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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01747109
First received: December 4, 2012
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention
Acute Hypoxemic Respiratory Failure
Device: PREOXYFLOW
Procedure: STANDARD FACE MASK

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

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. [ Time Frame: 4 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4 minutes ] [ Designated as safety issue: No ]
  • Reduction in side effects incidence related to intubation [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
  • Reduction in Organ failure in the 5th day [ Time Frame: at day 5 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 122
Study Start Date: November 2012
Study Completion Date: August 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PREOXYFLOW
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
Device: PREOXYFLOW
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
Active Comparator: STANDARD FACE MASK
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.
Procedure: STANDARD FACE MASK
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)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01747109

Locations
France
Nantes Universitary Hospital, medical intensive care unit
Nantes, Loire Atlantique, France, 44093
Angers Universitary Hospital
Angers, France, 49933
Brest Universitary Hospital
Brest, France, 29609
La Roche/Yon Hospital
La Roche/Yon, France, 85925
Montpellier University hospital
Montpellier, France, 34295
Nantes Universitary Hospital, surgical intensive care unit
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01747109     History of Changes
Other Study ID Numbers: RC12_0178
Study First Received: December 4, 2012
Last Updated: December 9, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Nantes University Hospital:
Acute hypoxemic respiratory failure
Preoxygenation
Crash induction

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 20, 2014