Advisory Lead ARDS Respirator Management
Condition: ARDS, Human
MeSH terms: Respiratory Distress Syndrome
Study type: Observational

Summary: 
      A advisory will be activated in the ICUs patient data management system. The trial will be
      conducted as observational cohort trial. During the first six month all patients with a LIPS
      ≥ 4 will be included in the control group. No change of care is needed. In a second phase
      during the next six months, all patients with a LIPS ≥ 4 will be included into the advisory
      group where advisories will be shown in the patient data management system.

      To create this advisory, a clinical advisory rule is executed every 4 hours and the
      appropriate advisory text is calculated. If the defined threshold values (driving pressure ≥
      15mbar) are reached, then the advisory displays a recommendation to rethink the patient's
      ventilation strategy. Furthermore, permissive hypercapnia and oxygen saturating limits
      considered as safe will be given. (paCO2: 55mmHg, pH: 7.25, paO2: 80 mmHg, SaO2: 92%)
    

Detailed description: 
      Background Lung protective ventilation is a well-established treatment to reduce
      ventilator-induced lung injury (VILI) in patients suffering from ARDS. To quantify lung
      protective ventilation the concept of driving pressure (ΔP) and mechanical power were
      postulated.

      Although low tidal volumes and low driving pressures are considered standard of care, it was
      shown that lung protective ventilation is very little used in ICU patients. Especially in
      those with a less severe lung disease.

      Automated Clinical Decision Support (CDS) systems are gaining more attention in clinical
      practice. They have been successfully used to increase medical provider adherence to
      guidelines or local department policy. Another successful means of influencing behavior of
      medical providers are so called nudge-based interventions. Currently there is little evidence
      on nudge-type interventions or automated alerts for ventilator settings in the ICU. To our
      knowledge studies that linked these interventions to a change in patient's outcome are
      lacking.

      Hypothesis Activation of an advisory in the patient data management system accompanied by
      educational sessions and feedback emails decrease ventilation driving pressure in
      mechanically ventilated patients at increased risk of ARDS (LIPS ≥ 4). As secondary outcome
      parameters, incidence of ARDS, ventilator free days, reintubation rate, length of stay in the
      ICU or the hospital and mortality at day 28 will be evaluated.

      Methods As an advisory is activated in the ICU software, medical staff caring for the
      patients can't be blinded. Therefore, the trial will be conducted as observational cohort
      trial. During the first six month all patients with a LIPS ≥ 4 will be included in the
      control group. No change of care is needed. In a second phase during the next six months, all
      patients with a LIPS ≥ 4 will be included into the alert group where advisories will be shown
      in the patient data management system.

      To create this advisory, a clinical advisory rule is executed every 4 hours and the
      appropriate advisory text is calculated. If the defined threshold values (driving pressure ≥
      15mbar) are reached, then the advisory displays a recommendation to rethink the patient's
      ventilation strategy. Furthermore, permissive hypercapnia and oxygen saturating limits
      considered as safe will be given. (paCO2: 55mmHg, pH: 7.25, paO2: 80 mmHg, SaO2: 92%)

      Outcome The primary outcome is an improvement of medical stuff's adherence to current
      recommendations shown by a reduction of the mean ventilator driving pressure (by using the
      AUC of driving pressures).

      The secondary outcomes are ventilator free days, 28-day mortality, reintubation rate,
      incidence of ARDS and length of stay in the ICU and the hospital.
    

Intervention name(s): Activation of Advisory
Intervention type(s): Device
Intervention description(s): Advisory is activated which will show if driving pressure is greater or equal 15
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients at risk of ARDS at six intensive care units will be included in this trial. Study
        population will consist of medical and surgical ICU patients.