Asymmetrical Versus Conventional High-flow Nasal Cannula in Acute Respiratory Failure

Acute Hypoxemic Respiratory Failure Clinical Trial

Official title:

The Physiologic Effects of Asymmetrical Versus Conventional High-flow Nasal Cannula in Acute Respiratory Failure. A Randomized Crossover Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06204276
• Other study ID #: 763/2566(IRB4)
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2024
• Est. completion date: May 15, 2025

Study information

• Verified date: January 2024
• Source: Siriraj Hospital
• Contact: Nuttapol Rittayamai, M.D.
• Phone: +664197757
• Email: nuttapol.rit[@]mahidol.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this randomized crossover physiological study is to evaluate the physiologic effects of asymmetrical nasal cannula and conventional nasal cannula in patients with acute respiratory failure. The main questions it aims to answer are: - 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.

Description:

High-flow nasal cannula (HFNC) is increasingly used in patients with acute respiratory failure. The physiologic benefits of HFNC can be explained via several mechanisms. These mechanisms lead to improve alveolar ventilation and decrease patient's inspiratory effort directly or indirectly. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 15, 2025
• Est. primary completion date: January 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Patients with acute hypoxemia respiratory failure

Inclusion Criteria:

• Age > 18 years old
• 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

Exclusion Criteria:

• Respiratory acidosis: pH < 7.30 and PaCO2 > 45 mmHg
• Hemodynamic instability requiring vasopressor initiation
• Diminished level of consciousness or uncooperative
• Active hemoptysis or pneumothorax requiring a chest tube
• Chronic severe neuromuscular disease
• Pregnancy Patients with acute hypercapnic COPD Inclusion criteria
• 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

• 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

Related Conditions & MeSH terms

• Acute Hypercapnic Respiratory Failure
• Acute Hypoxemic Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• 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

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital	Bangkok Noi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Siriraj Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (16)

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. — View Citation

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. — View Citation

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. Erratum In: Intensive Care Med. 2015 Apr;41(4):734. Sebastien-Bolz, Steffen [corrected to Bolz, Steffen-Sebastien]. — View Citation

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. — View Citation

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. — 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

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. — View Citation

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. — View Citation

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. — 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 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diaphragm thickening fraction	Diaphragm thickening fraction measured by ultrasound	15 minutes
Secondary	Parasternal intercostal thickening fraction	Parasternal intercostal thickening fraction measured by ultrasound	15 minutes
Secondary	Parasternal intercostal/diaphragm thickening fraction ratio	Contribution between parasternal intercostal and diaphragm thickening fraction	15 minutes
Secondary	Respiratory rate	Respiratory rate	15 minutes
Secondary	Oxygen saturation	Pulse oximetry	15 minutes
Secondary	Transcutaneous carbon dioxide (CO2) pressure	Transcutaneous CO2 monitor	15 minutes
Secondary	Mean arterial pressure	Blood pressure	15 minutes
Secondary	Heart rate	Heart rate	15 minutes