Hypoxemic Respiratory FailureNCT04934163
Flow Rates of High-flow Nasal Cannula and Extubation Outcome
A study testing Flow rate setting of high-flow nasal cannula (initially 60L/min) and Flow rate setting of high-flow nasal cannula (initially 40L/min) in people with Hypoxemic Respiratory Failure, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypoxemic Respiratory Failure
- What is being tested?
- Flow rate setting of high-flow nasal cannula (initially 60L/min) and Flow rate setting of high-flow nasal cannula (initially 40L/min)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2021to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- < 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Flow Rates of Postextubation High-flow Nasal Cannula on Extubation Outcome: An Open-label, Randomized Controlled Trial
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.
Read the 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%.
- Conditions
- Hypoxemic Respiratory Failure
- Being tested
- Flow rate setting of high-flow nasal cannula (initially 60L/min), Flow rate setting of high-flow nasal cannula (initially 40L/min)
- Keywords
- high-flow nasal cannula, hypoxemic respiratory failure, oxygen therapy, postextubation respiratory failure
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow rate setting of high-flow nasal cannula (initially 60L/min)Other
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)Other
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%.
| Study group | Role | What they receive |
|---|---|---|
| 60 L/min arm | Experimental | The flow rate of HFNC(high-flow nasal cannula) is set as 60 L/min after extubation. Receives: Other: Flow rate setting of high-flow nasal cannula (initially 60L/min) |
| 40 L/min arm | Experimental | The flow rate of HFNC(high-flow nasal cannula) is set as 40 L/min after extubation. Receives: Other: Flow rate setting of high-flow nasal cannula (initially 40L/min) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hours after extubation
Secondary outcomes (10)
ICU mortality
Proportion of death in the ICU
Measured: ICU stay
In-hospital mortality
Proportion of death in the hospital
Measured: Hospital stay
28-day mortality
Proportion of death in 28 days after extubation
Measured: 28 days
Time to successful liberation from mechanical ventilation
Definition of successful liberation from mechanical ventilation: not requiring mechanical ventilation support for > 48 hours
Measured: 28 days
AUC(area under curve) of respiratory rate (0-24 hours)
measure respiratory rate every 2 hours during HFNC use
Measured: 24 hours
AUC of heart rate (0-24 hours)
measure heart rate every 2 hours during HFNC use
Measured: 24 hours
Change of PaO2/FiO2 ratio between 0 and 24th hour
PaO2: from arterial blood gas; FiO2:from HFNC setting
Measured: 24 hours
Change of arterial CO2 level(mmHg) between 0 and 24th hour
CO2 level
Measured: 24 hours
Proportion of respiratory acidosis (arterial blood gas: pH<7.35) in 24 hours
Respiratory acidosis
Measured: 24 hours
Proportion of Intolerance in 24 hours
subjective intolerance (Eg. temperature setting, flow setting, interface....)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start1 Sep 2021
- Primary completion28 Mar 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Hypoxemic Respiratory FailureStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Fu-Chang Tsai, MD, PhD, Study director, Research Ethics Committee of the National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934163
- Sponsor's protocol ID
- 202103054RINB
- Status last verified
- Aug 2023
- First submitted
- 14 Jun 2021
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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/rccm.201610-2153LE. No abstract available.
PubMed 28170290Saiphoklang 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.
PubMed 30286153Rochwerg 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 M, Carvalho C, Dessap-Mekontso A, Fraser J, Frat JP, Gomersall C, Grasselli G, Hernandez G, Jog S, Pesenti A, Riviello ED, Slutsky AS, Stapleton RD, Talmor D, Thille AW, Brochard L, Burns KEA. The role for high flow nasal cannula as a respiratory support strategy in adults: a clinical practice guideline. Intensive Care Med. 2020 Dec;46(12):2226-2237. doi: 10.1007/s00134-020-06312-y. Epub 2020 Nov 17.
PubMed 33201321Rochwerg 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 oxygen therapy for acute hypoxemic respiratory failure: a systematic review and meta-analysis. Intensive Care Med. 2019 May;45(5):563-572. doi: 10.1007/s00134-019-05590-5. Epub 2019 Mar 19.
PubMed 30888444Mauri 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.
PubMed 27997805Mauri 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 rates. Intensive Care Med. 2017 Oct;43(10):1453-1463. doi: 10.1007/s00134-017-4890-1. Epub 2017 Jul 31.
PubMed 28762180Mauri 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. Crit Care. 2018 May 9;22(1):120. doi: 10.1186/s13054-018-2039-4.
PubMed 29743098Maggiore 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 Respir Crit Care Med. 2014 Aug 1;190(3):282-8. doi: 10.1164/rccm.201402-0364OC.
PubMed 25003980Rittayamai 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.
PubMed 24046462Hernandez 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 Trial. JAMA. 2016 Apr 5;315(13):1354-61. doi: 10.1001/jama.2016.2711.
PubMed 26975498Hernandez 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 High-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Oct 18;316(15):1565-1574. doi: 10.1001/jama.2016.14194.
PubMed 27706464Fernandez 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 Intensive Care. 2017 Dec;7(1):47. doi: 10.1186/s13613-017-0270-9. Epub 2017 May 2.
PubMed 28466461Song 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.
PubMed 29069260Theerawit 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.jcrc.2020.09.031. Epub 2020 Sep 28.
PubMed 33012589Jing 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 pilot randomized controlled trial. Res Nurs Health. 2019 Jun;42(3):217-225. doi: 10.1002/nur.21942. Epub 2019 Mar 18.
PubMed 30887549
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Flow Rates of Postextubation High-flow Nasal Cannula on Extubation Outcome: An Open-label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04934163
- Acronym / sponsor ID
- 202103054RINB
- Conditions
- Hypoxemic Respiratory Failure
- Keywords
- high-flow nasal cannula, hypoxemic respiratory failure, oxygen therapy, postextubation respiratory failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 22 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 60 L/min arm | Experimental | Other: 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 | Experimental | Other: 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- < 20 years of ages
- refusal to re-intubation
- with terminal cancer
- pregnant women
- with a tracheal stoma or tracheostomy tube in situ
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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%. | Other | 60 L/min arm |
| 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%. | Other | 40 L/min arm |
Primary outcome
A composite outcome of NIV(non-invasive ventilation) use or reintubation in 48 hours
Time frame: 48 hours after extubation
Proportion of patients require NIV(non-invasive ventilation) support or reintubation
10 secondary outcomes
ICU mortality
Time frame: ICU stay
In-hospital mortality
Time frame: Hospital stay
28-day mortality
Time frame: 28 days
Time to successful liberation from mechanical ventilation
Time frame: 28 days
AUC(area under curve) of respiratory rate (0-24 hours)
Time frame: 24 hours
AUC of heart rate (0-24 hours)
Time frame: 24 hours
Change of PaO2/FiO2 ratio between 0 and 24th hour
Time frame: 24 hours
Change of arterial CO2 level(mmHg) between 0 and 24th hour
Time frame: 24 hours
Proportion of respiratory acidosis (arterial blood gas: pH<7.35) in 24 hours
Time frame: 24 hours
Proportion of Intolerance in 24 hours
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Results publication: PubMed 28170290Ruan 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/rccm.201610-2153LE. No abstract available.
- Results publication: PubMed 30286153Saiphoklang 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.
- Results publication: PubMed 33201321Rochwerg 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 M, Carvalho C, Dessap-Mekontso A, Fraser J, Frat JP, Gomersall C, Grasselli G, Hernandez G, Jog S, Pesenti A, Riviello ED, Slutsky AS, Stapleton RD, Talmor D, Thille AW, Brochard L, Burns KEA. The role for high flow nasal cannula as a respiratory support strategy in adults: a clinical practice guideline. Intensive Care Med. 2020 Dec;46(12):2226-2237. doi: 10.1007/s00134-020-06312-y. Epub 2020 Nov 17.
- Results publication: PubMed 30888444Rochwerg 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 oxygen therapy for acute hypoxemic respiratory failure: a systematic review and meta-analysis. Intensive Care Med. 2019 May;45(5):563-572. doi: 10.1007/s00134-019-05590-5. Epub 2019 Mar 19.
- Results publication: PubMed 27997805Mauri 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.
- Results publication: PubMed 28762180Mauri 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 rates. Intensive Care Med. 2017 Oct;43(10):1453-1463. doi: 10.1007/s00134-017-4890-1. Epub 2017 Jul 31.
- Results publication: PubMed 29743098Mauri 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. Crit Care. 2018 May 9;22(1):120. doi: 10.1186/s13054-018-2039-4.
- Results publication: PubMed 25003980Maggiore 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 Respir Crit Care Med. 2014 Aug 1;190(3):282-8. doi: 10.1164/rccm.201402-0364OC.
- Results publication: PubMed 24046462Rittayamai 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.
- Results publication: PubMed 26975498Hernandez 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 Trial. JAMA. 2016 Apr 5;315(13):1354-61. doi: 10.1001/jama.2016.2711.
- Results publication: PubMed 27706464Hernandez 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 High-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Oct 18;316(15):1565-1574. doi: 10.1001/jama.2016.14194.
- Results publication: PubMed 28466461Fernandez 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 Intensive Care. 2017 Dec;7(1):47. doi: 10.1186/s13613-017-0270-9. Epub 2017 May 2.
- Individual participant dataSharing planned: No
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Acute Respiratory Failure
RecruitingPhase 2
Interleukin-6 Guided Treatment With Dexamethasone or Tocilizumab in Patients Hospitalized With Acute Respiratory Symptoms - a Feasibility Study
Acute Hypoxemic Respiratory Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Fu-Chang Tsai, MD, PhD study director
Research Ethics Committee of the National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flow rate setting of high-flow nasal cannula (initially 60L/min) and Flow rate setting of high-flow nasal cannula (initially 40L/min) in people with Hypoxemic Respiratory Failure, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite outcome of NIV(non-invasive ventilation) use or reintubation in 48 hours (time frame: 48 hours after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04934163, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.