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

Not Applicable

Completed

• Conditions: Acute Hypoxemic Respiratory Failure
• Interventions: Device: PREOXYFLOW; Procedure: STANDARD FACE MASK

• Registration Number: NCT01747109
• Lead Sponsor: Nantes University Hospital

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-12-04
• Study First Submitted QC: 2012-12-10
• Study First Posted: 2012-12-11
• Primary Completion: 2013-07
• Study Completion: 2013-08
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-09
• Last Update Posted: 2013-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PREOXYFLOW	PREOXYFLOW	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 MASK	STANDARD FACE MASK	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. No specific trademark is requested by the protocol.

Primary Outcome Measures

Name	Time	Method
to determine whether Optiflow® used during the preoxygenation period before orotracheal intubation after crash induction is more efficient than standard face mask.	4 minutes	This outcome will be assessed from the beginning of the preoxygenation period to the end of orotracheal intubation by monitoring the pulse oxymetry

Secondary Outcome Measures

Name	Time	Method
Reduction in Organ failure in the 5th day	at day 5
Improvement of quality of preoxygenation	4 minutes
Reduction in side effects incidence related to intubation	1 hour
Reduction in morbi-mortality during the Intensive Care Unit stay.	until day 28 OR, if patient still in the intensive care unit (ICU) at Day 28, until discharge of ICU

Trial Locations

Locations (6)

Angers Universitary Hospital; 🇫🇷 Angers, France

La Roche/Yon Hospital; 🇫🇷 La Roche/Yon, France

Nantes Universitary Hospital, medical intensive care unit; 🇫🇷 Nantes, Loire Atlantique, France

Brest Universitary Hospital; 🇫🇷 Brest, France

Montpellier University hospital; 🇫🇷 Montpellier, France

Nantes Universitary Hospital, surgical intensive care unit; 🇫🇷 Nantes, France