INTELLiVENT-ASV Using Mainstream Versus Sidestream End-Tidal CO2 Monitoring
Condition: Mechanical Ventilation Complication; Intensive Care Unit; Postoperative Care
Study type: Interventional

Summary: 
      Background

      INTELLiVENT-ASV, an automated closed-loop mode of mechanical ventilation, available on
      Hamilton ventilators for clinical use, uses mainstream end-tidal CO2 (etCO2) monitoring to
      adjust minute ventilation. However, sensors for mainstream etCO2 monitoring are expensive and
      fragile. The less expensive and more robust sensors for sidestream etCO2 monitoring could
      serve as a good alternative to sensors for mainstream etCO2 monitoring.

      Objective of the study

      The objective of this randomized noninferiority trial is to determine whether INTELLiVENT-
      ASV with sidestream capnography is noninferior to INTELLiVENT-ASV with mainstream capnography
      with regard to the percentage of breaths in a broadly accepted predefined 'optimal' zone of
      ventilation.

      Hypothesis

      The investigators hypothesize that INTELLiVENT-ASV with sidestream capnography is noninferior
      to INTELLiVENT-ASV with mainstream capnography with respect to the percentage of breaths a
      patient spends within the 'optimal' zone of ventilation.

      Study design

      INTELLiSTREAM is a randomized noninferiority study.

      Study population

      The study population consists of consecutive elective cardiac surgery patients who are
      expected to need at least 2 hours of postoperative ventilation in the ICU of Amsterdam
      Medical University Centers, location 'AMC'.

      Intervention

      Shortly after arrival at the ICU, patients will be randomized to receive either ventilation
      with INTELLiVENT-ASV with mainstream capnography or sidestream capnography.

      Primary outcome of the study

      The primary study endpoint is the percentage of breaths a patient spends inside the 'optimal'
      zone of ventilation, as defined before (i.e. tidal volume < 10 ml/kg PBW, maximum airway
      pressure < 30cm H2O, etCO2 between 30-46 mmHg and pulse oximetry between 93-98%).

      Secondary outcomes

      The percentage of time spent in other ventilation zones, as defined in the protocol. Time to
      spontaneous breathing, duration of weaning, loss of etCO2 signal, duration of postoperative
      ventilation and ventilator parameters as well as results of clinically indicated arterial
      blood gas analysis.

      Nature and extent of burden and risks associated with participation, benefit and group
      relatedness Hamilton ventilators can use mainstream and sidestream etCO2 sensors.
      INTELLiVENT-ASV is a safe mode of ventilation, also in patients who receive postoperative
      ventilation. Furthermore, as all patients are sedated as part of standard care during
      postoperative ventilation, the burden for the patient is minimal
    


Intervention name(s): Sidestream capnography using the 'Respironics LoFlo Sidestream CO2 Module'; Mainstream capnography using the 'Respironics Capnostat 5 Mainstream CO2 sensor'
Intervention type(s): Device; Device
Intervention description(s): Study patients randomized into the 'Sidestream capnography' arm will receive postoperative ventilation on the ICU with INTELLiVENT-ASV with sidestream etCO2 monitoring using the 'Respironics LoFlo Sidestream CO2 Module'.; Study patients randomized into the 'Mainstream capnography' arm will receive postoperative ventilation on the ICU with INTELLiVENT-ASV with mainstream etCO2 monitoring using the 'Respironics Capnostat 5 Mainstream CO2 sensor'.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: INTELLiSTREAM is a single-center randomized clinical noninferiority trial
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Mechanical Ventilation; INTELLiVENT-ASV; Quality of Breath; Elective Cardiac Surgery; Postoperative Pulmonary Complications; Lung Protective ventilation; Mainstream Capnography; Sidestream Capnography; Noninferiority trial; Closed Loop Ventilation; Intensive Care Unit; Automated Mechanical ventilation