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

P

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)

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

Trial contacts and locations

27

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Data sourced from clinicaltrials.gov

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