respiratory failure acute breathing failure
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a patient must meet the following criteria:admission to one of the participating ICUs;intubated and receiving invasive ventilation with an expected duration of ventilation of at least 24 hours.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria are excluded from participation:age below 18 years;receiving invasive ventilation > 1 hour in the ICU, or receiving invasive ventilation > 6 hours directly preceding the current ICU admission (i.e., in the operating room or in the emergency department);receiving or planned to receive veno–venous, veno–arterial or arterio–venous extracorporeal membrane oxygenation (ECMO);having COPD GOLD III and IV;contra–indication for hypercapnia, such as ongoing cardiac ischemia (as defined in the guideline of the European Society of Cardiology), or having suspected or confirmed increased intracranial pressure due to brain injury, judged by the attending physician;any neurologic diagnosis that can prolong duration of mechanical ventilation, e.g., Guillain–Barré syndrome, high spinal cord lesion or amyotrophic lateral sclerosis, multiple sclerosis, or myasthenia gravis;suspected or confirmed pregnancy;participation in another interventional trial using similar endpoints;previously randomized in this study;no informed consent; oradmitted for terminal care
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is feasibility, assessed by the difference in respiratory rate (RR) between the two groups, from the start of mechanical ventilation until first extubation. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints include protocol compliance and feasibility of collecting data. Another secondary endpoint is safety, assessed by the occurrence of unacceptable hypercapnia and hypoxemia and the incidence of ventilator–associated complications. | — |
Countries
Netherlands, Spain
Contacts
Reinier de Graaf