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

Acute Hypoxemic Respiratory Failure Clinical Trial

— PREOXYFLOW  

Official title:

A Prospective, Multicenter, Randomized, Controlled, Parallel-group, Open Label Trial Evaluating Benefits of Nasal High Flow Therapy (HFT) in Preoxygenation Before Tracheal Intubation in Acute Hypoxemic Respiratory Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01747109
• Other study ID #: RC12_0178
• Status: Completed
• Phase: N/A
• First received: December 4, 2012
• Last updated: December 9, 2013
• Start date: November 2012
• Est. completion date: August 2013

Study information

• Verified date: December 2013
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Hypoxemic Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• 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

Procedure:
• 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. Each hospital involved in this study will use the standard face mask as per its usual practice (no specific trademark requested by this protocol)

Locations

Country	Name	City	State
France	Angers Universitary Hospital	Angers
France	Brest Universitary Hospital	Brest
France	La Roche/Yon Hospital	La Roche/Yon
France	Montpellier University hospital	Montpellier
France	Nantes Universitary Hospital, medical intensive care unit	Nantes	Loire Atlantique
France	Nantes Universitary Hospital, surgical intensive care unit	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 minutes	No
Secondary	Improvement of quality of preoxygenation		4 minutes	No
Secondary	Reduction in side effects incidence related to intubation		1 hour	Yes
Secondary	Reduction in Organ failure in the 5th day		at day 5	Yes
Secondary	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	Yes