Flow Rates of High-flow Nasal Cannula and Extubation Outcome
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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. Initial FiO2 setting is 100%, which would be titrated down to the minimal level to keep SO2 ≥ 92% within 30 minutes after extubation. 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 at 4 and 24 hours Patient comfort (measured by Visual Analog Scale) at 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 25% in the 60 L/min. We estimated that with a sample of 165 patients, the study would have 80% power to detect a 15% absolute reduction in proportion of composite outcomes, at a two-sided type I error rate of 5%.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 60 L/min arm 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 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%.
|
| Experimental: 40 L/min arm 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 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%.
|
Outcome Measures
Primary Outcome Measures
- A composite outcome of NIV(non-invasive ventilation) use or reintubation in 48 hours [48 hours after extubation]
Proportion of patients require NIV(non-invasive ventilation) support or reintubation
Secondary Outcome Measures
- ICU mortality [ICU stay]
Proportion of death in the ICU
- In-hospital mortality [Hospital stay]
Proportion of death in the hospital
- 28-day mortality [28 days]
Proportion of death in 28 days after extubation
- Time to successful liberation from mechanical ventilation [28 days]
Definition of successful liberation from mechanical ventilation: not requiring mechanical ventilation support for > 48 hours
- AUC(area under curve) of respiratory rate (0-24 hours) [24 hours]
measure respiratory rate every 2 hours during HFNC use
- AUC of heart rate (0-24 hours) [24 hours]
measure heart rate every 2 hours during HFNC use
- PaO2/FiO2 ratio at 4 and 24 hours [24 hours]
PaO2: from arterial blood gas; FiO2:from HFNC setting
- Change of arterial CO2 level(mmHg) at 4 and 24 hours [24 hours]
CO2 level
- Proportion of respiratory acidosis (arterial blood gas: pH<7.35) at 4 and 24 hours [24 hours]
Respiratory acidosis
- Proportion of Intolerance at 4 and 24 hours [24 hours]
subjective intolerance (Eg. temperature setting, flow setting, interface....)
- Patient comfort score at 24 hour [24 hours]
7-point scale which 7 indicates most comfortable and 1 indicates least comfortable
Eligibility Criteria
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
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not feasible for high-flow nasal cannula(decided by the primary care team)
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must required to use non-invasive ventilation immediately after extubation (decided by the primary care team)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Taiwan University Hospital | Taipei | Taiwan | 10002 |
Sponsors and Collaborators
- National Taiwan University Hospital
Investigators
- Study Director: Daniel Fu-Chang Tsai, MD, PhD, Research Ethics Committee of the National Taiwan University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 202103054RINB