HFNC flow set at 2 times of patient peak tidal inspiratory flow for Hypoxemic Respiratory Failure
Phase-Based Progress Estimates
Effectiveness
Safety
Hypoxemic Respiratory FailureHFNC flow set at 2 times of patient peak tidal inspiratory flow - Other
Study Summary
This trial is exploring the correlation between a patient's peak tidal inspiratory flow pre and post extubation, as well as their response to different high-flow nasal cannula flows.
Eligible Conditions
- Hypoxemic Respiratory Failure
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: 20 minutes after each flow setting
20 minutes after each flow setting
End-expiratory lung volume assessed by EIT
SpO2/FIO2
self-evaluated comfort
Trial Safety
Safety Progress
Trial Design
4 Treatment Groups
HFNC flow set at patient peak tidal inspiratory flow
1 of 4
HFNC flow set at 2 times of patient peak tidal inspiratory flow
1 of 4
HFNC flow set at 1.67 times of patient peak tidal inspiratory flow
1 of 4
HFNC flow set at 1.33 times of patient peak tidal inspiratory flow
1 of 4
Active Control
Experimental Treatment
28 Total Participants · 4 Treatment Groups
Primary Treatment: HFNC flow set at 2 times of patient peak tidal inspiratory flow · No Placebo Group · N/A
HFNC flow set at 2 times of patient peak tidal inspiratory flow
Other
Experimental Group · 1 Intervention: HFNC flow set at 2 times of patient peak tidal inspiratory flow · Intervention Types: OtherHFNC flow set at 1.67 times of patient peak tidal inspiratory flow
Other
Experimental Group · 1 Intervention: HFNC flow set at 1.67 times of patient peak tidal inspiratory flow · Intervention Types: OtherHFNC flow set at 1.33 times of patient peak tidal inspiratory flow
Other
Experimental Group · 1 Intervention: HFNC flow set at 1.33 times of patient peak tidal inspiratory flow · Intervention Types: OtherHFNC flow set at patient peak tidal inspiratory flow
Other
ActiveComparator Group · 1 Intervention: HFNC flow set at patient peak tidal inspiratory flow · Intervention Types: OtherTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 20 minutes after each flow setting
Who is running the clinical trial?
Hospital Vall d'HebronOTHER
74 Previous Clinical Trials
60,109 Total Patients Enrolled
Rush University Medical CenterLead Sponsor
390 Previous Clinical Trials
153,506 Total Patients Enrolled
Jie Li, PhDPrincipal InvestigatorRush University
9 Previous Clinical Trials
408 Total Patients Enrolled
Eligibility Criteria
Age 18 - 90 · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Frat, Jean-Pierre, Arnaud W. Thille, Alain Mercat, Christophe Girault, Stéphanie Ragot, Sébastien Perbet, Gwénael Prat, et al.. 2015. “High-flow Oxygen Through Nasal Cannula in Acute Hypoxemic Respiratory Failure”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1503326.
- Butt, Sophia, Laura Pistidda, Leda Floris, Corrado Liperi, Francesco Vasques, Guy Glover, Nicholas A. Barrett, et al.. 2021. “Initial Setting of High-flow Nasal Oxygen Post Extubation Based on Mean Inspiratory Flow During a Spontaneous Breathing Trial”. Journal of Critical Care. Elsevier BV. doi:10.1016/j.jcrc.2020.12.022.
- Li, Jie, Guoqiang Jing, and J Brady Scott. 2020. “Year in Review 2019: High-flow Nasal Cannula Oxygen Therapy for Adult Subjects”. Respiratory Care. Daedalus Enterprises. doi:10.4187/respcare.07663.
- Rochwerg, B., D. Granton, D. X. Wang, Y. Helviz, S. Einav, J. P. Frat, A. Mekontso-Dessap, et al.. 2019. “High Flow Nasal Cannula Compared with Conventional Oxygen Therapy for Acute Hypoxemic Respiratory Failure: A Systematic Review and Meta-analysis”. Intensive Care Medicine. Springer Science and Business Media LLC. doi:10.1007/s00134-019-05590-5.
- Mauri, Tommaso, Laura Alban, Cecilia Turrini, Barbara Cambiaghi, Eleonora Carlesso, Paolo Taccone, Nicola Bottino, et al.. 2017. “Optimum Support by High-flow Nasal Cannula in Acute Hypoxemic Respiratory Failure: Effects of Increasing Flow Rates”. Intensive Care Medicine. Springer Science and Business Media LLC. doi:10.1007/s00134-017-4890-1.
- Yasuda, Hideto, Hiromu Okano, Takuya Mayumi, Chihiro Narita, Yu Onodera, Masaki Nakane, and Nobuaki Shime. 2021. “Post-extubation Oxygenation Strategies in Acute Respiratory Failure: A Systematic Review and Network Meta-analysis”. Critical Care. Springer Science and Business Media LLC. doi:10.1186/s13054-021-03550-4.
- Hernández, Gonzalo, Concepción Vaquero, Paloma González, Carles Subira, Fernando Frutos-Vivar, Gemma Rialp, Cesar Laborda, Laura Colinas, Rafael Cuena, and Rafael Fernández. 2016. “Effect of Postextubation High-flow Nasal Cannula Vs Conventional Oxygen Therapy on Reintubation in Low-risk Patients”. Jama. American Medical Association (AMA). doi:10.1001/jama.2016.2711.
- Mauri, Tommaso, Elena Spinelli, Francesca Dalla Corte, Eleonora Scotti, Cecilia Turrini, Marta Lazzeri, Laura Alban, et al.. 2019. “Noninvasive Assessment of Airflows by Electrical Impedance Tomography in Intubated Hypoxemic Patients: An Exploratory Study”. Annals of Intensive Care. Springer Science and Business Media LLC. doi:10.1186/s13613-019-0560-5.
- Hernández, Gonzalo, Concepción Vaquero, Laura Colinas, Rafael Cuena, Paloma González, Alfonso Canabal, Susana Sanchez, Maria Luisa Rodriguez, Ana Villasclaras, and Rafael Fernández. 2016. “Effect of Postextubation High-flow Nasal Cannula Vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in High-risk Patients”. Jama. American Medical Association (AMA). doi:10.1001/jama.2016.14194.
- Hernández, Gonzalo, Concepción Vaquero, Laura Colinas, Rafael Cuena, Paloma González, Alfonso Canabal, Susana Sanchez, Maria Luisa Rodriguez, Ana Villasclaras, and Rafael Fernández. 2016. “Effect of Postextubation High-flow Nasal Cannula Vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in High-risk Patients”. Jama. American Medical Association (AMA). doi:10.1001/jama.2016.14194.
- Frat, Jean-Pierre, Arnaud W. Thille, Alain Mercat, Christophe Girault, Stéphanie Ragot, Sébastien Perbet, Gwénael Prat, et al.. 2015. “High-flow Oxygen Through Nasal Cannula in Acute Hypoxemic Respiratory Failure”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1503326.
- Hernández, Gonzalo, Concepción Vaquero, Paloma González, Carles Subira, Fernando Frutos-Vivar, Gemma Rialp, Cesar Laborda, Laura Colinas, Rafael Cuena, and Rafael Fernández. 2016. “Effect of Postextubation High-flow Nasal Cannula Vs Conventional Oxygen Therapy on Reintubation in Low-risk Patients”. Jama. American Medical Association (AMA). doi:10.1001/jama.2016.2711.
- Rochwerg, B., D. Granton, D. X. Wang, Y. Helviz, S. Einav, J. P. Frat, A. Mekontso-Dessap, et al.. 2019. “High Flow Nasal Cannula Compared with Conventional Oxygen Therapy for Acute Hypoxemic Respiratory Failure: A Systematic Review and Meta-analysis”. Intensive Care Medicine. Springer Science and Business Media LLC. doi:10.1007/s00134-019-05590-5.
- Mauri, Tommaso, Laura Alban, Cecilia Turrini, Barbara Cambiaghi, Eleonora Carlesso, Paolo Taccone, Nicola Bottino, et al.. 2017. “Optimum Support by High-flow Nasal Cannula in Acute Hypoxemic Respiratory Failure: Effects of Increasing Flow Rates”. Intensive Care Medicine. Springer Science and Business Media LLC. doi:10.1007/s00134-017-4890-1.
- Hernández, Gonzalo, Concepción Vaquero, Paloma González, Carles Subira, Fernando Frutos-Vivar, Gemma Rialp, Cesar Laborda, Laura Colinas, Rafael Cuena, and Rafael Fernández. 2016. “Effect of Postextubation High-flow Nasal Cannula Vs Conventional Oxygen Therapy on Reintubation in Low-risk Patients”. Jama. American Medical Association (AMA). doi:10.1001/jama.2016.2711.
- Butt, Sophia, Laura Pistidda, Leda Floris, Corrado Liperi, Francesco Vasques, Guy Glover, Nicholas A. Barrett, et al.. 2021. “Initial Setting of High-flow Nasal Oxygen Post Extubation Based on Mean Inspiratory Flow During a Spontaneous Breathing Trial”. Journal of Critical Care. Elsevier BV. doi:10.1016/j.jcrc.2020.12.022.
- Frat, Jean-Pierre, Arnaud W. Thille, Alain Mercat, Christophe Girault, Stéphanie Ragot, Sébastien Perbet, Gwénael Prat, et al.. 2015. “High-flow Oxygen Through Nasal Cannula in Acute Hypoxemic Respiratory Failure”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1503326.
- Mauri, Tommaso, Elena Spinelli, Francesca Dalla Corte, Eleonora Scotti, Cecilia Turrini, Marta Lazzeri, Laura Alban, et al.. 2019. “Noninvasive Assessment of Airflows by Electrical Impedance Tomography in Intubated Hypoxemic Patients: An Exploratory Study”. Annals of Intensive Care. Springer Science and Business Media LLC. doi:10.1186/s13613-019-0560-5.
- Li, Jie, J. Brady Scott, James B. Fink, Brooke Reed, Oriol Roca, and Rajiv Dhand. 2021. “Optimizing High-flow Nasal Cannula Flow Settings in Adult Hypoxemic Patients Based on Peak Inspiratory Flow During Tidal Breathing”. Annals of Intensive Care. Springer Science and Business Media LLC. doi:10.1186/s13613-021-00949-8.
- Hernández, Gonzalo, Concepción Vaquero, Laura Colinas, Rafael Cuena, Paloma González, Alfonso Canabal, Susana Sanchez, Maria Luisa Rodriguez, Ana Villasclaras, and Rafael Fernández. 2016. “Effect of Postextubation High-flow Nasal Cannula Vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in High-risk Patients”. Jama. American Medical Association (AMA). doi:10.1001/jama.2016.14194.
- Li J, Jing G, Scott JB. Year in Review 2019: High-Flow Nasal Cannula Oxygen Therapy for Adult Subjects. Respir Care. 2020 Apr;65(4):545-557. doi: 10.4187/respcare.07663.
- 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 High-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Oct 18;316(15):1565-1574. doi: 10.1001/jama.2016.14194. Erratum In: JAMA. 2016 Nov 15;316(19):2047-2048. JAMA. 2017 Feb 28;317(8):858.
- Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.
- 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 Trial. JAMA. 2016 Apr 5;315(13):1354-61. doi: 10.1001/jama.2016.2711.
- 2022. "Correlation of Peak Tidal Inspiratory Flow Measured Before and After Extubation in Adult Patients With Hypoxemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04971148.
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