Asymmetrical Versus Conventional High-flow Nasal Cannula in Acute Respiratory Failure
NCT ID: NCT06204276
Last Updated: 2024-01-25
Study Results
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Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2024-01-20
2025-05-15
Brief Summary
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* Does the asymmetrical high-flow nasal cannula reduce the diaphragm and parasternal intercostal work activity of breathing measured by ultrasound compared to conventional high-flow nasal cannula?
* What is the effect of the asymmetrical high-flow nasal cannula on breathing pattern, gas exchange, and hemodynamic variables compared to conventional high-flow nasal cannula? Participants will received asymmetrical high-flow nasal cannula or conventional high-flow nasal cannula at a flow rate of 40 and 60 L/min in a random order.
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Detailed Description
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Recent clinical practice guidelines recommended to use HFNC in patients with acute hypoxemic respiratory failure over conventional oxygen therapy (COT) and noninvasive ventilation (NIV). A landmark clinical study demonstrated that patients with acute hypoxemic respiratory failure who received HFNC had better survival than COT and NIV. A systematic review and meta-analysis also demonstrated that HFNC significantly reduced escalation of respiratory support in patients with acute hypoxemic respiratory failure.
HFNC can also be an alternative respiratory support in patients with acute on chronic hypercapnic chronic obstructive pulmonary disease (COPD). Several physiological and clinical studies in COPD patients with exacerbations have also suggested that HFNC was not inferior to noninvasive ventilation (NIV) in COPD patients with mild to moderate exacerbation, in terms of gas exchange, treatment failure, intubation rate, and mortality rate. It may be also be used during NIV interruptions or after extubation.
Recently, an asymmetrical HFNC interface has been developed with a feature of one prong of smaller diameter and the other prong of larger diameter resulting in an increase in the overall cross-sectional area compared to conventional HFNC interface. An experimental study has shown that asymmetrical nasal cannula potentially increased positive end-expiratory pressure (PEEP) and enhanced carbon dioxide washout compared to conventional nasal cannula. Different respective effects in terms of pressure, resistance, and dead space washout between the two types of cannulas may explain different results, according to the population.
The aim of this study is to evaluate the physiologic effects of asymmetrical nasal cannula and conventional nasal cannula on diaphragm and parasternal intercostal activity of breathing measured by ultrasound in patients with acute respiratory failure.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Asymmetrical high-flow nasal cannula
* Asymmetrical nasal cannula (Optiflow+ Duet nasal cannula)
* Airvo-2 (Fisher\&Paykel)
Experimental: Asymmetrical high-flow nasal cannula
Asymmetrical high-flow nasal cannula will be set at 40 and 60 L/min in a random order. Temperature will be set at 37 degree celsius and inspired oxygen fraction (FiO2) will be adjusted to maintain oxygen saturation by pulse oximetry (SpO2) \>/= 94% in acute hypoxemic patients and between 92-94% in acute hypercapnic COPD patients
Conventional high-flow nasal cannula
* Conventional nasal cannula (Optiflow+ nasal cannula)
* Airvo-2 (Fisher\&Paykel)
Active comparator: Conventional high-flow nasal cannula
Conventional high-flow nasal cannula will be set at 40 and 60 L/min in a random order. Temperature will be set at 37 degree celsius and FiO2 will be adjusted to maintain SpO2 \>/= 94% in acute hypoxemic patients and between 92-94% in acute hypercapnic COPD patients
Interventions
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Experimental: Asymmetrical high-flow nasal cannula
Asymmetrical high-flow nasal cannula will be set at 40 and 60 L/min in a random order. Temperature will be set at 37 degree celsius and inspired oxygen fraction (FiO2) will be adjusted to maintain oxygen saturation by pulse oximetry (SpO2) \>/= 94% in acute hypoxemic patients and between 92-94% in acute hypercapnic COPD patients
Active comparator: Conventional high-flow nasal cannula
Conventional high-flow nasal cannula will be set at 40 and 60 L/min in a random order. Temperature will be set at 37 degree celsius and FiO2 will be adjusted to maintain SpO2 \>/= 94% in acute hypoxemic patients and between 92-94% in acute hypercapnic COPD patients
Eligibility Criteria
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Inclusion Criteria
* Acute respiratory failure within 7 days of hospital admission?
* Hypoxemia defined by arterial partial pressure of oxygen (PaO2)/FiO2 \< 300 mmHg or SpO2/FiO2 \< 315
* Already supported with HFNC device
* Age \> 40 years old
* Diagnosed COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guideline (postbronchodilator forced expiratory volume at 1 second (FEV1)/forced vital capacity (FVC) \< 70%)
* Exacerbation requiring hospitalization; at least 2 of the following criteria
1. Respiratory rate \> 24/min
2. Use of respiratory accessory muscles or paradoxical motion of the abdomen
3. Acute respiratory acidosis with arterial or venous pH \< 7.35 and/or PaCO2 \> 45 mmHg
Exclusion Criteria
* Hemodynamic instability requiring vasopressor initiation
* Diminished level of consciousness or uncooperative
* Active hemoptysis or pneumothorax requiring a chest tube
* Chronic severe neuromuscular disease
* Pregnancy
* pH \< 7.25
* Hemodynamic instability requiring vasopressor initiation
* Persistent hypoxemia despite supplemental oxygen therapy
* Diminished level of consciousness or uncooperative
* Active hemoptysis or pneumothorax requiring a chest tube
* Associated severe chronic neuromuscular disease
* Pregnancy
18 Years
90 Years
ALL
No
Sponsors
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Siriraj Hospital
OTHER
Responsible Party
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Nuttapol Rittayamai
Associate Professor
Principal Investigators
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Nuttapol Rittayamai, M.D.
Role: PRINCIPAL_INVESTIGATOR
Siriraj Hospital
Locations
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Faculty of Medicine Siriraj Hospital
Bangkok Noi, Bangkok, Thailand
Countries
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Central Contacts
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Facility Contacts
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References
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Ricard JD, Roca O, Lemiale V, Corley A, Braunlich J, Jones P, Kang BJ, Lellouche F, Nava S, Rittayamai N, Spoletini G, Jaber S, Hernandez G. Use of nasal high flow oxygen during acute respiratory failure. Intensive Care Med. 2020 Dec;46(12):2238-2247. doi: 10.1007/s00134-020-06228-7. Epub 2020 Sep 8.
Biselli P, Fricke K, Grote L, Braun AT, Kirkness J, Smith P, Schwartz A, Schneider H. Reductions in dead space ventilation with nasal high flow depend on physiological dead space volume: metabolic hood measurements during sleep in patients with COPD and controls. Eur Respir J. 2018 May 30;51(5):1702251. doi: 10.1183/13993003.02251-2017. Print 2018 May.
Vieira F, Bezerra FS, Coudroy R, Schreiber A, Telias I, Dubo S, Cavalot G, Pereira SM, Piraino T, Brochard LJ. High Flow Nasal Cannula compared to Continuous Positive Airway Pressure: a bench and physiological study. J Appl Physiol (1985). 2022 May 5. doi: 10.1152/japplphysiol.00416.2021. Online ahead of print.
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.
Rittayamai N, Phuangchoei P, Tscheikuna J, Praphruetkit N, Brochard L. Effects of high-flow nasal cannula and non-invasive ventilation on inspiratory effort in hypercapnic patients with chronic obstructive pulmonary disease: a preliminary study. Ann Intensive Care. 2019 Oct 22;9(1):122. doi: 10.1186/s13613-019-0597-5.
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 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.
Nagata K, Horie T, Chohnabayashi N, Jinta T, Tsugitomi R, Shiraki A, Tokioka F, Kadowaki T, Watanabe A, Fukui M, Kitajima T, Sato S, Tsuda T, Kishimoto N, Kita H, Mori Y, Nakayama M, Takahashi K, Tsuboi T, Yoshida M, Hataji O, Fuke S, Kagajo M, Nishine H, Kobayashi H, Nakamura H, Okuda M, Tachibana S, Takata S, Osoreda H, Minami K, Nishimura T, Ishida T, Terada J, Takeuchi N, Kohashi Y, Inoue H, Nakagawa Y, Kikuchi T, Tomii K. Home High-Flow Nasal Cannula Oxygen Therapy for Stable Hypercapnic COPD: A Randomized Clinical Trial. Am J Respir Crit Care Med. 2022 Dec 1;206(11):1326-1335. doi: 10.1164/rccm.202201-0199OC.
Cortegiani A, Longhini F, Madotto F, Groff P, Scala R, Crimi C, Carlucci A, Bruni A, Garofalo E, Raineri SM, Tonelli R, Comellini V, Lupia E, Vetrugno L, Clini E, Giarratano A, Nava S, Navalesi P, Gregoretti C; H. F.-AECOPD study investigators. High flow nasal therapy versus noninvasive ventilation as initial ventilatory strategy in COPD exacerbation: a multicenter non-inferiority randomized trial. Crit Care. 2020 Dec 14;24(1):692. doi: 10.1186/s13054-020-03409-0.
Lee MK, Choi J, Park B, Kim B, Lee SJ, Kim SH, Yong SJ, Choi EH, Lee WY. High flow nasal cannulae oxygen therapy in acute-moderate hypercapnic respiratory failure. Clin Respir J. 2018 Jun;12(6):2046-2056. doi: 10.1111/crj.12772. Epub 2018 Mar 5.
Longhini F, Pisani L, Lungu R, Comellini V, Bruni A, Garofalo E, Laura Vega M, Cammarota G, Nava S, Navalesi P. High-Flow Oxygen Therapy After Noninvasive Ventilation Interruption in Patients Recovering From Hypercapnic Acute Respiratory Failure: A Physiological Crossover Trial. Crit Care Med. 2019 Jun;47(6):e506-e511. doi: 10.1097/CCM.0000000000003740.
Tan D, Walline JH, Ling B, Xu Y, Sun J, Wang B, Shan X, Wang Y, Cao P, Zhu Q, Geng P, Xu J. High-flow nasal cannula oxygen therapy versus non-invasive ventilation for chronic obstructive pulmonary disease patients after extubation: a multicenter, randomized controlled trial. Crit Care. 2020 Aug 6;24(1):489. doi: 10.1186/s13054-020-03214-9.
Tatkov S, Rees M, Gulley A, van den Heuij LGT, Nilius G. Asymmetrical nasal high flow ventilation improves clearance of CO2 from the anatomical dead space and increases positive airway pressure. J Appl Physiol (1985). 2023 Feb 1;134(2):365-377. doi: 10.1152/japplphysiol.00692.2022. Epub 2023 Jan 12.
Slobod D, Spinelli E, Crotti S, Lissoni A, Galazzi A, Grasselli G, Mauri T. Effects of an asymmetrical high flow nasal cannula interface in hypoxemic patients. Crit Care. 2023 Apr 18;27(1):145. doi: 10.1186/s13054-023-04441-6.
Goligher EC, Laghi F, Detsky ME, Farias P, Murray A, Brace D, Brochard LJ, Bolz SS, Rubenfeld GD, Kavanagh BP, Ferguson ND. Measuring diaphragm thickness with ultrasound in mechanically ventilated patients: feasibility, reproducibility and validity. Intensive Care Med. 2015 Apr;41(4):642-9. doi: 10.1007/s00134-015-3687-3. Epub 2015 Feb 19.
Zambon M, Greco M, Bocchino S, Cabrini L, Beccaria PF, Zangrillo A. Assessment of diaphragmatic dysfunction in the critically ill patient with ultrasound: a systematic review. Intensive Care Med. 2017 Jan;43(1):29-38. doi: 10.1007/s00134-016-4524-z. Epub 2016 Sep 12.
Vivier E, Mekontso Dessap A, Dimassi S, Vargas F, Lyazidi A, Thille AW, Brochard L. Diaphragm ultrasonography to estimate the work of breathing during non-invasive ventilation. Intensive Care Med. 2012 May;38(5):796-803. doi: 10.1007/s00134-012-2547-7. Epub 2012 Apr 5.
Other Identifiers
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763/2566(IRB4)
Identifier Type: -
Identifier Source: org_study_id
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