Flow Rates of High-flow Nasal Cannula and Extubation Outcome

NCT04934163 | Completed

• 1 other identifier: 202103054RINB
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypoxemic Respiratory Failure

Keywords

high-flow nasal cannula; hypoxemic respiratory failure; oxygen therapy; postextubation respiratory failure

Outcome Measures

Primary Outcomes (1)

• 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

  48 hours after extubation

Secondary Outcomes (10)

• ICU mortality

  ICU stay

• In-hospital mortality

  Hospital stay

• 28-day mortality

  28 days

• Time to successful liberation from mechanical ventilation

  28 days

• AUC(area under curve) of respiratory rate (0-24 hours)

  24 hours

Study Arms (2)

60 L/min arm

EXPERIMENTAL

The flow rate of HFNC(high-flow nasal cannula) is set as 60 L/min after extubation.

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.

Other: Flow rate setting of high-flow nasal cannula (initially 40L/min)

Interventions

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%.

60 L/min arm

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%.

40 L/min arm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• \< 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)

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Related Publications (16)

• 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.

  PMID: 28170290 RESULT

• Saiphoklang 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.

  PMID: 30286153 RESULT

• 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 RESULT

• Rochwerg 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.

  PMID: 30888444 RESULT

• 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 RESULT

• Mauri 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.

  PMID: 28762180 RESULT

• Mauri 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.

  PMID: 29743098 RESULT

• Maggiore 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.

  PMID: 25003980 RESULT

• Rittayamai 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.

  PMID: 24046462 RESULT

• 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.

  PMID: 26975498 RESULT

• 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.

  PMID: 27706464 RESULT

• Fernandez 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.

  PMID: 28466461 RESULT

• Song 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.

  PMID: 29069260 RESULT

• Theerawit 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.

  PMID: 33012589 RESULT

• Jing 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.

  PMID: 30887549 RESULT

• Ruan SY, Kuo YW, Huang CT, Chien YC, Huang CK, Kuo LC, Kuo JS, Chung KP, Ku SC, Chien JY; Taiwan Collaborative Intensive Care Study (TACTICS) Group. Effect of Flow Rates of High-Flow Nasal Cannula on Extubation Outcomes: A Randomized Controlled Trial. Chest. 2025 May;167(5):1388-1396. doi: 10.1016/j.chest.2024.12.021. Epub 2024 Dec 30.

  PMID: 39742913 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Daniel Fu-Chang Tsai, MD, PhD

  Research Ethics Committee of the National Taiwan University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 22, 2021
• Study Start: September 1, 2021
• Primary Completion: March 28, 2023
• Study Completion: April 30, 2023
• Last Updated: May 10, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)