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

NCT06204276 | Completed

• 1 other identifier: 763/2566(IRB4)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Hypoxemic Respiratory Failure; Acute Hypercapnic Respiratory Failure

Keywords

high-flow nasal cannula; respiratory failure; respiratory muscles; ultrasound

Outcome Measures

Primary Outcomes (1)

• Diaphragm thickening fraction

  Diaphragm thickening fraction measured by ultrasound

  15 minutes

Secondary Outcomes (7)

• Parasternal intercostal thickening fraction

  15 minutes

• Parasternal intercostal/diaphragm thickening fraction ratio

  15 minutes

• Respiratory rate

  15 minutes

• Oxygen saturation

  15 minutes

• Transcutaneous carbon dioxide (CO2) pressure

  15 minutes

Study Arms (2)

Asymmetrical high-flow nasal cannula

EXPERIMENTAL

* Asymmetrical nasal cannula (Optiflow+ Duet nasal cannula) * Airvo-2 (Fisher\&Paykel)

Device: Experimental: Asymmetrical high-flow nasal cannula

Conventional high-flow nasal cannula

ACTIVE COMPARATOR

* Conventional nasal cannula (Optiflow+ nasal cannula) * Airvo-2 (Fisher\&Paykel)

Device: Active comparator: Conventional high-flow nasal cannula

Interventions

Experimental: Asymmetrical high-flow nasal cannula DEVICE

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

Asymmetrical high-flow nasal cannula

Active comparator: Conventional high-flow nasal cannula DEVICE

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

Conventional high-flow nasal cannula

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Respiratory rate \> 24/min
• Use of respiratory accessory muscles or paradoxical motion of the abdomen
• Acute respiratory acidosis with arterial or venous pH \< 7.35 and/or PaCO2 \> 45 mmHg
• pH \< 7.25
• Hemodynamic instability requiring vasopressor initiation
• Persistent hypoxemia despite supplemental oxygen therapy

Sponsors & Collaborators

• Siriraj Hospital: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital

Bangkok Noi, Bangkok, 10700, Thailand

Location

Related Publications (16)

• 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.

  PMID: 32901374 BACKGROUND

• 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.

  PMID: 29724917 BACKGROUND

• 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.

  PMID: 35511720 BACKGROUND

• 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.

  PMID: 27997805 BACKGROUND

• 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.

  PMID: 31641959 BACKGROUND

• 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.

  PMID: 33201321 BACKGROUND

• 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.

  PMID: 35771533 BACKGROUND

• 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.

  PMID: 33317579 BACKGROUND

• 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.

  PMID: 29392846 BACKGROUND

• 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.

  PMID: 30882477 BACKGROUND

• 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.

  PMID: 32762701 BACKGROUND

• 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.

  PMID: 36633864 BACKGROUND

• 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.

  PMID: 37072854 BACKGROUND

• 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.

  PMID: 25693448 BACKGROUND

• 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.

  PMID: 27620292 BACKGROUND

• 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.

  PMID: 22476448 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Nuttapol Rittayamai, M.D.

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 12, 2024
• Study Start: January 20, 2024
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)