respiratory insufficiency
Conditions
Interventions
Patients randomized to the restricted PEEP-arm are ventilated with the lowest
possible PEEP level (0-5 cm H2O)
patients randomized to the liberal PEEP-arm
are ventilated with the currently practiced PEEP level (8 cm H2O). Patients
will be randomly assigned in a 1:1 ratio the restricted PEEP-arm of the libera
intensive care
mechanical ventilation
positive end-expiratory pressure
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 64 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 * Patient previously randomized in this RCT * Patient participating in another RCT with the same endpoint or interventions possibly compromising this study outcome * Patients with ongoing cardiac ischemia due to cardiac infarction and failed revascularization, patients with increased and uncontrollable intracranial pressure (of * 18 mmHg), patients with necrotizing fasciitis, and severe untreatable anemia such as in case of Jehovah*s Witnesses (as these patients can be considered to be vulnerable to the potentially dangerous hypoxemia which could develop more often, even for a short time, in the *restricted PEEP**arm of this trial) * Patient with a clinical diagnosis of ARDS or possible ARDS with a PaO2/ FiO2 40) * Patients with GOLD classification III or IV chronic obstructive pulmonary disease (COPD) * 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 * 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 * 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters include: * ICU length of stay (LOS), Hospital LOS * ICU mortality, Hospital mortality, 90-day mortality * Incidence of development ARDS * Incidence of severe hypoxemia * Incidence of severe atelectasis * Rescue therapies for severe hypoxemia: recruitment maneuver, prone position * Rescue therapies for severe atelectasis: bronchoscopy * Incidence of hemodynamic compromise * Incidence of pneumothorax * Incidence of pneumonia * Days with use of hemodynamic support * Days with use of sedation | — |
Countries
The Netherlands
Outcome results
None listed