. 2019 Aug 10;9(8):e029798.

doi: 10.1136/bmjopen-2019-029798.

High-flow nasal oxygen therapy alone or with non-invasive ventilation in immunocompromised patients admitted to ICU for acute hypoxemic respiratory failure: the randomised multicentre controlled FLORALI-IM protocol

Rémi Coudroy¹, Jean-Pierre Frat², Stephan Ehrmann³, Frédéric Pène⁴, Nicolas Terzi⁵, Maxens Decavèle⁶, Gwenaël Prat⁷, Charlotte Garret⁸, Damien Contou⁹, Jeremy Bourenne¹⁰, Arnaud Gacouin¹¹, Christophe Girault¹², Jean Dellamonica¹³, Dominique Malacrino¹⁴, Guylaine Labro¹⁵, Jean-Pierre Quenot¹⁶, Alexandre Herbland¹⁷, Sébastien Jochmans¹⁸, Jérôme Devaquet¹⁹, Dalila Benzekri²⁰, Emmanuel Vivier²¹, Saad Nseir²², Gwenhaël Colin²³, Didier Thévenin²⁴, Giacomo Grasselli²⁵, Mona Assefi²⁶, Claude Guerin²⁷, David Bougon²⁸, Thierry Lherm²⁹, Achille Kouatchet³⁰, Stéphanie Ragot³¹, Arnaud W Thille²; REVA Network

Affiliations

¹ Médecine Intensive et Réanimation, INSERM CIC 1402, groupe ALIVE, Université de Poitiers, CHU de Poitiers, Poitiers, France r.coudroy@yahoo.fr.
² Médecine Intensive et Réanimation, INSERM CIC 1402, groupe ALIVE, Université de Poitiers, CHU de Poitiers, Poitiers, France.
³ Médecine Intensive et Réanimation, CIC 1415, CRICS-TriggerSEP research network, Centre d'étude des pathologies respiratoires, INSERM U1100, Université de Tours, CHRU de Tours, Tours, France.
⁴ Médecine Intensive et Réanimation, Université Paris Descartes, Hôpital Cochin, APHP, Paris, France.
⁵ Médecine Intensive et Réanimation, INSERM, Université Grenoble-Alpes, U1042, HP2, CHU Grenoble Alpes, Grenoble, France.
⁶ Service de Pneumologie, Médecine Intensive et Réanimation, Département R3S, AP-HP, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Sorbonne Université, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Paris, France.
⁷ Médecine Intensive et Réanimation, CHU de Brest, Brest, France.
⁸ Médecine Intensive et Réanimation, CHU de Nantes, Nantes, France.
⁹ Service de Réanimation Polyvalente, Centre Hospitalier Victor Dupouy, Argenteuil, France.
¹⁰ Médecine Intensive et Réanimation, Réanimation des Urgences, Aix-Marseille Université, CHU La Timone 2, Marseille, France.
¹¹ Service des Maladies Infectieuses et Réanimation Médicale, CHU de Rennes, Hôpital Ponchaillou, Rennes, France.
¹² Service de Réanimation Médicale, Normandie Univ, Unirouen, UPRES EA-3830, Hôpital Charles Nicolle, CHU de Rouen, Rouen, France.
¹³ Médecine Intensive Réanimation, CHU de Nice, Nice, France.
¹⁴ Service de Réanimation, Centre hospitalier de Béthune, Beuvry, France.
¹⁵ Medical Intensive Care Unit, Research Center EA3920, University of Franche-Comté, Hôpital Jean Minjoz, Besançon, France.
¹⁶ Service de Médecine Intensive-Réanimation, INSERM U1231, Equipe Lipness, Université Bourgogne-Franche-Comté, UMR1231 Lipides, Nutrition, Cancer, équipe Lipness, LipSTIC LabEx, Fondation de coopération scientifique Bourgogne-Franche-Comté, INSERM, CIC 1432, Module Epidémiologie Clinique, Centre d'Investigation Clinique, Module Epidémiologie Clinique/Essais Cliniques, CHU Dijon, Dijon, France.
¹⁷ Service de Réanimation, Centre hospitalier Saint Louis, La Rochelle, France.
¹⁸ Service de Réanimation, Centre hospitalier Sud-Ile-de France, Melun, France.
¹⁹ Medical-Surgical Intensive Care Unit, Hôpital Foch, Suresnes, France.
²⁰ Médecine Intensive et Réanimation, Groupe Hospitalier Régional d'Orléans, Orléans, France.
²¹ Reanimation Polyvalente, Hôpital Saint Joseph Saint Luc, Lyon, France.
²² Centre de Réanimation, Université de Lille, CHU de Lille, Lille, France.
²³ Service de Médecine Intensive et Réanimation, Centre Hospitalier Départemental de Vendée, La Roche-sur-Yon, France.
²⁴ Service de Réanimation Polyvalente, CH de Lens, Lens, France.
²⁵ Department of Anesthesiology, Intensive Care and Emergency, Department of Pathophysiology and Transplantation, University of Milan, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
²⁶ Multidisciplinary Intensive Care Unit, Department of Anesthesia and Critical Care Medicine, School of Medicine, University Pierre and Marie Curie (UPMC), Pitié-Salpétrière Hospital, APHP, Paris, France.
²⁷ Service de Médecine Intensive-Réanimation, Université de Lyon, INSERM 955, Créteil, Hôpital de La Croix-Rousse, Hospices civils de Lyon, Lyon, France.
²⁸ Service de Réanimation, Centre Hospitalier Annecy Genevois, Annecy, France.
²⁹ Medical ICU, Hospital of Chartres, Coudray, France.
³⁰ Medical ICU, CHU d'Angers, Angers, France.
³¹ INSERM CIC 1402, Biostatistics, Université de Poitiers, Poitiers, France.

PMID: 31401603
PMCID: PMC6701687
DOI: 10.1136/bmjopen-2019-029798

High-flow nasal oxygen therapy alone or with non-invasive ventilation in immunocompromised patients admitted to ICU for acute hypoxemic respiratory failure: the randomised multicentre controlled FLORALI-IM protocol

Rémi Coudroy et al. BMJ Open. 2019.

. 2019 Aug 10;9(8):e029798.

doi: 10.1136/bmjopen-2019-029798.

Authors

Affiliations

¹ Médecine Intensive et Réanimation, INSERM CIC 1402, groupe ALIVE, Université de Poitiers, CHU de Poitiers, Poitiers, France r.coudroy@yahoo.fr.
² Médecine Intensive et Réanimation, INSERM CIC 1402, groupe ALIVE, Université de Poitiers, CHU de Poitiers, Poitiers, France.
³ Médecine Intensive et Réanimation, CIC 1415, CRICS-TriggerSEP research network, Centre d'étude des pathologies respiratoires, INSERM U1100, Université de Tours, CHRU de Tours, Tours, France.
⁴ Médecine Intensive et Réanimation, Université Paris Descartes, Hôpital Cochin, APHP, Paris, France.
⁵ Médecine Intensive et Réanimation, INSERM, Université Grenoble-Alpes, U1042, HP2, CHU Grenoble Alpes, Grenoble, France.
⁶ Service de Pneumologie, Médecine Intensive et Réanimation, Département R3S, AP-HP, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Sorbonne Université, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Paris, France.
⁷ Médecine Intensive et Réanimation, CHU de Brest, Brest, France.
⁸ Médecine Intensive et Réanimation, CHU de Nantes, Nantes, France.
⁹ Service de Réanimation Polyvalente, Centre Hospitalier Victor Dupouy, Argenteuil, France.
¹⁰ Médecine Intensive et Réanimation, Réanimation des Urgences, Aix-Marseille Université, CHU La Timone 2, Marseille, France.
¹¹ Service des Maladies Infectieuses et Réanimation Médicale, CHU de Rennes, Hôpital Ponchaillou, Rennes, France.
¹² Service de Réanimation Médicale, Normandie Univ, Unirouen, UPRES EA-3830, Hôpital Charles Nicolle, CHU de Rouen, Rouen, France.
¹³ Médecine Intensive Réanimation, CHU de Nice, Nice, France.
¹⁴ Service de Réanimation, Centre hospitalier de Béthune, Beuvry, France.
¹⁵ Medical Intensive Care Unit, Research Center EA3920, University of Franche-Comté, Hôpital Jean Minjoz, Besançon, France.
¹⁶ Service de Médecine Intensive-Réanimation, INSERM U1231, Equipe Lipness, Université Bourgogne-Franche-Comté, UMR1231 Lipides, Nutrition, Cancer, équipe Lipness, LipSTIC LabEx, Fondation de coopération scientifique Bourgogne-Franche-Comté, INSERM, CIC 1432, Module Epidémiologie Clinique, Centre d'Investigation Clinique, Module Epidémiologie Clinique/Essais Cliniques, CHU Dijon, Dijon, France.
¹⁷ Service de Réanimation, Centre hospitalier Saint Louis, La Rochelle, France.
¹⁸ Service de Réanimation, Centre hospitalier Sud-Ile-de France, Melun, France.
¹⁹ Medical-Surgical Intensive Care Unit, Hôpital Foch, Suresnes, France.
²⁰ Médecine Intensive et Réanimation, Groupe Hospitalier Régional d'Orléans, Orléans, France.
²¹ Reanimation Polyvalente, Hôpital Saint Joseph Saint Luc, Lyon, France.
²² Centre de Réanimation, Université de Lille, CHU de Lille, Lille, France.
²³ Service de Médecine Intensive et Réanimation, Centre Hospitalier Départemental de Vendée, La Roche-sur-Yon, France.
²⁴ Service de Réanimation Polyvalente, CH de Lens, Lens, France.
²⁵ Department of Anesthesiology, Intensive Care and Emergency, Department of Pathophysiology and Transplantation, University of Milan, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
²⁶ Multidisciplinary Intensive Care Unit, Department of Anesthesia and Critical Care Medicine, School of Medicine, University Pierre and Marie Curie (UPMC), Pitié-Salpétrière Hospital, APHP, Paris, France.
²⁷ Service de Médecine Intensive-Réanimation, Université de Lyon, INSERM 955, Créteil, Hôpital de La Croix-Rousse, Hospices civils de Lyon, Lyon, France.
²⁸ Service de Réanimation, Centre Hospitalier Annecy Genevois, Annecy, France.
²⁹ Medical ICU, Hospital of Chartres, Coudray, France.
³⁰ Medical ICU, CHU d'Angers, Angers, France.
³¹ INSERM CIC 1402, Biostatistics, Université de Poitiers, Poitiers, France.

PMID: 31401603
PMCID: PMC6701687
DOI: 10.1136/bmjopen-2019-029798

Abstract

Introduction: Non-invasive ventilation (NIV) is recommended as first-line therapy in respiratory failure of critically ill immunocompromised patients as it can decrease intubation and mortality rates as compared with standard oxygen. However, its recommendation is only conditional. Indeed, the use of NIV in this setting has been challenged recently based on results of trials finding similar outcomes with or without NIV or even deleterious effects of NIV. To date, NIV has been compared with standard oxygen but not to high-flow nasal oxygen therapy (HFOT) in immunocompromised patients. Several studies have found lower mortality rates using HFOT alone than when using HFOT with NIV sessions in patients with de novo respiratory failure, and even in immunocompromised patients. We are hypothesising that HFOT alone is more effective than HFOT with NIV sessions and reduces mortality of immunocompromised patients with acute hypoxemic respiratory failure.

Methods and analysis: This study is an investigator-initiated, multicentre randomised controlled trial comparing HFOT alone or with NIV in immunocompromised patients admitted to intensive care unit (ICU) for severe acute hypoxemic respiratory failure. Around 280 patients will be randomised with a 1:1 ratio in two groups. The primary outcome is the mortality rate at day 28 after inclusion. Secondary outcomes include the rate of intubation in each group, length of ICU and hospital stay and mortality up to day 180.

Ethics and dissemination: The study has been approved by the ethics committee and patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals.

Trial registration number: NCT02978300.

Keywords: acute respiratory failure; clinical trial; high-flow nasal cannula oxygen therapy; immunosuppression; mortality; non-invasive ventilation.

PubMed Disclaimer

Conflict of interest statement

Competing interests: RC reports travel expense coverage to attend scientific meetings from Fisher & Paykel and MSD. JPF reports travel expense coverage to attend scientific meetings and personal fees from Fisher & Paykel and SOS Oxygène. SE reports consulting fees from Aerogen, La diffusion technique française, Baxter, Bayer, lecture fees from Aerogen, Fisher & Paykel, unrestricted research grants / research support from from Fisher & Paykel, Hamilton medical, Aerogen, La diffusion technique française. Chr G reports travel expense coverage to attend scientific meetings, personal fees and logistic support from Fisher & Paykel, Resmed and Lowenstein Medical. AWT reports travel expense coverage to attend scientific meetings and payment for lectures from Fisher & Paykel, Covidien, Maquet-Getinge, General Electric Healthcare. SJ reports personal fees for lectures from Hamilton Medical and Nihon Kohden. GG reports payment for lectures from Getinge, Draeger Medical, Pfizer, Fisher&Paykel, and travel / accommodation/congress registration support from Biotest and Getinge.

Figures

**Figure 1**
Flowchart of the patients and study design. HFOT, high-flow nasal oxygen therapy; ICU, intensive care unit; NIV, non-invasive ventilation; PBW, predicted body weight; PEEP, positiveend-expiratory pressure; Vte, expired tidal volume

**Figure 2**
Flowchart of timing in collection of different variables. FiO₂, fraction of inspired oxygen; HFOT, high-flow nasal oxygen therapy; ICU, intensive care unit; NIV, non-invasive ventilation; PaO₂, PaO₂ of arterial oxygen; PaCO₂, PaO₂ of arterial carbon dioxide; SpO₂, peripheral capillary oxygen saturation.

See this image and copyright information in PMC

References

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High-flow nasal oxygen therapy alone or with non-invasive ventilation in immunocompromised patients admitted to ICU for acute hypoxemic respiratory failure: the randomised multicentre controlled FLORALI-IM protocol

Affiliations

High-flow nasal oxygen therapy alone or with non-invasive ventilation in immunocompromised patients admitted to ICU for acute hypoxemic respiratory failure: the randomised multicentre controlled FLORALI-IM protocol

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Associated data

LinkOut - more resources

Full Text Sources

Medical