Clinical trial NCT02700321: Benefits of High Flow Nasal Cannula Oxygen for Preoxygenation During Intubation in Non Severely Hypoxemic Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Need for Intubation, No Severe Hypoxemia
Keywords: non severely hypoxemic respiratory failure
preoxygenation
crash induction
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2016-03-07
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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
* Patient already enrolled in another study that could interfere with the primary objective of this study

Primary outcomes:
measure: lowest pulse oxymetry (SpO2) during intubation
timeFrame: 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
Secondary outcomes:
measure: Pulse oximetry
timeFrame: from the beginning of preoxygenation period to the end of intubation procedure. Usual duration is inferior to 15 minutes
measure: number of desaturation events (under 80%)
timeFrame: 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)
measure: Reduction in morbi-mortality during the Intensive care Unit stay
timeFrame: from beginning of the preoxygenation period to discharged from intensive care unit (until day 28 for more)
measure: SOFA score
timeFrame: Each day during the 5 first days after randomisation
Other outcomes:
Locations:
city: Brest
country: France
facility: Brest hospital, CHU La cavale Blanche, medical intensive care unit
city: La Roche Sur Yon
country: France
facility: CHD LES OUDOUAIRIES Service de réanimation polyvalente
city: Le Mans
country: France
facility: Ch Le Mans
city: Nantes
country: France
facility: Nantes university hospital, hôtel Dieu, Anesthesia intensive care unit
city: Nantes
country: France
facility: Nantes University Hospital, Hôtel Dieu, Medical intensive care unit
city: Rennes
country: France
facility: Rennes university hospital, Hôpital Pontchaillou, medical intensive care unit
city: St Herblain
country: France
facility: Nantes University hospital, Hôpital Laennec, pneumology intensive care unit
city: Tours
country: France
facility: Tours university hospital, hôpital Bretonneau, medical intensive care unit
Study officials:
affiliation: Nantes University Hospital
name: Olivier ZAMBON, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guitton C, Ehrmann S, Volteau C, Colin G, Maamar A, Jean-Michel V, Mahe PJ, Landais M, Brule N, Bretonniere C, Zambon O, Vourc'h M. Nasal high-flow preoxygenation for endotracheal intubation in the critically ill patient: a randomized clinical trial. Intensive Care Med. 2019 Apr;45(4):447-458. doi: 10.1007/s00134-019-05529-w. Epub 2019 Jan 21.