Clinical trial NCT04934163: Flow Rates of High-flow Nasal Cannula and Extubation Outcome
Official title: Effect of Flow Rates of Postextubation High-flow Nasal Cannula on Extubation Outcome: An Open-label, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxemic Respiratory Failure
Keywords: high-flow nasal cannula
hypoxemic respiratory failure
oxygen therapy
postextubation respiratory failure
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 180
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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%.

Eligibility criteria: Inclusion Criteria:

* invasive mechanical ventilation \> 48 hours
* acute hypoxemic respiratory failure(PaO2/FiO2 \< 300 mmHg) as a main cause of invasive mechanical ventilation.
* planned extubation \& already passed a spontaneous breathing trial (SBT)

Exclusion Criteria:

* \< 20 years of ages
* refusal to re-intubation
* with terminal cancer
* pregnant women
* with a tracheal stoma or tracheostomy tube in situ
* not feasible for high-flow nasal cannula(decided by the primary care team)
* must required to use non-invasive ventilation immediately after extubation (decided by the primary care team)

Primary outcomes:
measure: A composite outcome of NIV(non-invasive ventilation) use or reintubation in 48 hours
timeFrame: 48 hours after extubation
Secondary outcomes:
measure: ICU mortality
timeFrame: ICU stay
measure: In-hospital mortality
timeFrame: Hospital stay
measure: 28-day mortality
timeFrame: 28 days
measure: Time to successful liberation from mechanical ventilation
timeFrame: 28 days
measure: AUC(area under curve) of respiratory rate (0-24 hours)
timeFrame: 24 hours
measure: AUC of heart rate (0-24 hours)
timeFrame: 24 hours
measure: Change of PaO2/FiO2 ratio between 0 and 24th hour
timeFrame: 24 hours
measure: Change of arterial CO2 level(mmHg) between 0 and 24th hour
timeFrame: 24 hours
measure: Proportion of respiratory acidosis (arterial blood gas: pH<7.35) in 24 hours
timeFrame: 24 hours
measure: Proportion of Intolerance in 24 hours
timeFrame: 24 hours
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Research Ethics Committee of the National Taiwan University Hospital
name: Daniel Fu-Chang Tsai, MD, PhD
role: STUDY_DIRECTOR
References:
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