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

Acute Respiratory Failure Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02668458
• Other study ID #: FLORALI 2
• Status: Completed
• Phase: N/A
• First received: January 19, 2016
• Last updated: October 10, 2017
• Start date: April 2016
• Est. completion date: January 2017

Study information

• Verified date: October 2017
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Main inclusion Criteria:

• acute hypoxemic respiratory failure requiring endotracheal intubation

Main exclusion Criteria:

• coma

• NIV contraindication

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Intratracheal Intubation
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Procedure:
• High Flow nasal canula oxygen therapy
Pre-oxygenation with high-flow nasal canula oxygen therapy
• Noninvasive ventilation
Pre-oxygenation with non-invasive ventilation

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	CHU La cavale Blanche	Brest
France	CHU louis MOURIER	Colombes
France	Chu Mondor	Creteil
France	CHU Dijon	Dijon
France	CH Vendée	La Roche/Yon
France	CH La Rochelle	La Rochelle
France	CHU Lille	Lille
France	Limoges University Hospital	Limoges
France	CH St Joseph St Luc	Lyon
France	Chu E. Herriot	Lyon
France	LYON Sud	Lyon
France	CHU marseille	Marseille
France	CH	Montauban
France	CHU Lapeyronie	Montpellier
France	Hopital de l'Archet	Nice
France	CHU La Source	Orleans
France	Chu Cochin	Paris
France	CHU La Pitié Salpétrière	Paris
France	Chu Tenon	Paris
France	CHU Guadeloupe	POINTE à PITRE
France	CHU Poitiers	Poitiers
France	University Hospital of Poitiers	Poitiers
France	Hôpital C. NICOLLE	Rouen
France	CHU Strasbourg	Strasbourg
France	Hôpital FOCH	Suresnes
France	Chu Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severe desaturation as defined by a pulse oxymetry below 80%	drop below 80% of pulse oxymetry measurement	through five minutes after preoxygenation period