Flow Rates of High-flow Nasal Cannula and Extubation Outcome

Not Applicable

Completed

• Conditions: Hypoxemic Respiratory Failure
• Interventions: Other: Flow rate setting of high-flow nasal cannula (initially 60L/min); Other: Flow rate setting of high-flow nasal cannula (initially 40L/min)

• Registration Number: NCT04934163
• Lead Sponsor: National Taiwan University Hospital

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%.

Study Timeline

• Study First Submitted: 2021-06-14
• Study First Submitted QC: 2021-06-14
• Study First Posted: 2021-06-22
• Study Start: 2021-09-01
• Primary Completion: 2023-03-28
• Study Completion: 2023-04-30
• Status Verified: 2023-08
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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)

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
60 L/min arm	Flow rate setting of high-flow nasal cannula (initially 60L/min)	The flow rate of HFNC(high-flow nasal cannula) is set as 60 L/min after extubation.
40 L/min arm	Flow rate setting of high-flow nasal cannula (initially 40L/min)	The flow rate of HFNC(high-flow nasal cannula) is set as 40 L/min after extubation.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Proportion of respiratory acidosis (arterial blood gas: pH<7.35) in 24 hours	24 hours	Respiratory acidosis
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
Change of arterial CO2 level(mmHg) between 0 and 24th hour	24 hours	CO2 level
AUC of heart rate (0-24 hours)	24 hours	measure heart rate every 2 hours during HFNC use
Change of PaO2/FiO2 ratio between 0 and 24th hour	24 hours	PaO2: from arterial blood gas; FiO2:from HFNC setting
Proportion of Intolerance in 24 hours	24 hours	subjective intolerance (Eg. temperature setting, flow setting, interface....)

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan