Preoxygenation for Difficult Airway Management (PREOPTI-DAM)

Nantes University Hospital (NUH)

Status: Completed

Conditions: Intubation;Difficult

Treatments: Device: Preoxygenation by standard Facial mask; Device: Preoxygenation with high flow therapy by nasal cannula

Study type: Interventional

Funder types: Other

Identifiers

NCT03604120

RC17_0474

Details and patient eligibility

About

Tracheal intubation in operating room for patients at risk of difficult intubation remains a critical event. The aim of this study is to determine whether Nasal High Flow Therapy by nasal cannula Optiflow® administered before and during intubation is more efficient than the standard care for pre-oxygenation and oxygenation during anticipated difficult intubation

Full description

This study will be designed as followed: Patients will be randomized in 2 groups:

• Preoxygenation during 4 minutes with High Flow Nasal Cannula (60l/min FiO2 = 1) before and during intubation. The device will be maintained in place throughout the intubation procedure (including fiber-optic or laryngoscopic) in order to achieve oxygenation.
• Or Standard Preoxygenation during 4 minutes with FIBROXY® (Fiber-optic intubation) or standard facial mask (Laryngoscopic intubation), at FiO2=100%. FIBROXY mask will be maintained in place during the fiberoptic procedure. Standard facial mask, will be removed after the crash induction.

Enrollment: 186 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients 18 years of aged and over
• And anticipated difficult intubation
• And requiring a rapid sequence induction for laryngoscopic intubation
• Or requiring a fiberoptic intubation

Exclusion criteria

• BMI > 35
• Pulse oxymetry < 90% in ambient air
• Haemodynamic instability
• Pregnancy
• Protected adult
• Lack of consent
• Patient already enrolled in another randomized study looking forward improving preoxygenation quality.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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186 participants in 2 patient groups

Preoxygenation with high flow therapy by nasal cannula

Experimental group

Description:

High flow oxygen therapy by nasal cannula.

Treatment:

Device: Preoxygenation with high flow therapy by nasal cannula

Preoxygenation by standard Facial mask

Active Comparator group

Description:

Patients randomized in "STANDARD FACIAL MASK" group will receive a four minutes preoxygenation period with a standard face mask (15 l/mn) before orotracheal intubation under laryngoscopy after crash induction or Fiber-optic intubation under spontaneous ventilation.

Treatment:

Device: Preoxygenation by standard Facial mask