Comparison of Pre-oxygenation of NIV and HFNC Therapy for Intubation of ICU Patients With Acute Respiratory Failure
NCT ID: NCT02668458
Last Updated: 2017-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
320 participants
INTERVENTIONAL
2016-04-30
2017-01-31
Brief Summary
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1. NIV (Non Invasive Ventilation)
2. HFNC (High-flow nasal canula oxygen therapy)
Detailed Description
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Clinical randomized, open, multicenter, comparative trial, with parallel groups aimed at evaluating a medical device.
Selection of patients admitted to the ICU for acute respiratory failure, requiring endotracheal intubation.
Randomized study, inclusion in two groups: NIV or HFNC.
Experimental group:
NHFC group, preoxygenation by NHFC: oxygen flow rate of 60 L / min and 100% FiO2.
Control group:
NIV 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%.
Duration of participation of each patient: 28 days
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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NIV
NIV 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%.
Noninvasive ventilation
Pre-oxygenation with non-invasive ventilation
HFNC
High-flow nasal canula oxygen therapy. NHFC group, preoxygenation by NHFC: oxygen flow rate of 60 L / min and 100% FiO2
High Flow nasal canula oxygen therapy
Pre-oxygenation with high-flow nasal canula oxygen therapy
Interventions
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High Flow nasal canula oxygen therapy
Pre-oxygenation with high-flow nasal canula oxygen therapy
Noninvasive ventilation
Pre-oxygenation with non-invasive ventilation
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* NIV contraindication
18 Years
ALL
No
Sponsors
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Poitiers University Hospital
OTHER
Responsible Party
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Locations
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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, , 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, , France
University Hospital of Poitiers
Poitiers, , France
Hôpital C. NICOLLE
Rouen, , France
CHU Strasbourg
Strasbourg, , France
Hôpital FOCH
Suresnes, , France
Chu Tours
Tours, , France
Countries
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References
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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.
Frat 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.
Frat 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.
Other Identifiers
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FLORALI 2
Identifier Type: -
Identifier Source: org_study_id