Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT02668458
Status:
COMPLETED
Last Update Posted:
2017-10-11
First Post:
2016-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Pre-oxygenation of NIV and HFNC Therapy for Intubation of ICU Patients With Acute Respiratory Failure
Sponsor:
Poitiers University Hospital
Organization:
Study Overview
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)
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FLORALI2
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)
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: