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
Michela Botta,
Anissa M. Tsonas,
Jante S. Sinnige,
Ashley J. R. De Bie,
Alexander J. G. H. Bindels,
Lorenzo Ball,
Denise Battaglini,
Iole Brunetti,
Laura A. Buiteman–Kruizinga,
Pim L. J. van der Heiden,
Evert de Jonge,
Francesco Mojoli,
Chiara Robba,
Abraham Schoe,
Frederique Paulus,
Paolo Pelosi,
Ary Serpa Neto,
Janneke Horn,
Marcus J. Schultz,
The ACTiVE collaborative group
Affiliations
Michela Botta
Department of Intensive Care, Amsterdam UMC location University of Amsterdam
Anissa M. Tsonas
Department of Intensive Care, Amsterdam UMC location University of Amsterdam
Jante S. Sinnige
Department of Intensive Care, Amsterdam UMC location University of Amsterdam
Ashley J. R. De Bie
Department of Intensive Care, Catharina Hospital Eindhoven
Alexander J. G. H. Bindels
Department of Intensive Care, Catharina Hospital Eindhoven
Lorenzo Ball
Department of Anesthesia and Intensive Care, San Martino Polyclinic Hospital, IRCCS for Oncology and Neurosciences
Denise Battaglini
Department of Anesthesia and Intensive Care, San Martino Polyclinic Hospital, IRCCS for Oncology and Neurosciences
Iole Brunetti
Department of Anesthesia and Intensive Care, San Martino Polyclinic Hospital, IRCCS for Oncology and Neurosciences
Laura A. Buiteman–Kruizinga
Department of Intensive Care, Amsterdam UMC location University of Amsterdam
Pim L. J. van der Heiden
Department of Intensive Care, Reinier de Graaf Hospital
Evert de Jonge
Department of Intensive Care, Leiden University Medical Centre
Francesco Mojoli
Department of Anesthesia and Intensive Care, San Matteo Polyclinic Foundation, University of Pavia
Chiara Robba
Department of Anesthesia and Intensive Care, San Martino Polyclinic Hospital, IRCCS for Oncology and Neurosciences
Abraham Schoe
Department of Intensive Care, Leiden University Medical Centre
Frederique Paulus
Department of Intensive Care, Amsterdam UMC location University of Amsterdam
Paolo Pelosi
Department of Anesthesia and Intensive Care, San Martino Polyclinic Hospital, IRCCS for Oncology and Neurosciences
Ary Serpa Neto
Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University
Janneke Horn
Department of Intensive Care, Amsterdam UMC location University of Amsterdam
Marcus J. Schultz
Department of Intensive Care, Amsterdam UMC location University of Amsterdam
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.
