Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Apr 23;23(1):348.
doi: 10.1186/s13063-022-06286-w.

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  1 , Anissa M Tsonas  2 , Jante S Sinnige  2 , Ashley J R De Bie  3 , Alexander J G H Bindels  3 , Lorenzo Ball  4 , Denise Battaglini  4 , Iole Brunetti  4 , Laura A Buiteman-Kruizinga  2   5 , Pim L J van der Heiden  5 , Evert de Jonge  6 , Francesco Mojoli  7 , Chiara Robba  4 , Abraham Schoe  6 , Frederique Paulus  2   8 , Paolo Pelosi  4   9 , Ary Serpa Neto  10   11 , Janneke Horn  2   12 , Marcus J Schultz  2   13   14   15 ; ACTiVE collaborative group
Collaborators, Affiliations

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 et al. Trials. .

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.

Keywords: Automation; Closed-loop; ICU; INTELLiVENT–ASV; Intensive care; Invasive ventilation; I–ASV; Mechanical ventilation; Randomized controlled trial.

PubMed Disclaimer

Conflict of interest statement

Prof M.J. Schultz is since January 2022 Team Leader Medical Affairs at Hamilton Medical AG, Bonaduz, Switzerland. The other authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
CONSORT flow diagram
Fig. 2
Fig. 2
Schedule of enrollment, intervention, and assessments
See this image and copyright information in PMC

References

    1. Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2013;369(22):2126–2136. doi: 10.1056/NEJMra1208707. - DOI - PubMed
    1. Serpa Neto A, Schultz MJ, Slutsky AS. Current concepts of protective ventilation during general anaesthesia. Swiss Med Wkly. 2015;145:w14211. doi: 10.4414/smw.2015.14211. - DOI - PubMed
    1. Jaber S, Petrof BJ, Jung B, Chanques G, Berthet JP, Rabuel C, Bouyabrine H, Courouble P, Koechlin-Ramonatxo C, Sebbane M, Similowski T, Scheuermann V, Mebazaa A, Capdevila X, Mornet D, Mercier J, Lacampagne A, Philips A, Matecki S. Rapidly progressive diaphragmatic weakness and injury during mechanical ventilation in humans. Am J Respir Crit Care Med. 2011;183(3):364–371. doi: 10.1164/rccm.201004-0670OC. - DOI - PubMed
    1. Dres M, Goligher EC, Heunks LMA, Brochard LJ. Critical illness-associated diaphragm weakness. Intensive Care Med. 2017;43(10):1441–1452. doi: 10.1007/s00134-017-4928-4. - DOI - PubMed
    1. Putensen C, Theuerkauf N, Zinserling J, Wrigge H, Pelosi P. Meta-analysis: ventilation strategies and outcomes of the acute respiratory distress syndrome and acute lung injury. Ann Intern Med. 2009;151(8):566–576. doi: 10.7326/0003-4819-151-8-200910200-00011. - DOI - PubMed

Publication types

Associated data