Skip to content

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

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02668458
Acronym
FLORALI2
Enrollment
320
Registered
2016-01-29
Start date
2016-04-30
Completion date
2017-01-31
Last updated
2017-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure, Intratracheal Intubation

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

Interventions

PROCEDUREHigh Flow nasal canula oxygen therapy

Pre-oxygenation with high-flow nasal canula oxygen therapy

PROCEDURENoninvasive ventilation

Pre-oxygenation with non-invasive ventilation

Sponsors

Poitiers University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Main inclusion Criteria: * acute hypoxemic respiratory failure requiring endotracheal intubation Main

Exclusion criteria

* coma * NIV contraindication

Design outcomes

Primary

MeasureTime frameDescription
Severe desaturation as defined by a pulse oxymetry below 80%through five minutes after preoxygenation perioddrop below 80% of pulse oxymetry measurement

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026