Intellivent Versus Conventional Ventilation
Condition: Respiratory Failure; Self Efficacy
MeSH terms: Respiratory Insufficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      Partial automation of mechanical ventilation in resuscitation has been available for several
      years. New modalities are being developed to completely automate ventilation and oxygenation
      parameters (IntelliVent®.

      This pilot study compares over a 48h period the safety and efficacy of IntelliVent®, versus a
      conventional ventilation modality.
    

Detailed description: 
      Rational: Partial automation of mechanical ventilation in resuscitation has been available
      for several years. It can deliver a continuous ventilation adapted in real time to the
      patient's clinical condition,and decrease care workload and ventilation weaning duration. New
      modalities are being developed to completely automate ventilation and oxygenation parameters
      (IntelliVent®) and preliminary studies show that over short periods (2 to 4 h) such a system
      can ventilate patients more optimally and more safely, with a better ventilation efficiency
      (comparable effect on gas exchanges for a less "aggressive" ventilation). This pilot study
      compares over a longer period (48 hours), the safety and efficacy of IntelliVent®, versus a
      usual ventilation modality.

      Type of study: Monocenter, comparative, prospective, randomized, parallel study.

      Objective: To assess IntelliVent® safety, efficacy, and care workload.

      Assessment criteria:

        -  Safety is assessed by measuring the number of times it is necessary to manually
           intervene on the ventilator settings because for one the following parameters: A range
           SpO2, EtCO2, plateau pressure (Pplat), tidal volume (VT), respiratory rate (RR),values
           considered as non-optimal, as defined a priori and consensually by a panel of experts.

        -  Efficacy, in terms of ventilation, is assessed by the time spent within a range EtCO2
           and Pplat and VT and RR values considered as optimal, as defined a priori and
           consensually by a panel of experts.

      Efficacy, in terms of oxygenation, is assessed by the time spent within a range SpO2 values
      considered as optimal, as defined a priori and consensually by a panel of experts.

      - Care workload is assessed by the number of ventilator setting adjustments by nursing staff
      in each group.

      Number of subjects: 80 patients receiving invasive mechanical ventilation for acute
      respiratory failure.

      Methods: The selected patients presenting with inclusion criteria are ventilated either with
      IntelliVent® or with the unit's usual ventilation following a random selection.
    

Intervention name(s): Intellivent; automatic mode implemented on a S1 ventilator
Intervention type(s): Device
Intervention description(s): Intellivent allows an automatic adjustment of the following parameters: FiO2, PEEP and %VM according to adjusted parameters: Size, SpO2 and EtCO2
Other intervention name(s): Closed-loop ventilation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: automation; closed loop; oxygenation; ventilation