is a composite outcome of NIV use or reintubation in 48 hours between two groups of different flow rates.
[Secondary endpoints] ICU mortality In-hospital mortality 28-day mortality Time to successful liberation from mechanical ventilation AUC(area under curve) of respiratory rate (0-24 hours) AUC of heart rate (0-24 hours) PaO2/FiO2 ratio at 4 and 24 hours Change of arterial CO2 level(mmHg) at 4 and 24 hours Proportion of respiratory acidosis (arterial blood gas: pH\<7.35) at 4 and 24 hours Proportion of Intolerance (up titration of flow or/and FiO2; down titration of flow) in 24 hours
[Sample size] The event rate of primary endpoint, defined as a composite outcome of NIV use and or reintubation in 48 hours, was assumed to be 40% in the 40 L/min arms and 20% in the 60 L/min. We estimated that with a sample of 180 patients, the study would have 80% power to detect a 20% absolute reduction in proportion of composite outcomes, at a two-sided type I error rate of 5%.
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's enrollment of 180 is above the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.
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Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
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Exclusion Criteria:
The flow rate of HFNC(high-flow nasal cannula) is set as 60 L/min after extubation.
Other: Flow rate setting of high-flow nasal cannula (initially 60L/min)
The flow rate of HFNC(high-flow nasal cannula) is set as 40 L/min after extubation.
Other: Flow rate setting of high-flow nasal cannula (initially 40L/min)
The flow rates of HFNC(high-flow nasal cannula) is set as 60L/min(temperature:34°C). Initial FiO2 is 100%, which would be titrated down to the minimal level to keep SpO2 ≥ 92% within 30 minutes after extubation. After that, the flow rate setting is fixed for 24hrs +/- 6 hrs; then, is tapered to 30 L/min and kept for 12 more hours. Afterwards, HFNC would be changed to conventional oxygen therapy to keep SpO2≥ 92%.
The flow rates of HFNC(high-flow nasal cannula) is set as 40L/min(temperature:34°C). Initial FiO2 is 100%, which would be titrated down to the minimal level to keep SpO2 ≥ 92% within 30 minutes after extubation. After that, the flow rate setting is fixed for 24hrs +/- 6 hrs; then, is tapered to 30 L/min and kept for 12 more hours. Afterwards, HFNC would be changed to conventional oxygen therapy to keep SpO2≥ 92%.
A composite outcome of NIV(non-invasive ventilation) use or reintubation in 48 hours
Proportion of patients require NIV(non-invasive ventilation) support or reintubation
Time frame: 48 hours after extubation
ICU mortality
Proportion of death in the ICU
Time frame: ICU stay
In-hospital mortality
Proportion of death in the hospital
Time frame: Hospital stay
28-day mortality
Proportion of death in 28 days after extubation
Time frame: 28 days
Time to successful liberation from mechanical ventilation
Definition of successful liberation from mechanical ventilation: not requiring mechanical ventilation support for \> 48 hours
Time frame: 28 days
AUC(area under curve) of respiratory rate (0-24 hours)
measure respiratory rate every 2 hours during HFNC use
Time frame: 24 hours
AUC of heart rate (0-24 hours)
measure heart rate every 2 hours during HFNC use
Time frame: 24 hours
Change of PaO2/FiO2 ratio between 0 and 24th hour
PaO2: from arterial blood gas; FiO2:from HFNC setting
Time frame: 24 hours
Change of arterial CO2 level(mmHg) between 0 and 24th hour
CO2 level
Time frame: 24 hours
Proportion of respiratory acidosis (arterial blood gas: pH<7.35) in 24 hours
Respiratory acidosis
Time frame: 24 hours
Proportion of Intolerance in 24 hours
subjective intolerance (Eg. temperature setting, flow setting, interface....)
Time frame: 24 hours
Plan to share: No
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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National Taiwan University Hospital