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Open Access 01-12-2022 | Study protocol

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

Authors: 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

Published in: Trials | Issue 1/2022

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.

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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
Authors: 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
Publication date: 01-12-2022
Publisher: BioMed Central
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06286-w

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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