Title :

High-flow nasal oxygen vs. standard oxygen therapy in immunocompromised patients with acute respiratory failure: study protocol for a randomized controlled trial

Author(s) :

Azoulay, Elie [Auteur]
Université Paris Diderot, Sorbonne Paris Cité, Paris, France
Lemiale, Virginie [Auteur]
Université Paris Diderot, Sorbonne Paris Cité, Paris, France
Mokart, Djamel [Auteur]
Nseir, Saad [Auteur]
Lille Inflammation Research International Center (LIRIC) - U995
Arnaud, Laurent [Auteur]
Pene, Frederic [Auteur]
Université Paris Descartes - Paris 5 [UPD5]
Kontar, Loay [Auteur]
Bruneel, Fabrice [Auteur]
Klouche, Kada [Auteur]
Barbier, Francois [Auteur]
Reignier, Jean [Auteur]
Stoclin, Anabelle [Auteur]
Louis, Guillaume [Auteur]
Constantin, Jean-Michel [Auteur]
Mayaux, Julien [Auteur]
Université Pierre et Marie Curie - Paris 6 [UPMC]
Wallet, Florent [Auteur]
Kouatchet, Achille [Auteur]
Peigne, Vincent [Auteur]
Perez, Pierre [Auteur]
Girault, Christophe [Auteur]
Jaber, Samir [Auteur]
Oziel, Johanna [Auteur]
Nyunga, Martine [Auteur]
Terzi, Nicolas [Auteur]
Bouadma, Lila [Auteur]
Lebert, Christine [Auteur]
Lautrette, Alexandre [Auteur]
Bige, Naike [Auteur]
Raphalen, Jean-Herle [Auteur]
Papazian, Laurent [Auteur]
Aix Marseille Université [AMU]
Rabbat, Antoine [Auteur]
Darmon, Michael [Auteur]
Chevret, Sylvie [Auteur]
Demoule, Alexandre [Auteur]
Université Pierre et Marie Curie - Paris 6 [UPMC]

Journal title :

Trials

Abbreviated title :

Trials

Volume number :

19

Publication date :

2018-03-05

Keyword(s) :

Oxygen
Acute respiratory failure
Immunocompromised Hematology
High-flow oxygen
Mortality
Intubation
Immunosuppression

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

Background: Acute respiratory failure (ARF) is the leading reason for intensive care unit (ICU) admission in immunocompromised patients. High-flow nasal oxygen (HFNO) therapy is an alternative to standard oxygen. By providing ...
Show more >Background: Acute respiratory failure (ARF) is the leading reason for intensive care unit (ICU) admission in immunocompromised patients. High-flow nasal oxygen (HFNO) therapy is an alternative to standard oxygen. By providing warmed and humidified gas, HFNO allows the delivery of higher flow rates via nasal cannula devices, with FiO2 values of nearly 100%. Benefits include alleviation of dyspnea and discomfort, decreased respiratory distress and decreased mortality in unselected patients with acute hypoxemic respiratory failure. However, in preliminary reports, HFNO benefits are controversial in immunocompromised patients in whom it has never been properly evaluated. Methods/design: This is a multicenter, open-label, randomized controlled superiority trial in 30 intensive care units, part of the Groupe de Recherche Respiratoire en Réanimation Onco-Hématologique (GRRR-OH). Inclusion criteria will be: (1) adults, (2) known immunosuppression, (3) ARF, (4) oxygen therapy ≥ 6 L/min, (5) written informed consent from patient or proxy. Exclusion criteria will be: (1) imminent death (moribund patient), (2) no informed consent, (3) hypercapnia (PaCO2 ≥ 50 mmHg), (4) isolated cardiogenic pulmonary edema, (5) pregnancy or breastfeeding, (6) anatomical factors precluding insertion of a nasal cannula, (7) no coverage by the French statutory healthcare insurance system, and (8) post-surgical setting from day 1 to day 6 (patients with ARF occurring after day 6 of surgery can be included).: The primary outcome measure is day-28 mortality. Secondary outcomes are intubation rate, comfort, dyspnea, respiratory rate, oxygenation, ICU length of stay, and ICU-acquired infections. Based on an expected 30% mortality rate in the standard oxygen group, and 20% in the HFNO group, error rate set at 5%, and a statistical power at 90%, 389 patients are required in each treatment group (778 patients overall). Recruitment period is estimated at 30 months, with 28 days of additional follow-up for the last included patient.Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

Inserm
Université de Lille
CHU Lille

Collections :

• Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286

Research team(s) :

Fungal associated invasive and inflammatory diseases

Submission date :

2019-03-01T14:34:48Z
2024-01-29T15:28:23Z