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. 2024 Jul 3;25(1):449.
doi: 10.1186/s13063-024-08296-2.

POStoperative INTELLiVENT-adaptive support VEntilation in cardiac surgery patients (POSITiVE) II-study protocol of a randomized clinical trial

Martin H Bernardi  1 , Dominique Bettex  2 , Laura A Buiteman-Kruizinga  3   4 , Ashley de Bie  5 , Matthias Hoffmann  2 , Janine de Kleijn  5 , Simon Corrado Serafini  6   3   7 , Manon A Molenaar  3 , Frederique Paulus  3 , Jasminka Peršec  8 , Ary Serpa Neto  9   10   11 , Reto Schuepbach  2 , Paolo Severgnini  12 , Andrej Šribar  8 , Marcus J Schultz  6   3 , Edda Tschernko  6 ; POSITiVE II–investigators
Affiliations

POStoperative INTELLiVENT-adaptive support VEntilation in cardiac surgery patients (POSITiVE) II-study protocol of a randomized clinical trial

Martin H Bernardi et al. Trials. .

Abstract

Background: One single-center randomized clinical trial showed that INTELLiVENT-adaptive support ventilation (ASV) is superior to conventional ventilation with respect to the quality of ventilation in post-cardiac surgery patients. Other studies showed that this automated ventilation mode reduces the number of manual interventions at the ventilator in various types of critically ill patients. In this multicenter study in patients post-cardiac surgery, we test the hypothesis that INTELLiVENT-ASV is superior to conventional ventilation with respect to the quality of ventilation.

Methods: "POStoperative INTELLiVENT-adaptive support VEntilation in cardiac surgery patients II (POSITiVE II)" is an international, multicenter, two-group randomized clinical superiority trial. In total, 328 cardiac surgery patients will be randomized. Investigators screen patients aged > 18 years of age, scheduled for elective cardiac surgery, and expected to receive postoperative ventilation in the ICU for longer than 2 h. 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 quality of ventilation, defined as the proportion of postoperative ventilation time characterized by exposure to predefined optimal, acceptable, and critical (injurious) ventilatory parameters in the first two postoperative hours. One major secondary endpoint is ICU team staff workload, captured by the ventilator software collecting manual settings on alarms. Patient-centered endpoints include duration of postoperative ventilation and length of stay in ICU.

Discussion: POSITiVE II is the first international, multicenter, randomized clinical trial designed to confirm that POStoperative INTELLiVENT-ASV is superior to non-automated conventional ventilation and secondary to determine if this closed-loop ventilation mode reduces ICU team staff workload. The results of POSITiVE II will support intensive care teams in their choices regarding the use of automated ventilation in postoperative care of uncomplicated cardiac surgery patients.

Trial registration: Clinicaltrials.gov NCT06178510 . Registered on December 4, 2023.

Keywords: Automation; Cardiac surgery; Closed-loop; I-ASV; INTELLiVENT-ASV; Intensive care; Invasive ventilation; Mechanical ventilation; Postoperative ventilation; Randomized clinical trial.

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Conflict of interest statement

Laura Buiteman–Kruizinga received fees from Hamilton Medical AG for lecturing. Prof Reto Schuepbach declares ongoing studies with Hamilton medical and an education sponsorship. Prof Marcus J. Schultz was Team Leader Medical Research at Hamilton Medical AG, Bonaduz, Switzerland, from January 2022 till January 2023, and receives grants from Zorgonderzoek Medische wetenschappen (ZonMw) in the Netherlands. The other authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Schedule of enrolment, interventions, and assessments. a breath-by-breath analysis of ventilation parameters and variables in a time frame of 2 hours early after start of invasive ventilation; b for a maximum of 24 hours or until extubation; c for a maximum of 6 hours or until extubation
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