Effect of Automated Closed-loop Ventilation versus Conventional Ventilation on Duration and Quality of Ventilation (*ACTiVE*) -a randomized clinical trial in intensive care unit patients

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 1040

Inclusion Criteria

- Admission to an ICU participating in this trial
- Need for invasive ventilation
- An expected duration of ventilation > 24 hours

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the number of ventilator-free days and alive at day 28<br /><br>after ICU admission. The co-primary endpoint is the quality of breathing,<br /><br>defined as time spent within predefined zones of optimal ventilation. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters include:<br /><br>- ICU length of stay<br /><br>- Hospital length of stay<br /><br>- 28-day mortality<br /><br>- 90-day mortality<br /><br>- Incidence of ICU mortality<br /><br>- Incidence of hospital mortality<br /><br>- Incidence of: development of Acute Respiratory Distress Syndrome (ARDS),<br /><br>pneumonia, severe atelectasis, pneumothorax, respiratory muscle weakness,<br /><br>severe hypoxemia and severe hypercapnia<br /><br>- Incidence of use of rescue therapies for severe hypoxemia or severe<br /><br>atelectasis (e.g. recruitment maneuver, prone positioning, bronchoscopy for<br /><br>opening atelectasis)<br /><br>- Quality of life at day 28</p><br>