Benefits of High Flow Nasal Cannula Oxygen for Preoxygenation During Intubation in Non Severely Hypoxemic Patients

Not Applicable

Completed

• Conditions: Need for Intubation, No Severe Hypoxemia
• Interventions: Procedure: STANDARD Face Mask; Device: OPTIFLOW/ AIRVO

• Registration Number: NCT02700321
• Lead Sponsor: Nantes University Hospital

Brief Summary

The aim of this study is to determine whether High Flow nasal cannula (HFNC) oxygen is more efficient than the standard High Flow face mask (HFFM) for preoxygenation before orotracheal intubation after crash induction in non severely hypoxemic patients

Detailed Description

This study will be designed as followed : patients will be randomized in 2 groups : High Flow nasal cannula "HFNC" or standard High Flow face mask "HFFM".

Patients randomized in "HFNC" group will receive a four minutes preoxygenation period with Nasal High Flow Therapy (60 L/mn , fraction of inspired oxygen (FI02) = 100%) before orotracheal intubation under laryngoscopy after crash induction. After induction and during laryngoscopy, HFNC will be maintained in an attempt to achieve apneic oxygenation.

Patients randomized in "HFFM" group will received a four minutes preoxygenation period with standard face mask (15 L/mn) before orotracheal intubation under laryngoscopy after crash induction. After induction, HFFM will be removed, enabling laryngoscopic vision

Study Timeline

• Study First Submitted: 2016-02-02
• Study First Submitted QC: 2016-03-01
• Study First Posted: 2016-03-07
• Study Start: 2016-04-28
• Primary Completion: 2017-06-27
• Study Completion: 2017-10-05
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-01
• Last Update Posted: 2019-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

• Adults older than 18 years regardless of the gender
• Requiring orotracheal intubation in intensive care unit
• "No severely hypoxemic respiratory failure" defined as Oxygen Pression (Pa02)/FI02 > 200 mmHg measured in the 4 hours before inclusion

Exclusion Criteria

• Not the first Intubation during this stay in intensive care unit
• Contraindication to oro-tracheal intubation
• Intubation without anaesthesic rapid sequence induction
• Intubation during cardiac arrest
• Real emergency (as asphyxia) with immediate intubation needed (without time enough for randomization)
• Nasopharyngeal obstacle with contraindication to use Optiflow device
• Patients with a documented Cormack IV exposition before inclusion
• Protected adult
• Pregnancy or breastfeeding
• Lack of consent
• Patient already enrolled in another study that could interfere with the primary objective of this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STANDARD high flow Face Mask (HFFM)	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.
High Flow nasal cannula oxygen (HFNC)	OPTIFLOW/ AIRVO	Patients randomized in "HFNC" group will received a four minutes preoxygenation period with Nasal High Flow Therapy (HFT) Optiflow ®/Airvo® (60 l/mn FIO2 = 1) before orotracheal intubation under laryngoscopy after crash induction.

Primary Outcome Measures

Name	Time	Method
lowest pulse oxymetry (SpO2) during intubation	From the beginning of the endotracheal intubation procedure (beginning of laryngoscopy, immediately after induction) to completed orotracheal intubation (airway catheterization). Usual duration is inferior to 10 minutes	This outcome will be assessed from the beginning of the endotracheal intubation procedure (immediately after induction) to the end of orotracheal intubation (airway catheterization) by monitoring the pulse oxymetry

Secondary Outcome Measures

Name	Time	Method
SOFA score	Each day during the 5 first days after randomisation
number of desaturation events (under 80%)	From the beginning of the endotracheal intubation procedure (beginning of laryngoscopy, immediately after induction) to completed orotracheal intubation (airway catheterization). Usual duration is inferior to 10 minutes)
Pulse oximetry	from the beginning of preoxygenation period to the end of intubation procedure. Usual duration is inferior to 15 minutes
Reduction in morbi-mortality during the Intensive care Unit stay	from beginning of the preoxygenation period to discharged from intensive care unit (until day 28 for more)

Trial Locations

Locations (8)

Nantes university hospital, hôtel Dieu, Anesthesia intensive care unit; 🇫🇷 Nantes, France

Brest hospital, CHU La cavale Blanche, medical intensive care unit; 🇫🇷 Brest, France

CHD LES OUDOUAIRIES Service de réanimation polyvalente; 🇫🇷 La Roche Sur Yon, France

Ch Le Mans; 🇫🇷 Le Mans, France

Nantes University Hospital, Hôtel Dieu, Medical intensive care unit; 🇫🇷 Nantes, France

Rennes university hospital, Hôpital Pontchaillou, medical intensive care unit; 🇫🇷 Rennes, France

Nantes University hospital, Hôpital Laennec, pneumology intensive care unit; 🇫🇷 St Herblain, France

Tours university hospital, hôpital Bretonneau, medical intensive care unit; 🇫🇷 Tours, France