Skip to main content
SpringerLink
Log in

Étude FLORALI (High-FLow Oxygen Therapy for the Resuscitation of Acute Lung Injury): intérêt de l’oxygénothérapie nasale humidifiée et réchauffée à haut débit dans l’insuffisance respiratoire aiguë non hypercapnique de l’adulte. Présentation d’un essai multicentrique, randomisé, contrôlé en ouvert

FLORALI study (High-Flow Oxygen Therapy for the Resuscitation of Acute Lung Injury): use of nasal high-flow oxygen therapy in non-hypercapnic acute respiratory failure. Introduction to the study protocol

  • Article Original / Original Article
  • Published:
Réanimation

Résumé

L’intérêt de la ventilation non invasive (VNI) dans la prise en charge de la pneumopathie hypoxémiante du sujet immunocompétent est controversé, avec un taux d’échec aboutissant à une intubation trachéale dans environ 60 % des cas. L’oxygénothérapie à haut débit nasale avec humidification (O2-HDN) est une nouvelle technique assurant une FiO2 élevée et une pression expiratoire positive. L’étude FLORALI a pour but d’évaluer l’utilisation de l’O2-HDN dans l’insuffisance respiratoire aiguë (IRA) hypoxémique, seule, associée à la VNI ou comparativement à l’oxygénothérapie conventionnelle. Patients et méthode: Cette étude multicentrique, randomisée, ouverte, contrôlée a pour but de comparer trois stratégies d’oxygénation dans la prise en charge précoce et non invasive de l’IRA hypoxémique non hypercapnique: l’association VNI/O2-HDN, l’O2-HDN seule et l’O2 seule. Les patients sont inclus si les critères suivants sont réunis: dyspnée de repos sévère avec mise en jeu des muscles respiratoires accessoires, fréquence respiratoire supérieure ou égale à 25 cycles par minute, PaO2/FiO2 inférieur ou égal à 300 mmHg sous O2 au masque à haute concentration et PaCO2 inférieure ou égale à 45 mmHg. L’objectif principal est de montrer une réduction significative du taux d’intubation dans les groupes traités selon une stratégie comprenant l’O2-HDN. Ainsi, 300 patients sont nécessaires pour mettre en évidence une différence absolue de 20 % entre les deux groupes. On estime, en effet, à 60 % le recours à la ventilation invasive dans le groupe O2 et l’on souhaite montrer qu’elle n’est que de 40 % dans les groupes O2-HDN et VNI/O2-HDN. Cette étude bénéficie du soutien du Réseau européen de recherche en ventilation artificielle (REVA).

Abstract

The use of non-invasive ventilation (NIV) in nonimmunosuppressed patients with acute hypoxemic nonhypercapnic respiratory failure is controversial. About 60% of the patients treated with NIV require intubation with a high mortality rate. Nasal high-flow oxygen therapy (NHFO) is a recent device with possible beneficial effects as delivering high FiO2 and improving comfort between NIV sessions. The FLORALI study aims to evaluate the use of NHFO in non-immunosuppressed patients with acute hypoxemic non-hypercapnic respiratory failure. Patients and methods: we are conducting a randomized multicentric study comparing three strategies of ventilation support in patients admitted to the intensive care unit (ICU) for acute hypoxemic respiratory failure: 1) standard oxygen therapy, 2) NHFO, and 3) NHFO associated with NIV for at least 8 h per day during three days. All patients admitted to the ICU for acute respiratory failure can be included if presenting respiratory rate ≥ 25 breaths per minute, hypoxemia defined by PaO2/FiO2 ratio ≤ 300 mmHg using at least 10 l/min oxygen, FiO2 being measured using an oxygen analyzer located in the mask, and PaCO2 ≤ 45 mmHg. The main objective is to compare rates of intubation with each of the three tested strategies. A sample of 300 patients (100 patients in each group) is required to detect a 20% reduction in the intubation rate, considering an intubation rate of 60% in the standard group and of 40% in the groups using NHFO. This study is supported by the REVA group.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Références

  1. Combes A, Costa MA, Trouillet JL, et al (2003) Morbidity, mortality, and quality-of-life outcomes of patients requiring ≥ 14 days of mechanical ventilation. Crit Care Med. 31:1373–1381

    Article  PubMed  Google Scholar 

  2. Moine P, Vercken JB, Chevret S, et al (1994) Severe community-acquired pneumonia. Etiology, epidemiology, and prognosis factors. French Study Group for Community-Acquired Pneumonia in the Intensive Care Unit. Chest 105:1487–1495

    Article  PubMed  CAS  Google Scholar 

  3. Carlucci A, Richard JC, Wysocki M, SRLF Collaborative Group on Mechanical Ventilation (2001) Non-invasive versus conventional mechanical ventilation. An epidemiologic survey. Am J Respir Crit Care Med 163:874–880

    Article  PubMed  CAS  Google Scholar 

  4. Masip J, Betbesé AJ, Páez J, et al (2000) Non-invasive pressure support ventilation versus conventional oxygen therapy in acute cardiogenic pulmonary oedema: a randomised trial. Lancet 356:2126–2132

    Article  PubMed  CAS  Google Scholar 

  5. Antonelli M, Conti G, Bufi M, et al (2000) Non-invasive ventilation for treatment of acute respiratory failure in patients undergoing solid organ transplantation: a randomized trial. JAMA 283:235–241

    Article  PubMed  CAS  Google Scholar 

  6. Hilbert G, Gruson D, Vargas F, et al (2001) Non-invasive ventilation in immunosuppressed patients with pulmonary infiltrates, fever, and acute respiratory failure. N Engl J Med. 344:481–487

    Article  PubMed  CAS  Google Scholar 

  7. Auriant I, Jallot A, Hervé P, et al (2001) Non-invasive ventilation reduces mortality in acute respiratory failure following lung resection. Am J Respir Crit Care Med 164:1231–1235

    Article  PubMed  CAS  Google Scholar 

  8. Guérin C, Girard R, Chemorin C, et al (1997) Facial mask noninvasive mechanical ventilation reduces the incidence of nosocomial pneumonia. A prospective epidemiological survey from a single ICU. Intensive Care Med 23:1024–1032. Erratum (1998) in Intensive Care Med 24:27

    Article  PubMed  Google Scholar 

  9. Wysocki M, Tric L, Wolff MA, et al (1995) Non-invasive pressure support ventilation in patients with acute respiratory failure. A randomized comparison with conventional therapy. Chest 107:761–768

    Article  PubMed  CAS  Google Scholar 

  10. Antonelli M, Conti G, Rocco M, et al (1998) A comparison of non-invasive positive-pressure ventilation and conventional mechanical ventilation in patients with acute respiratory failure. N Engl J Med 339:429–435

    Article  PubMed  CAS  Google Scholar 

  11. Antonelli M, Conti G, Moro ML, et al (2001) Predictors of failure of non-invasive positive pressure ventilation in patients with acute hypoxemic respiratory failure: a multi-center study. Intensive Care Med 27:1718–1728

    Article  PubMed  CAS  Google Scholar 

  12. Confalonieri M, Potena A, Carbone G, et al (1999) Acute respiratory failure in patients with severe community-acquired pneumonia. A prospective randomized evaluation of non-invasive ventilation. Am J Respir Crit Care Med 160:1585–1591

    Article  PubMed  CAS  Google Scholar 

  13. Ferrer M, Esquinas A, Leon M, et al (2003) Non-invasive ventilation in severe hypoxemic respiratory failure: a randomized clinical trial. Am J Respir Crit Care Med 168:1438–1444

    Article  PubMed  Google Scholar 

  14. Honrubia T, García López FJ, et al (2005) Non-invasive versus conventional mechanical ventilation in acute respiratory failure: a multicenter, randomized controlled trial. Chest 128:3916–3924

    Article  PubMed  Google Scholar 

  15. Consensus SRLF Ventilation non invasive au cours de l’insuffisance respiratoire aiguë (nouveau-né exclu) 2006

  16. Demoule A, Girou E, Richard JC, et al (2006) Benefits and risks of success or failure of non-invasive ventilation. Intensive Care Med 32:1756–1765

    Article  PubMed  Google Scholar 

  17. Jolliet P, Abajo B, Pasquina P, et al (2001) Non-invasive pressure support ventilation in severe community-acquired pneumonia. Intensive Care Med 27:812–821

    Article  PubMed  CAS  Google Scholar 

  18. Domenighetti G, Gayer R, Gentilini R (2002). Non-invasive pressure support ventilation in non-COPD patients with acute cardiogenic pulmonary edema and severe community-acquired pneumonia: acute effects and outcome. Intensive Care Med 28:1226–1232

    Article  PubMed  CAS  Google Scholar 

  19. Martin TJ, Hovis JD, Costantino JP, et al (2000) A randomized, prospective evaluation of non-invasive ventilation for acute respiratory failure. Am J Respir Crit Care Med 161:807–813

    Article  PubMed  CAS  Google Scholar 

  20. Antonelli M, Conti G, Esquinas A, et al (2007) A multiple-center survey on the use in clinical practice of non-invasive ventilation as a first-line intervention for acute respiratory distress syndrome. Crit Care Med 35:18–25

    Article  PubMed  Google Scholar 

  21. Phua J, Kong K, Lee KH, et al (2005) Non-invasive ventilation in hypercapnic acute respiratory failure due to chronic obstructive pulmonary disease versus other conditions: effectiveness and predictors of failure. Intensive Care Med 31:533–539

    Article  PubMed  Google Scholar 

  22. Adda M, Coquet I, Darmon M, et al (2008) Predictors of noninvasive ventilation failure in patients with hematologic malignancy and acute respiratory failure. Crit Care Med 36:2766–2772

    Article  PubMed  Google Scholar 

  23. Kallet RH, Hemphill JC 3rd, Dicker RA, et al (2007) The spontaneous breathing pattern and work of breathing of patients with acute respiratory distress syndrome and acute lung injury. Respir Care 52:989–995

    PubMed  Google Scholar 

  24. Gibson RL, Comer PB, Beckham RW, et al (1976) Actual tracheal oxygen concentrations with commonly used oxygen equipment. Anesthesiology 44:71–73

    Article  PubMed  CAS  Google Scholar 

  25. Williams AB, Ritchie JE, Gerard C (2006) Evaluation of high flow nasal oxygenation system: gas analysis and pharyngeal pressure. Intensive Care Medicine 32 (Suppl 1):S219.

    Google Scholar 

  26. Parke R, McGuinness S, Eccleston M (2009) Nasal high-flow therapy delivers low level positive airway pressure. Br J Anaesth 103:886–890

    Article  PubMed  CAS  Google Scholar 

  27. Groves N, Tobin A (2007) High flow nasal oxygen generates positive airway pressure in adult volunteers. Aust Crit Care 20:126–131

    Article  PubMed  Google Scholar 

  28. Aitken RC (1969) Measurement of feeling using visual analogue scales. Roc Soc Med 62: 989–993

    CAS  Google Scholar 

  29. Vitacca M, Bianchi L, Zanotti E, et al (2004) Assessment of physiologic variables and subjective comfort under different levels of pressure support ventilation. Chest 126:851–859

    Article  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Service de réanimation médicale, CHRU Jean-Bernard, rue de la Milétrie, BP 577, F-86021, Poitiers cedex, France

    J. -P. Frat & A. Thille

  2. Service de réanimation médicale, CHRU de Rouen, UPRES EA 3830-IFRMP.23, F-76000, Rouen, France

    C. Girault

  3. CIC-P 802, CHRU Jean-Bernard, rue de la Milétrie, BP 577, F-86021, Poitiers cedex, France

    S. Ragot

Authors
  1. J. -P. Frat
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. A. Thille
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. C. Girault
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. S. Ragot
    View author publications

    You can also search for this author in PubMed Google Scholar

Consortia

REVA: Réseau européen de recherche en ventilation artificielle

Corresponding author

Correspondence to J. -P. Frat.

Additional information

Comité scientifique

Dr Jean-Pierre Frat: service de réanimation médicale et de médecine interne, CHU de Poitiers

Dr Christophe Giraud: service de réanimation médicale, CHRU de Rouen

Réseau REVA: Pr Laurent Brochard, Pr Alain Mercat, Pr Jean-Christophe Richard, Dr Arnaud Thille

Liste des investigateurs principaux de l’étude FLORALI: Pr Argaud Laurent (CHU de Lyon E.-Herriot), Dr Beuret Pascal (CH de Roanne), Dr Boulain Thierry (CHR d’Orléans), Dr Collet François (CH de Saint-Malo), Dr Conrad Marie (CHU de Nancy), Pr Constantin Jean-Michel (CHU de Clermont-Ferrand), Dr Danin Pierre-Eric (CHU de Lyon-Sud), Dr Devaquet Jérôme (hôpital Foch), Pr Duguet Alexandre (CHU La Pitié-Salpêtrière), Dr Fartoukh Muriel (CHU Tenon), Dr Frat Jean-Pierre (CHU de Poitiers), Dr Girault Christophe (CHU de Rouen), Pr Guerin Claude (CHU de Lyon La Croix-Rousse), Pr Klouche Kada (CHU de Montpellier), Dr Lesieur Olivier (CH de La Rochelle), Dr Mariot Jacques (hôpital de Metz), Dr Marque Sophie (CHU de Rennes), Pr Mercat Alain (CHU d’Angers), Pr Mira Jean-Paul (hôpital Cochin), Dr Saad Nseir (CHU de Lille), Dr Prat Gwénaël (CHU de Brest), Dr Quenot J.P. (CHU de Dijon), Pr Rabbat Antoine (hôpital Hôtel-Dieu, Paris), Dr Reignier Jean (CHD La Roche/Yon), Pr Ricard Jean-Damien (CHU de Colombes), Dr Rigaud Jean-Philippe (CHG de Dieppe), Jean Roseler (UCL Bruxelles), Dr Thille Arnaud/Dr Razazi Keyvan (CHU Mondor), Pr Vargas Fréderic (CHU de Bordeaux).

Rights and permissions

Reprints and permissions

About this article

Cite this article

Frat, J.P., Thille, A., Girault, C. et al. Étude FLORALI (High-FLow Oxygen Therapy for the Resuscitation of Acute Lung Injury): intérêt de l’oxygénothérapie nasale humidifiée et réchauffée à haut débit dans l’insuffisance respiratoire aiguë non hypercapnique de l’adulte. Présentation d’un essai multicentrique, randomisé, contrôlé en ouvert. Réanimation 22, 90–99 (2013). https://doi.org/10.1007/s13546-012-0527-4

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s13546-012-0527-4

Mots clés

Keywords

Search

Navigation