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

Nantes University Hospital (NUH)

Status: Completed

Conditions: Need for Intubation, No Severe Hypoxemia

Treatments: Device: OPTIFLOW/ AIRVO; Procedure: STANDARD Face Mask

Study type: Interventional

Funder types: Other

Identifiers

NCT02700321

RC15_0047

Details and patient eligibility

About

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

Full 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

Enrollment: 192 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

192 participants in 2 patient groups

High Flow nasal cannula oxygen (HFNC)

Experimental group

Description:

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.

Treatment:

Device: OPTIFLOW/ AIRVO

STANDARD high flow Face Mask (HFFM)

Active Comparator group

Description:

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.

Treatment:

Procedure: STANDARD Face Mask