Comparison of Pre-oxygenation of NIV and HFNC Therapy for Intubation of ICU Patients With Acute Respiratory Failure
FLORALI2
1 other identifier
interventional
320
1 country
27
Brief Summary
The aim of the study is to evaluate the incidence of severe hypoxemia episodes during the intubation procedure with two methods of pre-oxygenation:
- 1.NIV (Non Invasive Ventilation)
- 2.HFNC (High-flow nasal canula oxygen therapy)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2016
Shorter than P25 for not_applicable
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2016
CompletedFirst Posted
Study publicly available on registry
January 29, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedOctober 11, 2017
October 1, 2017
8 months
January 19, 2016
October 10, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Severe desaturation as defined by a pulse oxymetry below 80%
drop below 80% of pulse oxymetry measurement
through five minutes after preoxygenation period
Study Arms (2)
NIV
EXPERIMENTALNIV group, preoxygenation by NIV: pressure support set for an exhaled tidal volume of 6-8 ml / kg of ideal body weight, PEEP of 5 cm H2O and FiO2 at 100%.
HFNC
ACTIVE COMPARATORHigh-flow nasal canula oxygen therapy. NHFC group, preoxygenation by NHFC: oxygen flow rate of 60 L / min and 100% FiO2
Interventions
Pre-oxygenation with high-flow nasal canula oxygen therapy
Eligibility Criteria
You may qualify if:
- acute hypoxemic respiratory failure requiring endotracheal intubation
You may not qualify if:
- coma
- NIV contraindication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
CHU Angers
Angers, France
CHU La cavale Blanche
Brest, France
CHU louis MOURIER
Colombes, France
Chu Mondor
Créteil, France
CHU Dijon
Dijon, France
CH Vendée
La Roche/Yon, France
CH La Rochelle
La Rochelle, France
CHU Lille
Lille, France
Limoges University Hospital
Limoges, 87042, France
CH St Joseph St Luc
Lyon, France
Chu E. Herriot
Lyon, France
LYON Sud
Lyon, France
CHU marseille
Marseille, France
CH
Montauban, France
CHU Lapeyronie
Montpellier, France
Hopital de l'Archet
Nice, France
CHU La Source
Orléans, France
Chu Cochin
Paris, France
CHU La Pitié Salpétrière
Paris, France
Chu Tenon
Paris, France
CHU Guadeloupe
Pointe à Pitre, France
CHU Poitiers
Poitiers, 86000, France
University Hospital of Poitiers
Poitiers, 86021, France
Hôpital C. NICOLLE
Rouen, France
CHU Strasbourg
Strasbourg, France
Hôpital FOCH
Suresnes, France
Chu Tours
Tours, France
Related Publications (3)
Rodriguez M, Ragot S, Coudroy R, Quenot JP, Vignon P, Forel JM, Demoule A, Mira JP, Ricard JD, Nseir S, Colin G, Pons B, Danin PE, Devaquet J, Prat G, Merdji H, Petitpas F, Vivier E, Mekontso-Dessap A, Nay MA, Asfar P, Dellamonica J, Argaud L, Ehrmann S, Fartoukh M, Girault C, Robert R, Thille AW, Frat JP; REVA Network. Noninvasive ventilation vs. high-flow nasal cannula oxygen for preoxygenation before intubation in patients with obesity: a post hoc analysis of a randomized controlled trial. Ann Intensive Care. 2021 Jul 22;11(1):114. doi: 10.1186/s13613-021-00892-8.
PMID: 34292408DERIVEDFrat JP, Ricard JD, Quenot JP, Pichon N, Demoule A, Forel JM, Mira JP, Coudroy R, Berquier G, Voisin B, Colin G, Pons B, Danin PE, Devaquet J, Prat G, Clere-Jehl R, Petitpas F, Vivier E, Razazi K, Nay MA, Souday V, Dellamonica J, Argaud L, Ehrmann S, Gibelin A, Girault C, Andreu P, Vignon P, Dangers L, Ragot S, Thille AW; FLORALI-2 study group; REVA network. Non-invasive ventilation versus high-flow nasal cannula oxygen therapy with apnoeic oxygenation for preoxygenation before intubation of patients with acute hypoxaemic respiratory failure: a randomised, multicentre, open-label trial. Lancet Respir Med. 2019 Apr;7(4):303-312. doi: 10.1016/S2213-2600(19)30048-7. Epub 2019 Mar 18.
PMID: 30898520DERIVEDFrat JP, Ricard JD, Coudroy R, Robert R, Ragot S, Thille AW; on-behalf-of REVA network. 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 Dec 22;7(12):e018611. doi: 10.1136/bmjopen-2017-018611.
PMID: 29275345DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2016
First Posted
January 29, 2016
Study Start
April 1, 2016
Primary Completion
December 1, 2016
Study Completion
January 1, 2017
Last Updated
October 11, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share