Flow Rates of High-flow Nasal Cannula and Extubation Outcome

Hypoxemic Respiratory Failure Clinical Trial

Official title:

Effect of Flow Rates of Postextubation High-flow Nasal Cannula on Extubation Outcome: An Open-label, Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04934163
• Other study ID #: 202103054RINB
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: August 2023
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: April 30, 2023
• Est. primary completion date: March 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hypoxemic Respiratory Failure
• Respiratory Insufficiency

Intervention

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%.
• 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%.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (15)

Fernandez R, Subira C, Frutos-Vivar F, Rialp G, Laborda C, Masclans JR, Lesmes A, Panadero L, Hernandez G. High-flow nasal cannula to prevent postextubation respiratory failure in high-risk non-hypercapnic patients: a randomized multicenter trial. Ann Int — View Citation

Hernandez G, Vaquero C, Colinas L, Cuena R, Gonzalez P, Canabal A, Sanchez S, Rodriguez ML, Villasclaras A, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in — View Citation

Hernandez G, Vaquero C, Gonzalez P, Subira C, Frutos-Vivar F, Rialp G, Laborda C, Colinas L, Cuena R, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Conventional Oxygen Therapy on Reintubation in Low-Risk Patients: A Randomized Clinical — View Citation

Jing G, Li J, Hao D, Wang T, Sun Y, Tian H, Fu Z, Zhang Y, Wang X. Comparison of high flow nasal cannula with noninvasive ventilation in chronic obstructive pulmonary disease patients with hypercapnia in preventing postextubation respiratory failure: A pi — View Citation

Maggiore SM, Idone FA, Vaschetto R, Festa R, Cataldo A, Antonicelli F, Montini L, De Gaetano A, Navalesi P, Antonelli M. Nasal high-flow versus Venturi mask oxygen therapy after extubation. Effects on oxygenation, comfort, and clinical outcome. Am J Respi — View Citation

Mauri T, Alban L, Turrini C, Cambiaghi B, Carlesso E, Taccone P, Bottino N, Lissoni A, Spadaro S, Volta CA, Gattinoni L, Pesenti A, Grasselli G. Optimum support by high-flow nasal cannula in acute hypoxemic respiratory failure: effects of increasing flow — View Citation

Mauri T, Galazzi A, Binda F, Masciopinto L, Corcione N, Carlesso E, Lazzeri M, Spinelli E, Tubiolo D, Volta CA, Adamini I, Pesenti A, Grasselli G. Impact of flow and temperature on patient comfort during respiratory support by high-flow nasal cannula. Cri — View Citation

Mauri T, Turrini C, Eronia N, Grasselli G, Volta CA, Bellani G, Pesenti A. Physiologic Effects of High-Flow Nasal Cannula in Acute Hypoxemic Respiratory Failure. Am J Respir Crit Care Med. 2017 May 1;195(9):1207-1215. doi: 10.1164/rccm.201605-0916OC. — View Citation

Rittayamai N, Tscheikuna J, Rujiwit P. High-flow nasal cannula versus conventional oxygen therapy after endotracheal extubation: a randomized crossover physiologic study. Respir Care. 2014 Apr;59(4):485-90. doi: 10.4187/respcare.02397. Epub 2013 Sep 17. — View Citation

Rochwerg B, Einav S, Chaudhuri D, Mancebo J, Mauri T, Helviz Y, Goligher EC, Jaber S, Ricard JD, Rittayamai N, Roca O, Antonelli M, Maggiore SM, Demoule A, Hodgson CL, Mercat A, Wilcox ME, Granton D, Wang D, Azoulay E, Ouanes-Besbes L, Cinnella G, Rauseo — View Citation

Rochwerg B, Granton D, Wang DX, Helviz Y, Einav S, Frat JP, Mekontso-Dessap A, Schreiber A, Azoulay E, Mercat A, Demoule A, Lemiale V, Pesenti A, Riviello ED, Mauri T, Mancebo J, Brochard L, Burns K. High flow nasal cannula compared with conventional oxyg — View Citation

Ruan SY, Teng NC, Wu HD, Tsai SL, Wang CY, Wu CP, Yu CJ, Chen L. Durability of Weaning Success for Liberation from Invasive Mechanical Ventilation: An Analysis of a Nationwide Database. Am J Respir Crit Care Med. 2017 Sep 15;196(6):792-795. doi: 10.1164/r — View Citation

Saiphoklang N, Auttajaroon J. Incidence and outcome of weaning from mechanical ventilation in medical wards at Thammasat University Hospital. PLoS One. 2018 Oct 4;13(10):e0205106. doi: 10.1371/journal.pone.0205106. eCollection 2018. — View Citation

Song HZ, Gu JX, Xiu HQ, Cui W, Zhang GS. The value of high-flow nasal cannula oxygen therapy after extubation in patients with acute respiratory failure. Clinics (Sao Paulo). 2017 Oct;72(9):562-567. doi: 10.6061/clinics/2017(09)07. — View Citation

Theerawit P, Natpobsuk N, Petnak T, Sutherasan Y. The efficacy of the WhisperFlow CPAP system versus high flow nasal cannula in patients at risk for postextubation failure: A Randomized controlled trial. J Crit Care. 2021 Jun;63:117-123. doi: 10.1016/j.jc — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	48 hours after extubation
Secondary	ICU mortality	Proportion of death in the ICU	ICU stay
Secondary	In-hospital mortality	Proportion of death in the hospital	Hospital stay
Secondary	28-day mortality	Proportion of death in 28 days after extubation	28 days
Secondary	Time to successful liberation from mechanical ventilation	Definition of successful liberation from mechanical ventilation: not requiring mechanical ventilation support for > 48 hours	28 days
Secondary	AUC(area under curve) of respiratory rate (0-24 hours)	measure respiratory rate every 2 hours during HFNC use	24 hours
Secondary	AUC of heart rate (0-24 hours)	measure heart rate every 2 hours during HFNC use	24 hours
Secondary	Change of PaO2/FiO2 ratio between 0 and 24th hour	PaO2: from arterial blood gas; FiO2:from HFNC setting	24 hours
Secondary	Change of arterial CO2 level(mmHg) between 0 and 24th hour	CO2 level	24 hours
Secondary	Proportion of respiratory acidosis (arterial blood gas: pH<7.35) in 24 hours	Respiratory acidosis	24 hours
Secondary	Proportion of Intolerance in 24 hours	subjective intolerance (Eg. temperature setting, flow setting, interface....)	24 hours