Clinical Trial: ORI2 : ORI for hyperOxia Reduction in ICU

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: ORI2 : ORI for hyperOxia Reduction in ICU

Brief Summary:

The ORI (Reserve Oxygen Index) is an index measured through sensors SpO2 (oxygen saturation by pulse oximetry - Radical-7 MASIMO) that evaluates noninvasively PaO2 (partial pressure of oxygen). It represents the high PaO2 with values to 0 for a PaO2 <100 and up to 1 when the PaO2 rises above 200 mmHg. Monitoring by the ORI, with setting an alarm for low values (≥0,01) could help alert nurses when to decrease the FiO2 (inspired oxygen fraction). This could reduce the FiO2 and avoid hyperoxia (i.e. daily PaO 2> 80 mmHg or 100). In the literature, hyperoxia can be associated with prolonged mechanical ventilation, with increased risk of atelectasis, or with excess mortality. And the use of high FiO2 led to a "over-consumption" of oxygen and therefore to additional costs.

The purpose of this feasibility study is to evaluate the use of ORI can help to decrease length of moderate hypoxemia (PaO2>100mmHg) during mechanical ventilation and oxygenotherapy, in comparison with monitoring the SpO2 only.


Detailed Summary:
Sponsor: University Hospital, Angers

Current Primary Outcome: Number of mechanical ventilation day with PaO2 equal or above to 100 mmHg [ Time Frame: inclusion to the end of mechanical ventilation (or Day 28 if patient is still mechanically ventilated) ]

The secondary endpoint is the number (in day) of hypoxemia (defined by PaO2<60 mmHg - measured by blood gases obtained in usual practice). PaO2 will be followed by the inclusion until the end of mechanical ventilation or D28.


Original Primary Outcome: Average daily PaO2 [ Time Frame: inclusion to the end of mechanical ventilation (or Day 28 if patient is still mechanically ventilated) ]

The primary endpoint is the average daily PaO 2 in each group (measured by blood gases obtained in usual practice ) . PaO2 will be followed by the inclusion until the end of mechanical ventilation or D28.


Current Secondary Outcome:

  • Minimum and maximum daily FiO2 [ Time Frame: Inclusion to the end of oxygenotherapy (or Day 28 if patient is still under oxygenotherapy) ]
    The secondary endpoints are the minimum and maximum daily FiO2, obtained by respirator in each group. FiO2 will be followed by the inclusion until the end of oxygenotherapy or D28.
  • Minimum and maximum daily PaO2 [ Time Frame: Inclusion to the end of oxygenotherapy (or Day 28 if patient is still under oxygenotherapy) ]
    The secondary endpoints are the minimum and maximum daily PaO2, (measured by blood gases obtained in usual practice ) . PaO2 will be followed by the inclusion until the end of oxygenotherapy or D28.
  • Length of mechanical ventilation [ Time Frame: inclusion to the end of mechanical ventilation (or Day 28 if patient is still mechanically ventilated) ]
    The secondary endpoint is the length of mechanical ventilation, (unit: day number)
  • Number of day with PaO2 equal or above to 80 mmHg [ Time Frame: inclusion to the end of oxygenotherapy (or Day 28 if patient is still under oxygenotherapy) ]
    The secondary endpoint is the number of the day where patient is mechanically ventilated and has a PaO2 equal or above to 100 mmHg and 80 mmHg . PaO2 is measured by blood gases obtained in usual practice . this outcome will be followed by the inclusion until the end of mechanical ventilation or D28.
  • Number of hypoxemia episode [ Time Frame: inclusion to the end of oxygenotherapy (or Day 28 if patient is still under oxygenotherapy) ]
    The secondary endpoint is the number (in day) of hypoxemia (defined by PaO2<60 mmHg - measured by blood gases obtained in usual practice). PaO2 will be followed by the inclusion until the end of oxygenotherapy or D28.
  • Number of day without mechanical ventilation at D28 [ Time Frame: inclusion to D28 ]
    The secondary endpoint is the number of day without mechanical ventilation at D28. It will be followed by the inclusion until D28.
  • Number of atelectasis episodes requiring specific medical care (that means fibro-aspiration or posture of patient) [ Time Frame: inclusion to the end of mechanical ventilation (or Day 28 if patient is still mechanically ventilated) ]
    The secondary endpoint is the number of atelectasis episodes requiring specific medical care. It will be followed by the inclusion until the end of mechanical ventilation or D28.
  • Average daily PaO2 [ Time Frame: inclusion to the end of oxygenotherapy (or Day 28 if patient is still under oxygenotherapy) ]
    The primary endpoint is the average daily PaO 2 in each group (measured by blood gases obtained in usual practice ) . PaO2 will be followed by the inclusion until the end of oxygenotherapy or D28.


Original Secondary Outcome:

  • Minimum and maximum daily FiO2 [ Time Frame: Inclusion to the end of mechanical ventilation (or Day 28 if patient is still mechanically ventilated) ]
    The secondary endpoints are the minimum and maximum daily FiO2, obtained by respirator in each group. FiO2 will be followed by the inclusion until the end of mechanical ventilation or D28.
  • Minimum and maximum daily PaO2 [ Time Frame: Inclusion to the end of mechanical ventilation (or Day 28 if patient is still mechanically ventilated) ]
    The secondary endpoints are the minimum and maximum daily PaO2, (measured by blood gases obtained in usual practice ) . PaO2 will be followed by the inclusion until the end of mechanical ventilation or D28.
  • Length of mechanical ventilation [ Time Frame: inclusion to the end of mechanical ventilation (or Day 28 if patient is still mechanically ventilated) ]
    The secondary endpoint is the length of mechanical ventilation, (unit: day number)
  • Number of mechanical ventilation day with PaO2 equal or above to 100 mmHg and 80 mmHg [ Time Frame: inclusion to the end of mechanical ventilation (or Day 28 if patient is still mechanically ventilated) ]
    The secondary endpoint is the number of the day where patient is mechanically ventilated and has a PaO2 equal or above to 100 mmHg and 80 mmHg . PaO2 is measured by blood gases obtained in usual practice . this outcome will be followed by the inclusion until the end of mechanical ventilation or D28.
  • Number of hypoxemia episode [ Time Frame: inclusion to the end of mechanical ventilation (or Day 28 if patient is still mechanically ventilated) ]
    The secondary endpoint is the number (in day) of hypoxemia (defined by PaO2<60 mmHg - measured by blood gases obtained in usual practice). PaO2 will be followed by the inclusion until the end of mechanical ventilation or D28.
  • Number of day without mechanical ventilation at D28 [ Time Frame: inclusion to the end of mechanical ventilation (or Day 28 if patient is still mechanically ventilated) ]
    The secondary endpoint is the number of day without mechanical ventilation at D28. It will be followed by the inclusion until the end of mechanical ventilation or D28.
  • Number of atelectasis episodes requiring specific medical care (that means fibro-aspiration or posture of patient) [ Time Frame: inclusion to the end of mechanical ventilation (or Day 28 if patient is still mechanically ventilated) ]
    The secondary endpoint is the number of atelectasis episodes requiring specific medical care. It will be followed by the inclusion until the end of mechanical ventilation or D28.


Information By: University Hospital, Angers

Dates:
Date Received: August 22, 2016
Date Started: April 27, 2017
Date Completion: September 2017
Last Updated: April 28, 2017
Last Verified: November 2016