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Benefits of Optiflow® Device for Preoxygenation Before Intubation in Acute Hypoxemic Respiratory Failure : The PREOXYFLOW Study (PREOXYFLOW)

Primary Purpose

Acute Hypoxemic Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PREOXYFLOW
STANDARD FACE MASK
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Hypoxemic Respiratory Failure focused on measuring Acute hypoxemic respiratory failure, Preoxygenation, Crash induction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nantes Universitary Hospital, medical intensive care unit
  • Angers Universitary Hospital
  • Brest Universitary Hospital
  • La Roche/Yon Hospital
  • Montpellier University hospital
  • Nantes Universitary Hospital, surgical intensive care unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PREOXYFLOW

STANDARD FACE MASK

Arm Description

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. No specific trademark is requested by the protocol.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Improvement of quality of preoxygenation
Reduction in side effects incidence related to intubation
Reduction in Organ failure in the 5th day
Reduction in morbi-mortality during the Intensive Care Unit stay.

Full Information

First Posted
December 4, 2012
Last Updated
December 9, 2013
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01747109
Brief Title
Benefits of Optiflow® Device for Preoxygenation Before Intubation in Acute Hypoxemic Respiratory Failure : The PREOXYFLOW Study
Acronym
PREOXYFLOW
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

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Hypoxemic Respiratory Failure
Keywords
Acute hypoxemic respiratory failure, Preoxygenation, Crash induction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PREOXYFLOW
Arm Type
Experimental
Arm Description
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
Arm Title
STANDARD FACE MASK
Arm Type
Active Comparator
Arm Description
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. No specific trademark is requested by the protocol.
Intervention Type
Device
Intervention Name(s)
PREOXYFLOW
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
STANDARD FACE MASK
Intervention Description
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)
Primary Outcome Measure Information:
Title
to determine whether Optiflow® used during the preoxygenation period before orotracheal intubation after crash induction is more efficient than standard face mask.
Description
This outcome will be assessed from the beginning of the preoxygenation period to the end of orotracheal intubation by monitoring the pulse oxymetry
Time Frame
4 minutes
Secondary Outcome Measure Information:
Title
Improvement of quality of preoxygenation
Time Frame
4 minutes
Title
Reduction in side effects incidence related to intubation
Time Frame
1 hour
Title
Reduction in Organ failure in the 5th day
Time Frame
at day 5
Title
Reduction in morbi-mortality during the Intensive Care Unit stay.
Time Frame
until day 28 OR, if patient still in the intensive care unit (ICU) at Day 28, until discharge of ICU

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Nantes Universitary Hospital, medical intensive care unit
City
Nantes
State/Province
Loire Atlantique
ZIP/Postal Code
44093
Country
France
Facility Name
Angers Universitary Hospital
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Brest Universitary Hospital
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
La Roche/Yon Hospital
City
La Roche/Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Montpellier University hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Nantes Universitary Hospital, surgical intensive care unit
City
Nantes
ZIP/Postal Code
44093
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
25869405
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.
Results Reference
derived

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Benefits of Optiflow® Device for Preoxygenation Before Intubation in Acute Hypoxemic Respiratory Failure : The PREOXYFLOW Study

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