Benefits of Optiflow® Device for Preoxygenation Before Intubation in Acute Hypoxemic Respiratory Failure : The PREOXYFLOW Study
PREOXYFLOW
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
1 other identifier
interventional
122
1 country
6
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2012
Shorter than P25 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 4, 2012
CompletedFirst Posted
Study publicly available on registry
December 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedDecember 10, 2013
December 1, 2013
8 months
December 4, 2012
December 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
to determine whether Optiflow® used during the preoxygenation period before orotracheal intubation after crash induction is more efficient than standard face mask.
This outcome will be assessed from the beginning of the preoxygenation period to the end of orotracheal intubation by monitoring the pulse oxymetry
4 minutes
Secondary Outcomes (4)
Improvement of quality of preoxygenation
4 minutes
Reduction in side effects incidence related to intubation
1 hour
Reduction in Organ failure in the 5th day
at day 5
Reduction in morbi-mortality during the Intensive Care Unit stay.
until day 28 OR, if patient still in the intensive care unit (ICU) at Day 28, until discharge of ICU
Study Arms (2)
PREOXYFLOW
EXPERIMENTALPatients randomized in "PREOXYFLOW" group will received a four minutes preoxygenation period with Nasal High Flow Therapy (HFT) Optiflow ® (60 l/mn FIO2 = 1) before orotracheal intubation under laryngoscopy after crash induction
STANDARD FACE MASK
ACTIVE COMPARATORPatients 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. No specific trademark is requested by the protocol.
Interventions
Patients randomized in "PREOXYFLOW" group will received a four minutes preoxygenation period with Nasal High Flow Therapy (HFT) Optiflow ® (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 a standard face mask (15 l/mn) before orotracheal intubation under laryngoscopy after crash induction. Each hospital involved in this study will use the standard face mask as per its usual practice (no specific trademark requested by this protocol)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Protected adult
- Pregnancy
- Lack of consent
- Patient already enrolled in an other randomized study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Nantes Universitary Hospital, medical intensive care unit
Nantes, Loire Atlantique, 44093, France
Angers Universitary Hospital
Angers, 49933, France
Brest Universitary Hospital
Brest, 29609, France
La Roche/Yon Hospital
La Roche/Yon, 85925, France
Montpellier University hospital
Montpellier, 34295, France
Nantes Universitary Hospital, surgical intensive care unit
Nantes, 44093, France
Related Publications (1)
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.
PMID: 25869405DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2012
First Posted
December 11, 2012
Study Start
November 1, 2012
Primary Completion
July 1, 2013
Study Completion
August 1, 2013
Last Updated
December 10, 2013
Record last verified: 2013-12