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, pp. 348

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.

Authors 19

1. Michela Botta corresponding

   Amsterdam UMC Location University of Amsterdam

   Affiliation as printed

   Department of Intensive Care, Amsterdam UMC location University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands. m.botta@amsterdamumc.nl

   Department of Intensive Care, Amsterdam UMC location University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands

2. Anissa M. Tsonas

   Amsterdam UMC Location University of Amsterdam

   Affiliation as printed

   Department of Intensive Care, Amsterdam UMC location University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands

3. Jante S. Sinnige

   Amsterdam UMC Location University of Amsterdam

   Affiliation as printed

   Department of Intensive Care, Amsterdam UMC location University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands

4. Ashley J.R. De Bie

   Catharina Ziekenhuis

   Affiliation as printed

   Department of Intensive Care, Catharina Hospital Eindhoven, Eindhoven, The Netherlands

5. Alexander J. G. H. Bindels

   Catharina Ziekenhuis

   Affiliation as printed

   Department of Intensive Care, Catharina Hospital Eindhoven, Eindhoven, The Netherlands

6. Lorenzo Ball

   Ospedale Policlinico San Martino

   Affiliation as printed

   Department of Anesthesia and Intensive Care, San Martino Polyclinic Hospital, IRCCS for Oncology and Neurosciences, Genova, Italy

7. Denise Battaglini

   Ospedale Policlinico San Martino

   Affiliation as printed

   Department of Anesthesia and Intensive Care, San Martino Polyclinic Hospital, IRCCS for Oncology and Neurosciences, Genova, Italy

8. Iole Brunetti

   Ospedale Policlinico San Martino

   Affiliation as printed

   Department of Anesthesia and Intensive Care, San Martino Polyclinic Hospital, IRCCS for Oncology and Neurosciences, Genova, Italy

9. Laura A. Buiteman‐Kruizinga

   Amsterdam UMC Location University of Amsterdam · Reinier de Graaf Hospital

   Affiliation as printed

   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

10. Pim L. J. van der Heiden

    Reinier de Graaf Hospital

    Affiliation as printed

    Department of Intensive Care, Reinier de Graaf Hospital, Delft, The Netherlands

11. Evert de Jonge Aachen Department of Intensive Care

    Leiden University · Leiden University Medical Center

    Affiliation as printed

    Department of Intensive Care, Leiden University Medical Centre, Leiden, The Netherlands

12. Francesco Mojoli

    University of Pavia · Policlinico San Matteo Fondazione

    Affiliation as printed

    Department of Anesthesia and Intensive Care, San Matteo Polyclinic Foundation, University of Pavia, Pavia, Italy

13. Chiara Robba

    Ospedale Policlinico San Martino

    Affiliation as printed

    Department of Anesthesia and Intensive Care, San Martino Polyclinic Hospital, IRCCS for Oncology and Neurosciences, Genova, Italy

14. Abraham Schoe Aachen Department of Intensive Care

    Leiden University · Leiden University Medical Center

    Affiliation as printed

    Department of Intensive Care, Leiden University Medical Centre, Leiden, The Netherlands

15. Frederique Paulus

    Amsterdam UMC Location University of Amsterdam · Amsterdam University of Applied Sciences

    Affiliation as printed

    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

16. Paolo P. Pelosi

    Ospedale Policlinico San Martino · University of Genoa

    Affiliation as printed

    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

17. Ary Serpa Neto

    Hospital Israelita Albert Einstein · Monash University

    Affiliation as printed

    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

18. Janneke Horn

    Amsterdam UMC Location University of Amsterdam · Amsterdam Neuroscience · Amsterdam University Medical Centers

    Affiliation as printed

    Amsterdam Neuroscience, Amsterdam UMC Research Institute, Amsterdam, The Netherlands

    Department of Intensive Care, Amsterdam UMC location University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands

19. Marcus Josephus Schultz

    Mahidol University · Amsterdam UMC Location University of Amsterdam · University of Oxford · Hamilton Medical (Switzerland) · Mahidol Oxford Tropical Medicine Research Unit

    Affiliation as printed

    Department of Intensive Care, Amsterdam UMC location University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands

    Department of Research and Development, Hamilton Medical AG, Bonaduz, Switzerland

    Mahidol-Oxford Tropical Medicine Research Unit (MORU), Mahidol University, Bangkok, Thailand

    Nuffield Department of Medicine, University of Oxford, Oxford, UK

    Mahidol–Oxford Tropical Medicine Research Unit (MORU), Mahidol University, Bangkok, Thailand