Clinical trial NCT02668458: Comparison of Pre-oxygenation of NIV and HFNC Therapy for Intubation of ICU Patients With Acute Respiratory Failure
Official title: Comparison of Pre-oxygenation by Non-invasive Ventilation With High-flow Nasal Oxygen Therapy for Intubation of Intensive Care Patients in Cases of Acute Respiratory Failure: A Prospective, Randomized, Controlled Study (FLORALI 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Failure
Intratracheal Intubation
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2016-01-29
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Detailed description: Design:

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

Eligibility criteria: Main inclusion Criteria:

* acute hypoxemic respiratory failure requiring endotracheal intubation

Main exclusion Criteria:

* coma
* NIV contraindication

Primary outcomes:
measure: Severe desaturation as defined by a pulse oxymetry below 80%
timeFrame: through five minutes after preoxygenation period
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Brest
country: France
facility: CHU La cavale Blanche
city: Colombes
country: France
facility: CHU louis MOURIER
city: Creteil
country: France
facility: Chu Mondor
city: Dijon
country: France
facility: CHU Dijon
city: La Roche/Yon
country: France
facility: CH Vendée
city: La Rochelle
country: France
facility: CH La Rochelle
city: Lille
country: France
facility: CHU Lille
city: Limoges
country: France
facility: Limoges University Hospital
city: Lyon
country: France
facility: CH St Joseph St Luc
city: Lyon
country: France
facility: Chu E. Herriot
city: Lyon
country: France
facility: LYON Sud
city: Marseille
country: France
facility: CHU marseille
city: Montauban
country: France
facility: CH
city: Montpellier
country: France
facility: CHU Lapeyronie
city: Nice
country: France
facility: Hopital de l'Archet
city: Orleans
country: France
facility: CHU La Source
city: Paris
country: France
facility: Chu Cochin
city: Paris
country: France
facility: CHU La Pitié Salpétrière
city: Paris
country: France
facility: Chu Tenon
city: POINTE à PITRE
country: France
facility: CHU Guadeloupe
city: Poitiers
country: France
facility: CHU Poitiers
city: Poitiers
country: France
facility: University Hospital of Poitiers
city: Rouen
country: France
facility: Hôpital C. NICOLLE
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Suresnes
country: France
facility: Hôpital FOCH
city: Tours
country: France
facility: Chu Tours
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.