Clinical trial NCT01747109: Benefits of Optiflow® Device for Preoxygenation Before Intubation in Acute Hypoxemic Respiratory Failure : The PREOXYFLOW Study
Official title: A Prospective, Multicenter, Randomized, Controlled, Parallel-group, Open Label Trial Evaluating Benefits of Nasal High Flow Therapy (HFT) in Preoxygenation Before Tracheal Intubation in Acute Hypoxemic Respiratory Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Hypoxemic Respiratory Failure
Keywords: Acute hypoxemic respiratory failure
Preoxygenation
Crash induction
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2012-12-11
Enrollment: 122
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: Oro-tracheal intubation in intensive unit care(ICU) in acute hypoxemic respiratory failure after crash induction remains a critical event.

The aim of this study is to determine whether Nasal High Flow Therapy (HFT) Optiflow ® is more efficient than the face mask for preoxygenation before orotracheal intubation after crash induction in acute hypoxemic respiratory failure

Detailed description: This study will be designed as followed : Patients will be randomized in 2 groups :"PREOXYFLOW" or "STANDARD FACE MASK".

Patients randomized in "PREOXYFLOW" group will received a four minutes preoxygenation period with Nasal High Flow Therapy (HFT) (60 l/mn FIO2 = 1) before orotracheal intubation under laryngoscopy after crash induction. Patients randomized in "STANDARD FACE MASK" group will received a four minutes preoxygenation period with standard face mask (15 l/mn) before orotracheal intubation under laryngoscopy after crash induction

Eligibility criteria: Inclusion Criteria:

* Adults older than 18 years regardless of the gender
* Acute hypoxemic respiratory failure defined as :

Respiratory rate \> 30/mn AND Hypoxemia with SpO2 \<90% with oxygen supply \> FiO2 0,5 AND PaO2/FiO2 \<300 mmHg

Exclusion Criteria:

* Contraindication to oro-tracheal intubation
* Intubation without anesthetic delivery
* Intubation during cardiac arrest
* Asphyxia with immediate intubation needed
* Nasopharyngeal obstacle with contraindication to use Optiflow device
* Patients with a documented Cormack IV exposition before inclusion
* Protected adult
* Pregnancy
* Lack of consent
* Patient already enrolled in an other randomized study.

Primary outcomes:
measure: to determine whether Optiflow® used during the preoxygenation period before orotracheal intubation after crash induction is more efficient than standard face mask.
timeFrame: 4 minutes
Secondary outcomes:
measure: Improvement of quality of preoxygenation
timeFrame: 4 minutes
measure: Reduction in side effects incidence related to intubation
timeFrame: 1 hour
measure: Reduction in Organ failure in the 5th day
timeFrame: at day 5
measure: Reduction in morbi-mortality during the Intensive Care Unit stay.
timeFrame: until day 28 OR, if patient still in the intensive care unit (ICU) at Day 28, until discharge of ICU
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes Universitary Hospital, medical intensive care unit
state: Loire Atlantique
city: Angers
country: France
facility: Angers Universitary Hospital
city: Brest
country: France
facility: Brest Universitary Hospital
city: La Roche/Yon
country: France
facility: La Roche/Yon Hospital
city: Montpellier
country: France
facility: Montpellier University hospital
city: Nantes
country: France
facility: Nantes Universitary Hospital, surgical intensive care unit
Study officials:
References:
citation: Vourc'h M, Asfar P, Volteau C, Bachoumas K, Clavieras N, Egreteau PY, Asehnoune K, Mercat A, Reignier J, Jaber S, Prat G, Roquilly A, Brule N, Villers D, Bretonniere C, Guitton C. High-flow nasal cannula oxygen during endotracheal intubation in hypoxemic patients: a randomized controlled clinical trial. Intensive Care Med. 2015 Sep;41(9):1538-48. doi: 10.1007/s00134-015-3796-z. Epub 2015 Apr 14.