Completed

NCT Number: NCT02668458

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

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)

Completed

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Key information

Conditions

Acute Respiratory Failure Intratracheal Intubation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Angers, Angers, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main inclusion Criteria:

acute hypoxemic respiratory failure requiring endotracheal intubation

Main exclusion Criteria:

coma
NIV contraindication

Treatment and study plan

High Flow nasal canula oxygen therapy

Procedure

Pre-oxygenation with high-flow nasal canula oxygen therapy

Noninvasive ventilation

Procedure

Pre-oxygenation with non-invasive ventilation

Primary outcomes

Severe desaturation as defined by a pulse oxymetry below 80%

Time frame: through five minutes after preoxygenation period

drop below 80% of pulse oxymetry measurement

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study 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)

Acronym: FLORALI2

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2017
First posted: Jan 29, 2016
Registry last updated: Oct 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed