respiratory insufficiency
Conditions
Interventions
Patients randomized to the automated closed-loop ventilation-arm are ventilated
with INTELLiVENT-ASV mode
patients randomized to the conventional
ventilation-arm are ventilated with a non-automated mode of ventilation.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Admission to an ICU participating in this trial - Need for invasive ventilation - An expected duration of ventilation > 24 hours
Exclusion criteria
Exclusion criteria: - Age less than 18 years - Invasive ventilation longer than 1 hour in the intensive care unit before randomization - Invasive ventilation longer than 6 hours directly preceding intensive care unit admission - Patients who have recently undergone a pneumectomy or lobectomy - Patients with suspected or confirmed pregnancy - Patients with morbid obesity (body mass index > 40) - Patients with premorbid restrictive pulmonary disease (evidence of chronic interstitial infiltration on chest radiographs) - Patients in whom pulse oximetry is known to be unreliable (e.g., patients with carbon monoxide poisoning) - Patients with any neurologic diagnosis that can prolong duration of mechanical ventilation (e.g., patients with Guillain-Barré syndrome, high spinal cord lesion or amyotrophic lateral sclerosis, multiple sclerosis, or myasthenia gravis) - Patients receiving veno-venous, veno-arterial or arterio-venous extracorporeal membrane oxygenation (ECMO) - Previous randomization in this randomized controlled trial - Patients participating in another study with the same endpoint or interventions possibly comprising this study outcome - No informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the number of ventilator-free days and alive at day 28 after ICU admission. The co-primary endpoint is the quality of breathing, defined as time spent within predefined zones of optimal ventilation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters include: - ICU length of stay - Hospital length of stay - 28-day mortality - 90-day mortality - Incidence of ICU mortality - Incidence of hospital mortality - Incidence of: development of Acute Respiratory Distress Syndrome (ARDS), pneumonia, severe atelectasis, pneumothorax, respiratory muscle weakness, severe hypoxemia and severe hypercapnia - Incidence of use of rescue therapies for severe hypoxemia or severe atelectasis (e.g. recruitment maneuver, prone positioning, bronchoscopy for opening atelectasis) - Quality of life at day 28 | — |
Countries
Netherlands
Outcome results
None listed