Benefits of Optiflow® Device for Preoxygenation Before Intubation in Acute Hypoxemic Respiratory Failure : The PREOXYFLOW Study

Nantes University Hospital122 enrolled

Overview

Oro-tracheal intubation in intensive unit care(ICU) in acute hypoxemic respiratory failure after crash induction remains a critical event. The aim of this study is to determine whether Nasal High Flow Therapy (HFT) Optiflow ® is more efficient than the face mask for preoxygenation before orotracheal intubation after crash induction in acute hypoxemic respiratory failure

This study will be designed as followed : Patients will be randomized in 2 groups :"PREOXYFLOW" or "STANDARD FACE MASK". Patients randomized in "PREOXYFLOW" group will received a four minutes preoxygenation period with Nasal High Flow Therapy (HFT) (60 l/mn FIO2 = 1) before orotracheal intubation under laryngoscopy after crash induction. Patients randomized in "STANDARD FACE MASK" group will received a four minutes preoxygenation period with standard face mask (15 l/mn) before orotracheal intubation under laryngoscopy after crash induction

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

122

Conditions

Acute Hypoxemic Respiratory Failure

Interventions

PREOXYFLOWDEVICE

Patients randomized in "PREOXYFLOW" group will received a four minutes preoxygenation period with Nasal High Flow Therapy (HFT) Optiflow ® (60 l/mn FIO2 = 1) before orotracheal intubation under laryngoscopy after crash induction

STANDARD FACE MASKPROCEDURE

Patients randomized in "STANDARD FACE MASK" group will received a four minutes preoxygenation period with a standard face mask (15 l/mn) before orotracheal intubation under laryngoscopy after crash induction. Each hospital involved in this study will use the standard face mask as per its usual practice (no specific trademark requested by this protocol)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults older than 18 years regardless of the gender * Acute hypoxemic respiratory failure defined as : Respiratory rate \> 30/mn AND Hypoxemia with SpO2 \<90% with oxygen supply \> FiO2 0,5 AND PaO2/FiO2 \<300 mmHg Exclusion Criteria: * Contraindication to oro-tracheal intubation * Intubation without anesthetic delivery * Intubation during cardiac arrest * Asphyxia with immediate intubation needed * Nasopharyngeal obstacle with contraindication to use Optiflow device * Patients with a documented Cormack IV exposition before inclusion * Protected adult * Pregnancy * Lack of consent * Patient already enrolled in an other randomized study.

Locations (6)

Nantes Universitary Hospital, medical intensive care unit

Nantes, Loire Atlantique, France

Angers Universitary Hospital

Angers, France

Brest Universitary Hospital

Brest, France

La Roche/Yon Hospital

La Roche/Yon, France

Outcomes

Primary Outcomes

to determine whether Optiflow® used during the preoxygenation period before orotracheal intubation after crash induction is more efficient than standard face mask.

This outcome will be assessed from the beginning of the preoxygenation period to the end of orotracheal intubation by monitoring the pulse oxymetry

Time frame: 4 minutes

Secondary Outcomes

Improvement of quality of preoxygenation

Time frame: 4 minutes

Reduction in side effects incidence related to intubation

Time frame: 1 hour

Reduction in Organ failure in the 5th day

Time frame: at day 5

Reduction in morbi-mortality during the Intensive Care Unit stay.

Time frame: until day 28 OR, if patient still in the intensive care unit (ICU) at Day 28, until discharge of ICU

Data from ClinicalTrials.gov

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