Comparing automated and conventional ventilation methods in ICU patients
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
This study is testing if a new automated breathing support system can help critically ill patients in the ICU breathe better and need less time on a ventilator compared to traditional methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 10 sites (Genua and 9 other locations) |
| Trial ID | NCT04593810 on ClinicalTrials.gov |
What this trial studies
This international, multicenter trial aims to evaluate the effectiveness of INTELLiVENT-Adaptive Support Ventilation (ASV) compared to conventional ventilation in critically ill patients requiring invasive mechanical ventilation. The primary goal is to determine if INTELLiVENT-ASV can reduce the duration of ventilation needed, while a secondary aim is to assess its impact on the quality of breathing within the first 24 hours of ventilation. Patients will be randomly assigned to either ventilation method shortly after intubation, with a target enrollment of 1,200 participants across multiple ICUs in the Netherlands and Italy.
Who should consider this trial
Good fit: Ideal candidates are adult ICU patients who are intubated and expected to require invasive ventilation for at least 24 hours.
Not a fit: Patients who have recently undergone lung surgery or have certain neurological conditions that prolong ventilation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to shorter ventilation times and improved breathing quality for critically ill patients.
How similar studies have performed: While the approach of using automated ventilation is promising, evidence for its clinical benefit compared to conventional methods is still lacking, making this study a potentially novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * admission to one of the participating ICUs * intubated and receiving invasive ventilation * anticipated duration of ventilation of at least 24 hours Exclusion Criteria: * age below 18 years * patients with suspected or confirmed pregnancy * invasive ventilation \> 1 hour in the ICU * invasive ventilation \> 6 hours directly preceding the current ICU admission * participation in another interventional trial using similar endpoints * after recent pneumectomy or lobectomy * morbid obesity (body mass index \> 40 kg/m2) * premorbid restrictive pulmonary disease * unreliable pulse oximetry (secondary to carbon monoxide poisoning or sickle cell disease) * 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 * patients receiving or planned to receive veno-venous, veno-arterial or arterio-venous extracorporeal membrane oxygenation (ECMO) * unavailability of INTELLiVENT-ASV (no ventilator available with this ventilation mode) * previously randomized in this study * no informed consent
Where this trial is running
Genua and 9 other locations
- Ospedale Policlinico San Martino — Genua, Italy (Not_yet_recruiting)
- Policlinico San Matteo Fondazione IRCCS — Pavia, Italy (Not_yet_recruiting)
- Flevoziekenhuis — Almere, Netherlands (Not_yet_recruiting)
- Academic Medical Center, Intensive Care — Amsterdam, Netherlands (Recruiting)
- Reinier de Graaf Gasthuis — Delft, Netherlands (Recruiting)
- Catharina Ziekenhuis — Eindhoven, Netherlands (Not_yet_recruiting)
- Leiden UMC — Leiden, Netherlands (Not_yet_recruiting)
- Canisius-Wilhelmina Hospital — Nijmegen, Netherlands (Not_yet_recruiting)
- Elisabeth-TweeSteden Ziekenhuis — Tilburg, Netherlands (Not_yet_recruiting)
- Diakonessenhuis, Utrecht — Utrecht, Netherlands (Not_yet_recruiting)
Study contacts
- Principal investigator: Janneke Horn, MD, PhD — Department of Intensive Care, Academic Medical Center
- Study coordinator: Michela Botta, MD
- Email: m.botta@amsterdamumc.nl
- Phone: +31626198315
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.