A Prospective , Multicenter , Randomized, Controlled, Parallel-group , Open-label Trial Evaluating Benefits of High Flow Nasal Cannula (HFNC) Oxygen for Preoxygenation During Intubation in Non Severely Hypoxemic Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Need for Intubation, No Severe Hypoxemia
- Sponsor
- Nantes University Hospital
- Enrollment
- 192
- Locations
- 8
- Primary Endpoint
- lowest pulse oxymetry (SpO2) during intubation
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
lowest pulse oxymetry (SpO2) during intubation
Time Frame: 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 Outcomes
- 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))