Research output: Contribution to journal › Article › Academic › peer-review
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. / ACTiVE collaborative group.
In: Trials, Vol. 23, No. 1, 348, 12.2022, p. 348.Research output: Contribution to journal › Article › Academic › peer-review
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TY - JOUR
T1 - 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
AU - Botta, Michela
AU - Tsonas, Anissa M.
AU - Sinnige, Jante S.
AU - de Bie, Ashley J. R.
AU - Bindels, Alexander J. G. H.
AU - Ball, Lorenzo
AU - Battaglini, Denise
AU - Brunetti, Iole
AU - Buiteman-Kruizinga, Laura A.
AU - van der Heiden, Pim L. J.
AU - de Jonge, Evert
AU - Mojoli, Francesco
AU - Robba, Chiara
AU - Schoe, Abraham
AU - Paulus, Frederique
AU - Pelosi, Paolo
AU - Neto, Ary Serpa
AU - Horn, Janneke
AU - ACTiVE collaborative group
AU - Schultz, Marcus J.
N1 - Funding Information: This study is funded by “The Netherlands Organization for health Research and Development” (ZonMw). This study is sponsored by the Amsterdam University Medical Centers, location AMC. The funder and sponsor have no role in the design of this study and will have no role in the data collection, analysis, and data interpretation and in writing the final report. Publisher Copyright: © 2022, The Author(s).
PY - 2022/12
Y1 - 2022/12
N2 - 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.
AB - 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.
KW - Automation
KW - Closed-loop
KW - ICU
KW - INTELLiVENT–ASV
KW - Intensive care
KW - Invasive ventilation
KW - I–ASV
KW - Mechanical ventilation
KW - Randomized controlled trial
UR - http://www.scopus.com/inward/record.url?scp=85128801834&partnerID=8YFLogxK
U2 - 10.1186/s13063-022-06286-w
DO - 10.1186/s13063-022-06286-w
M3 - Article
C2 - 35461264
VL - 23
SP - 348
JO - Trials
JF - Trials
SN - 1745-6215
IS - 1
M1 - 348
ER -
ID: 23351045