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Completed

NCT Number: NCT01747109

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

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

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Key information

Conditions

Acute Hypoxemic Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nantes Universitary Hospital, medical intensive care unit, Nantes, Loire Atlantique, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PREOXYFLOW

Device

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

STANDARD Face Mask

Procedure

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 outcomes

  1. to determine whether Optiflow® used during the preoxygenation period before orotracheal intubation after crash induction is more efficient than standard face mask.

    Time frame: 4 minutes

    This outcome will be assessed from the beginning of the preoxygenation period to the end of orotracheal intubation by monitoring the pulse oxymetry

Secondary outcomes

  1. Improvement of quality of preoxygenation

    Time frame: 4 minutes

  2. Reduction in side effects incidence related to intubation

    Time frame: 1 hour

  3. Reduction in Organ failure in the 5th day

    Time frame: at day 5

  4. 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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study 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

Acronym: PREOXYFLOW

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 11, 2012
Registry last updated
Dec 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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