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Which Place for High Flow Oxygen in ICU ?

Primary Purpose

Hypoxemia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Optiflow
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypoxemia focused on measuring hypoxemia, high flow oxygen therapy, respiratory failure

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: patients with respiratory failure.

  • Spontaneously breathing patient requiring administration at least 40% oxygen, or,
  • Patient under mechanical ventilation, during respiratory weaning.

Exclusion Criteria:

  • Facial trauma, active hemoptysis, pneumothorax, thoraco-abdominal surgery or upcoming intubation for spontaneously breathing patients.
  • Neuromuscular disease, altered consciousness or agitation for patients under mechanical ventilation.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    High Flow Oxygen

    Conventionnal

    Arm Description

    Patients receiving oxygen via high flow oxygen therapy (Optiflow)

    patients receiving oxygen via conventional way (low flow)

    Outcomes

    Primary Outcome Measures

    Change from baseline in Oxygenation criteria
    Arterial oxygen partial pressure (PO2), oxygen saturation by pulse oximetry (SpO2), arterial PO2/FiO2, positive end expiratory pressure (PEEP)

    Secondary Outcome Measures

    Change from baseline in Ventilation criteria
    respiratory rate (RR), arterial partial CO2 pressure (PCO2), pH, sterno-mastoid EMG

    Full Information

    First Posted
    January 9, 2014
    Last Updated
    January 29, 2016
    Sponsor
    Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02080208
    Brief Title
    Which Place for High Flow Oxygen in ICU ?
    Official Title
    Which Place for High Flow Oxygen in Intensive Care Unit ?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2011 (undefined)
    Primary Completion Date
    June 2013 (Actual)
    Study Completion Date
    June 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Patients with respiratory failure often need oxygen and/or ventilatory support. Patients who need only oxygen support, usually received low flow oxygen (< 15 Liters / min), as well as in respiratory weaning. Now new devices can be used. They provide high flow oxygen with different benefits. This high flow devices provide exact fraction of inspired oxygen (FiO2), allows a positive end expiratory pressure and supplies a wash out flow. The hypothesis of this study is that the high flow oxygen enable more efficient oxygen administration than conventional oxygen. In addition, it would improve the effectiveness of the ventilation of the patient, through flushing the dead space.
    Detailed Description
    The investigators hypothesized that when using high flow oxygen therapy, respiratory failure is relieved, as well as ventilation failure, so accessories are less stressed muscles, and this can be demonstrated by the electromyography (EMG) of sterno-mastoid..

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypoxemia
    Keywords
    hypoxemia, high flow oxygen therapy, respiratory failure

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    High Flow Oxygen
    Arm Type
    Experimental
    Arm Description
    Patients receiving oxygen via high flow oxygen therapy (Optiflow)
    Arm Title
    Conventionnal
    Arm Type
    No Intervention
    Arm Description
    patients receiving oxygen via conventional way (low flow)
    Intervention Type
    Device
    Intervention Name(s)
    Optiflow
    Intervention Description
    patients receive oxygen via high flow oxygen therapy during 20 minutes
    Primary Outcome Measure Information:
    Title
    Change from baseline in Oxygenation criteria
    Description
    Arterial oxygen partial pressure (PO2), oxygen saturation by pulse oximetry (SpO2), arterial PO2/FiO2, positive end expiratory pressure (PEEP)
    Time Frame
    20 minutes
    Secondary Outcome Measure Information:
    Title
    Change from baseline in Ventilation criteria
    Description
    respiratory rate (RR), arterial partial CO2 pressure (PCO2), pH, sterno-mastoid EMG
    Time Frame
    20 minutes
    Other Pre-specified Outcome Measures:
    Title
    change from baseline in hemodynamic criteria
    Description
    cardiac frequency, arterial blood pressure
    Time Frame
    20 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with respiratory failure. Spontaneously breathing patient requiring administration at least 40% oxygen, or, Patient under mechanical ventilation, during respiratory weaning. Exclusion Criteria: Facial trauma, active hemoptysis, pneumothorax, thoraco-abdominal surgery or upcoming intubation for spontaneously breathing patients. Neuromuscular disease, altered consciousness or agitation for patients under mechanical ventilation.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Emilie Bialais, PhD Student
    Organizational Affiliation
    Cliniques universitaires Saint-Luc
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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