Effect of Automated Closed-loop ventilation versus convenTional VEntilation on duration and quality of ventilation in critically ill patients (ACTiVE) – study protocol of a randomized clinical trial
Issued Date
2022-12-01
Resource Type
eISSN
17456215
Scopus ID
2-s2.0-85128801834
Pubmed ID
35461264
Journal Title
Trials
Volume
23
Issue
1
Rights Holder(s)
SCOPUS
Bibliographic Citation
Trials Vol.23 No.1 (2022)
Suggested Citation
Botta M., Tsonas A.M., Sinnige J.S., De Bie A.J.R., Bindels A.J.G.H., Ball L., Battaglini D., Brunetti I., Buiteman–Kruizinga L.A., van der Heiden P.L.J., de Jonge E., Mojoli F., Robba C., Schoe A., Paulus F., Pelosi P., Neto A.S., Horn J., Schultz M.J., Botta M., Horn J. Effect of Automated Closed-loop ventilation versus convenTional VEntilation on duration and quality of ventilation in critically ill patients (ACTiVE) – study protocol of a randomized clinical trial. Trials Vol.23 No.1 (2022). doi:10.1186/s13063-022-06286-w Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/85321
Title
Effect of Automated Closed-loop ventilation versus convenTional VEntilation on duration and quality of ventilation in critically ill patients (ACTiVE) – study protocol of a randomized clinical trial
Author's Affiliation
Amsterdam Neuroscience
IRCCS San Martino Polyclinic Hospital
Hogeschool van Amsterdam, University of Applied Sciences
Hamilton Medical AG
Catharina Ziekenhuis
Università degli Studi di Genova
Hospital Israelita Albert Einstein
Leids Universitair Medisch Centrum
Università degli Studi di Pavia
Faculty of Medicine, Nursing and Health Sciences
Mahidol University
Nuffield Department of Medicine
Universiteit van Amsterdam
Reinier de Graaf Hospital - SSDZ
IRCCS San Martino Polyclinic Hospital
Hogeschool van Amsterdam, University of Applied Sciences
Hamilton Medical AG
Catharina Ziekenhuis
Università degli Studi di Genova
Hospital Israelita Albert Einstein
Leids Universitair Medisch Centrum
Università degli Studi di Pavia
Faculty of Medicine, Nursing and Health Sciences
Mahidol University
Nuffield Department of Medicine
Universiteit van Amsterdam
Reinier de Graaf Hospital - SSDZ
Other Contributor(s)
Abstract
Background: INTELLiVENT–Adaptive Support Ventilation (ASV) is a fully automated closed-loop mode of ventilation for use in critically ill patients. Evidence for benefit of INTELLiVENT–ASV in comparison to ventilation that is not fully automated with regard to duration of ventilation and quality of breathing is largely lacking. We test the hypothesis that INTELLiVENT–ASV shortens time spent on a ventilator and improves the quality of breathing. Methods: The “Effects of Automated Closed–loop VenTilation versus Conventional Ventilation on Duration and Quality of Ventilation” (ACTiVE) study is an international, multicenter, two-group randomized clinical superiority trial. In total, 1200 intensive care unit (ICU) patients with an anticipated duration of ventilation of > 24 h will be randomly assigned to one of the two ventilation strategies. Investigators screen patients aged 18 years or older at start of invasive ventilation in the ICU. Patients either receive automated ventilation by means of INTELLiVENT–ASV, or ventilation that is not automated by means of a conventional ventilation mode. The primary endpoint is the number of days free from ventilation and alive at day 28; secondary endpoints are quality of breathing using granular breath-by-breath analysis of ventilation parameters and variables in a time frame of 24 h early after the start of invasive ventilation, duration of ventilation in survivors, ICU and hospital length of stay (LOS), and mortality rates in the ICU and hospital, and at 28 and 90 days. Discussion: ACTiVE is one of the first randomized clinical trials that is adequately powered to compare the effects of automated closed-loop ventilation versus conventional ventilation on duration of ventilation and quality of breathing in invasively ventilated critically ill patients. The results of ACTiVE will support intensivist in their choices regarding the use of automated ventilation. Trial registration: ACTiVE is registered in clinicaltrials.gov (study identifier: NCT04593810) on 20 October 2020.