Comparison of Pre-oxygenation of NIV and HFNC Therapy for Intubation of ICU Patients With Acute Respiratory Failure (FLORALI2)

Poitiers University Hospital

Status: Completed

Conditions: Intratracheal Intubation; Acute Respiratory Failure

Treatments: Procedure: High Flow nasal canula oxygen therapy; Procedure: Noninvasive ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT02668458

FLORALI 2

Details and patient eligibility

About

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)

Full 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

Enrollment: 320 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main inclusion Criteria:

• acute hypoxemic respiratory failure requiring endotracheal intubation

Main exclusion Criteria:

• coma
• NIV contraindication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

NIV

Experimental group

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%.

Treatment:

Procedure: Noninvasive ventilation

HFNC

Active Comparator group

Description:

High-flow nasal canula oxygen therapy. NHFC group, preoxygenation by NHFC: oxygen flow rate of 60 L / min and 100% FiO2

Treatment:

Procedure: High Flow nasal canula oxygen therapy