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Preoxygenation with non-invasive ventilation versus high-flow nasal cannula oxygen therapy for intubation of patients with acute hypoxaemic respiratory failure in ICU: the prospective randomised controlled FLORALI-2 study protocol.
BMJ Open. 2017 12 22; 7(12):e018611.BO

Abstract

INTRODUCTION

Endotracheal intubation in intensive care unit (ICU) is a procedure at high risk of life-threatening complications. Among them, severe oxygen desaturation, usually defined as a drop of pulse oxymetry (SpO2) below 80%, is the most common. Preoxygenation enables delaying oxygen desaturation occurring during apnea induced by anaesthetic drugs. Data suggest that non-invasive ventilation (NIV) or high-flow nasal cannula (HFNC) oxygen therapy could further increase PaO2 before intubation procedure and prevent oxygen desaturation episodes as compared with standard oxygen. However, no recommendation favours one technique rather than the other, since they have never been compared. Hence, whether a strategy of preoxygenation with NIV or HFNC is more effective than the other in patients with acute hypoxaemic respiratory failure remains to be established.

METHODS AND ANALYSIS

The FLORALI-2 study is a multicentre randomised controlled trial comparing a preoxygenation strategy with either NIV or HFNC in patients with acute hypoxaemic respiratory failure needing intubation in ICU. The 320 patients will be randomised with a ratio 1:1 in two groups according to the strategy of preoxygenation. The primary outcome is the occurrence of an episode of severe oxygen desaturation defined by a drop of SpO2 below 80% during the intubation procedure. Secondary outcomes include feasibility of the two strategies, immediate and late complications related to intubation.

ETHICS AND DISSEMINATION

The study has been approved by the central ethics committee (Ethics Committee Ouest-III, Poitiers, France) and patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals.

TRIAL REGISTRATION NUMBER

NCT02668458; Pre-results.

Authors+Show Affiliations

Réanimation Médicale, CHU de Poitiers, Poitiers, France. Faculté de Médecine et de Pharmacie de Poitiers, Université de Poitiers, Poitiers, France. INSERM, CIC-1402, équipe 5 ALIVE, Poitiers, France.Service de Réanimation Médico-Chirurgicale, AP-HP, Hôpital Louis Mourier, Colombes, France. Université Paris Diderot, UMR IAME 1137, Sorbonne Paris Cité, Paris, France. INSERM, IAME 1137, Paris, France.Réanimation Médicale, CHU de Poitiers, Poitiers, France. Faculté de Médecine et de Pharmacie de Poitiers, Université de Poitiers, Poitiers, France. INSERM, CIC-1402, équipe 5 ALIVE, Poitiers, France.Réanimation Médicale, CHU de Poitiers, Poitiers, France. Faculté de Médecine et de Pharmacie de Poitiers, Université de Poitiers, Poitiers, France. INSERM, CIC-1402, équipe 5 ALIVE, Poitiers, France.Faculté de Médecine et de Pharmacie de Poitiers, Université de Poitiers, Poitiers, France. Department of Biostatistics, INSERM, CIC-1402, Poitiers, France. CIC-1402, Poitiers, France.Réanimation Médicale, CHU de Poitiers, Poitiers, France. Faculté de Médecine et de Pharmacie de Poitiers, Université de Poitiers, Poitiers, France. INSERM, CIC-1402, équipe 5 ALIVE, Poitiers, France.No affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

29275345

Citation

Frat, Jean-Pierre, et al. "Preoxygenation With Non-invasive Ventilation Versus High-flow Nasal Cannula Oxygen Therapy for Intubation of Patients With Acute Hypoxaemic Respiratory Failure in ICU: the Prospective Randomised Controlled FLORALI-2 Study Protocol." BMJ Open, vol. 7, no. 12, 2017, pp. e018611.
Frat JP, Ricard JD, Coudroy R, et al. Preoxygenation with non-invasive ventilation versus high-flow nasal cannula oxygen therapy for intubation of patients with acute hypoxaemic respiratory failure in ICU: the prospective randomised controlled FLORALI-2 study protocol. BMJ Open. 2017;7(12):e018611.
Frat, J. P., Ricard, J. D., Coudroy, R., Robert, R., Ragot, S., & Thille, A. W. (2017). Preoxygenation with non-invasive ventilation versus high-flow nasal cannula oxygen therapy for intubation of patients with acute hypoxaemic respiratory failure in ICU: the prospective randomised controlled FLORALI-2 study protocol. BMJ Open, 7(12), e018611. https://doi.org/10.1136/bmjopen-2017-018611
Frat JP, et al. Preoxygenation With Non-invasive Ventilation Versus High-flow Nasal Cannula Oxygen Therapy for Intubation of Patients With Acute Hypoxaemic Respiratory Failure in ICU: the Prospective Randomised Controlled FLORALI-2 Study Protocol. BMJ Open. 2017 12 22;7(12):e018611. PubMed PMID: 29275345.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Preoxygenation with non-invasive ventilation versus high-flow nasal cannula oxygen therapy for intubation of patients with acute hypoxaemic respiratory failure in ICU: the prospective randomised controlled FLORALI-2 study protocol. AU - Frat,Jean-Pierre, AU - Ricard,Jean-Damien, AU - Coudroy,Rémi, AU - Robert,René, AU - Ragot,Stéphanie, AU - Thille,Arnaud W, AU - ,, Y1 - 2017/12/22/ PY - 2017/12/25/entrez PY - 2017/12/25/pubmed PY - 2018/8/16/medline KW - adult thoracic medicine KW - clinical trials SP - e018611 EP - e018611 JF - BMJ open JO - BMJ Open VL - 7 IS - 12 N2 - INTRODUCTION: Endotracheal intubation in intensive care unit (ICU) is a procedure at high risk of life-threatening complications. Among them, severe oxygen desaturation, usually defined as a drop of pulse oxymetry (SpO2) below 80%, is the most common. Preoxygenation enables delaying oxygen desaturation occurring during apnea induced by anaesthetic drugs. Data suggest that non-invasive ventilation (NIV) or high-flow nasal cannula (HFNC) oxygen therapy could further increase PaO2 before intubation procedure and prevent oxygen desaturation episodes as compared with standard oxygen. However, no recommendation favours one technique rather than the other, since they have never been compared. Hence, whether a strategy of preoxygenation with NIV or HFNC is more effective than the other in patients with acute hypoxaemic respiratory failure remains to be established. METHODS AND ANALYSIS: The FLORALI-2 study is a multicentre randomised controlled trial comparing a preoxygenation strategy with either NIV or HFNC in patients with acute hypoxaemic respiratory failure needing intubation in ICU. The 320 patients will be randomised with a ratio 1:1 in two groups according to the strategy of preoxygenation. The primary outcome is the occurrence of an episode of severe oxygen desaturation defined by a drop of SpO2 below 80% during the intubation procedure. Secondary outcomes include feasibility of the two strategies, immediate and late complications related to intubation. ETHICS AND DISSEMINATION: The study has been approved by the central ethics committee (Ethics Committee Ouest-III, Poitiers, France) and patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT02668458; Pre-results. SN - 2044-6055 UR - https://www.unboundmedicine.com/medline/citation/29275345/Preoxygenation_with_non_invasive_ventilation_versus_high_flow_nasal_cannula_oxygen_therapy_for_intubation_of_patients_with_acute_hypoxaemic_respiratory_failure_in_ICU:_the_prospective_randomised_controlled_FLORALI_2_study_protocol_ L2 - https://bmjopen.bmj.com/lookup/pmidlookup?view=long&pmid=29275345 DB - PRIME DP - Unbound Medicine ER -