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.

Autor: Botta M; Department of Intensive Care, Amsterdam UMC location University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands. m.botta@amsterdamumc.nl., Tsonas AM; Department of Intensive Care, Amsterdam UMC location University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands., Sinnige JS; Department of Intensive Care, Amsterdam UMC location University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands., De Bie AJR; Department of Intensive Care, Catharina Hospital Eindhoven, Eindhoven, The Netherlands., Bindels AJGH; Department of Intensive Care, Catharina Hospital Eindhoven, Eindhoven, The Netherlands., Ball L; Department of Anesthesia and Intensive Care, San Martino Polyclinic Hospital, IRCCS for Oncology and Neurosciences, Genova, Italy., Battaglini D; Department of Anesthesia and Intensive Care, San Martino Polyclinic Hospital, IRCCS for Oncology and Neurosciences, Genova, Italy., Brunetti I; Department of Anesthesia and Intensive Care, San Martino Polyclinic Hospital, IRCCS for Oncology and Neurosciences, Genova, Italy., Buiteman-Kruizinga LA; Department of Intensive Care, Amsterdam UMC location University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.; Department of Intensive Care, Reinier de Graaf Hospital, Delft, The Netherlands., van der Heiden PLJ; Department of Intensive Care, Reinier de Graaf Hospital, Delft, The Netherlands., de Jonge E; Department of Intensive Care, Leiden University Medical Centre, Leiden, The Netherlands., Mojoli F; Department of Anesthesia and Intensive Care, San Matteo Polyclinic Foundation, University of Pavia, Pavia, Italy., Robba C; Department of Anesthesia and Intensive Care, San Martino Polyclinic Hospital, IRCCS for Oncology and Neurosciences, Genova, Italy., Schoe A; Department of Intensive Care, Leiden University Medical Centre, Leiden, The Netherlands., Paulus F; Department of Intensive Care, Amsterdam UMC location University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.; Faculty of Health, ACHIEVE, Centre of Applied Research, Amsterdam University of Applied Sciences, Amsterdam, The Netherlands., Pelosi P; Department of Anesthesia and Intensive Care, San Martino Polyclinic Hospital, IRCCS for Oncology and Neurosciences, Genova, Italy.; Department of Surgical Sciences and Integrated Diagnostic (DISC), University of Genova, Genova, Italy., Neto AS; Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.; Department of Critical Care Medicine, Hospital Israelita Albert Einstein, São Paulo, Brazil., Horn J; Department of Intensive Care, Amsterdam UMC location University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.; Amsterdam Neuroscience, Amsterdam UMC Research Institute, Amsterdam, The Netherlands., Schultz MJ; Department of Intensive Care, Amsterdam UMC location University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.; Mahidol-Oxford Tropical Medicine Research Unit (MORU), Mahidol University, Bangkok, Thailand.; Nuffield Department of Medicine, University of Oxford, Oxford, UK.; Department of Research and Development, Hamilton Medical AG, Bonaduz, Switzerland.
Jazyk: angličtina
Zdroj: Trials [Trials] 2022 Apr 23; Vol. 23 (1), pp. 348. Date of Electronic Publication: 2022 Apr 23.
DOI: 10.1186/s13063-022-06286-w
Abstrakt: 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.
(© 2022. The Author(s).)
Databáze: MEDLINE
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