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.

Details

Title
POStoperative INTELLiVENT-adaptive support VEntilation in cardiac surgery patients (POSITiVE) II—study protocol of a randomized clinical trial
Author
Bernardi, Martin H. 1   VIAFID ORCID Logo  ; Bettex, Dominique 2 ; Buiteman–Kruizinga, Laura A. 3 ; de Bie, Ashley 4 ; Hoffmann, Matthias 2 ; de Kleijn, Janine 4 ; Serafini, Simon Corrado 5 ; Molenaar, Manon A. 6 ; Paulus, Frederique 6 ; Peršec, Jasminka 7 ; Neto, Ary Serpa 8 ; Schuepbach, Reto 2 ; Severgnini, Paolo 9 ; Šribar, Andrej 7 ; Schultz, Marcus J. 10 ; Tschernko, Edda 1 

1  Medical University of Vienna, Department of Anesthesia, General Intensive Care and Pain Management––Division of Cardiothoracic and Vascular Anesthesia & Critical Care Medicine, Vienna, Austria (GRID:grid.22937.3d) (ISNI:0000 0000 9259 8492) 
2  University Hospital Zurich and University of Zurich, Zurich, Switzerland (GRID:grid.7400.3) (ISNI:0000 0004 1937 0650) 
3  Amsterdam UMC, Location AMC, Department of Intensive Care, Amsterdam, the Netherlands (GRID:grid.509540.d) (ISNI:0000 0004 6880 3010); Reinier de Graaf Hospital, Department of Intensive Care, Delft, the Netherlands (GRID:grid.415868.6) (ISNI:0000 0004 0624 5690) 
4  Catharina Hospital Eindhoven, Department of Intensive Care, Eindhoven, the Netherlands (GRID:grid.413532.2) (ISNI:0000 0004 0398 8384) 
5  Medical University of Vienna, Department of Anesthesia, General Intensive Care and Pain Management––Division of Cardiothoracic and Vascular Anesthesia & Critical Care Medicine, Vienna, Austria (GRID:grid.22937.3d) (ISNI:0000 0000 9259 8492); Amsterdam UMC, Location AMC, Department of Intensive Care, Amsterdam, the Netherlands (GRID:grid.509540.d) (ISNI:0000 0004 6880 3010); University of Genoa, Department of Surgical Sciences and Integrated Diagnostics (DISC), Genoa, Italy (GRID:grid.5606.5) (ISNI:0000 0001 2151 3065) 
6  Amsterdam UMC, Location AMC, Department of Intensive Care, Amsterdam, the Netherlands (GRID:grid.509540.d) (ISNI:0000 0004 6880 3010) 
7  University Hospital Dubrava, Clinical Department of Anesthesiology, Resuscitation and Intensive Care Medicine, Zagreb, Croatia (GRID:grid.412095.b) (ISNI:0000 0004 0631 385X) 
8  Hospital Israelita Albert Einstein, Department of Critical Care Medicine, Sao Paolo, Brazil (GRID:grid.413562.7) (ISNI:0000 0001 0385 1941); Monash University, Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), School of Public Health and Preventive Medicine, Melbourne, Australia (GRID:grid.1002.3) (ISNI:0000 0004 1936 7857); Austin Hospital, Melbourne Medical School, University of Melbourne, Department of Intensive Care, Melbourne, Australia (GRID:grid.414094.c) (ISNI:0000 0001 0162 7225) 
9  University of Insubria, Cardiac Surgery Intensive Care Unit, ASST Dei Sette Laghi, Varese, Italy (GRID:grid.18147.3b) (ISNI:0000 0001 2172 4807) 
10  Medical University of Vienna, Department of Anesthesia, General Intensive Care and Pain Management––Division of Cardiothoracic and Vascular Anesthesia & Critical Care Medicine, Vienna, Austria (GRID:grid.22937.3d) (ISNI:0000 0000 9259 8492); Amsterdam UMC, Location AMC, Department of Intensive Care, Amsterdam, the Netherlands (GRID:grid.509540.d) (ISNI:0000 0004 6880 3010) 
Pages
449
Publication year
2024
Publication date
Dec 2024
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-024-08296-2
ProQuest document ID
3075491974
Copyright
© The Author(s) 2024. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.