Effect of Automated Closed-Loop Ventilation Versus Conventional Ventilation on Duration and Quality of Ventilation

Launched by PROF. DR. MARCUS J. SCHULTZ · Oct 19, 2020

Keywords

ClinConnect Summary

The ACTiVE study is a clinical trial that aims to compare two types of ventilation for patients in the intensive care unit (ICU). One method is called INTELLiVENT-Adaptive Support Ventilation (ASV), which is a fully automated system that adjusts itself based on the patient's needs. The other method is conventional ventilation, which requires more manual adjustments by healthcare providers. The main goal of the study is to see if using INTELLiVENT-ASV can help patients spend less time on a ventilator and improve their breathing quality.

To participate in this trial, patients must be 18 years or older, admitted to one of the participating ICUs, and require invasive ventilation (a breathing tube) for at least 24 hours. Patients who have recently undergone certain surgeries, have certain medical conditions, or are pregnant are not eligible. Those who join the study will be randomly assigned to receive either the automated ventilation or the conventional method, and their progress will be carefully monitored. This trial will help determine if the new automated system is beneficial for patients needing respiratory support.

Gender

ALL

Eligibility 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