Comparison of Pre-oxygenation of NIV and HFNC Therapy for Intubation of ICU Patients With Acute Respiratory Failure (FLORALI2)
Primary Purpose
Acute Respiratory Failure, Intratracheal Intubation
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
High Flow nasal canula oxygen therapy
Noninvasive ventilation
Sponsored by
About this trial
This is an interventional treatment trial for Acute Respiratory Failure
Eligibility Criteria
Main inclusion Criteria:
- acute hypoxemic respiratory failure requiring endotracheal intubation
Main exclusion Criteria:
- coma
- NIV contraindication
Sites / Locations
- CHU Angers
- CHU La cavale Blanche
- CHU louis MOURIER
- Chu Mondor
- CHU Dijon
- CH Vendée
- CH La Rochelle
- CHU Lille
- Limoges University Hospital
- CH St Joseph St Luc
- Chu E. Herriot
- LYON Sud
- CHU marseille
- CH
- CHU Lapeyronie
- Hopital de l'Archet
- CHU La Source
- Chu Cochin
- CHU La Pitié Salpétrière
- Chu Tenon
- CHU Guadeloupe
- CHU Poitiers
- University Hospital of Poitiers
- Hôpital C. NICOLLE
- CHU Strasbourg
- Hôpital FOCH
- Chu Tours
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NIV
HFNC
Arm Description
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%.
High-flow nasal canula oxygen therapy. NHFC group, preoxygenation by NHFC: oxygen flow rate of 60 L / min and 100% FiO2
Outcomes
Primary Outcome Measures
Severe desaturation as defined by a pulse oxymetry below 80%
drop below 80% of pulse oxymetry measurement
Secondary Outcome Measures
Full Information
NCT ID
NCT02668458
First Posted
January 19, 2016
Last Updated
October 10, 2017
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02668458
Brief Title
Comparison of Pre-oxygenation of NIV and HFNC Therapy for Intubation of ICU Patients With Acute Respiratory Failure
Acronym
FLORALI2
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
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
NIV (Non Invasive Ventilation)
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure, Intratracheal Intubation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NIV
Arm Type
Experimental
Arm Description
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%.
Arm Title
HFNC
Arm Type
Active Comparator
Arm Description
High-flow nasal canula oxygen therapy. NHFC group, preoxygenation by NHFC: oxygen flow rate of 60 L / min and 100% FiO2
Intervention Type
Procedure
Intervention Name(s)
High Flow nasal canula oxygen therapy
Intervention Description
Pre-oxygenation with high-flow nasal canula oxygen therapy
Intervention Type
Procedure
Intervention Name(s)
Noninvasive ventilation
Intervention Description
Pre-oxygenation with non-invasive ventilation
Primary Outcome Measure Information:
Title
Severe desaturation as defined by a pulse oxymetry below 80%
Description
drop below 80% of pulse oxymetry measurement
Time Frame
through five minutes after preoxygenation period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main inclusion Criteria:
acute hypoxemic respiratory failure requiring endotracheal intubation
Main exclusion Criteria:
coma
NIV contraindication
Facility Information:
Facility Name
CHU Angers
City
Angers
Country
France
Facility Name
CHU La cavale Blanche
City
Brest
Country
France
Facility Name
CHU louis MOURIER
City
Colombes
Country
France
Facility Name
Chu Mondor
City
Creteil
Country
France
Facility Name
CHU Dijon
City
Dijon
Country
France
Facility Name
CH Vendée
City
La Roche/Yon
Country
France
Facility Name
CH La Rochelle
City
La Rochelle
Country
France
Facility Name
CHU Lille
City
Lille
Country
France
Facility Name
Limoges University Hospital
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
CH St Joseph St Luc
City
Lyon
Country
France
Facility Name
Chu E. Herriot
City
Lyon
Country
France
Facility Name
LYON Sud
City
Lyon
Country
France
Facility Name
CHU marseille
City
Marseille
Country
France
Facility Name
CH
City
Montauban
Country
France
Facility Name
CHU Lapeyronie
City
Montpellier
Country
France
Facility Name
Hopital de l'Archet
City
Nice
Country
France
Facility Name
CHU La Source
City
Orleans
Country
France
Facility Name
Chu Cochin
City
Paris
Country
France
Facility Name
CHU La Pitié Salpétrière
City
Paris
Country
France
Facility Name
Chu Tenon
City
Paris
Country
France
Facility Name
CHU Guadeloupe
City
POINTE à PITRE
Country
France
Facility Name
CHU Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
University Hospital of Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Hôpital C. NICOLLE
City
Rouen
Country
France
Facility Name
CHU Strasbourg
City
Strasbourg
Country
France
Facility Name
Hôpital FOCH
City
Suresnes
Country
France
Facility Name
Chu Tours
City
Tours
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34292408
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.
Results Reference
derived
PubMed Identifier
30898520
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.
Results Reference
derived
PubMed Identifier
29275345
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.
Results Reference
derived
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Comparison of Pre-oxygenation of NIV and HFNC Therapy for Intubation of ICU Patients With Acute Respiratory Failure
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