Evidence map›Paper›PMID 38961468›Full record

ArticleTrials2024

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

Martin H Bernardi, Dominique Bettex, Laura A Buiteman-Kruizinga, Ashley de Bie, Matthias Hoffmann, Janine de Kleijn, Simon Corrado Serafini, Manon A Molenaar, Frederique Paulus, Jasminka Peršec and 7 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06178510 (POStoperative INTELLiVENT-adaptive Support VEntilation in Cardiac Surgery Patients II), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06178510 narecruitingnot on this map

POStoperative INTELLiVENT-adaptive Support VEntilation in Cardiac Surgery Patients II (POSITiVE II) - a Randomized Clinical Trial

TypeinterventionalSponsorMedical University of ViennaRan2024 to 2025Enrolled328ConditionsVentilator LungArmsINTELLiVENT-ASV.
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Martin H BernardiDepartment of Anesthesia, General Intensive Care and Pain Management--Division of Cardiothoracic and Vascular Anesthesia & Critical Care Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. martin.bernardi@meduniwien.ac.at.ORCID http://orcid.org/0000-0002-8297-898X
Dominique BettexUniversity Hospital Zurich and University of Zurich, Zurich, Switzerland.
Laura A Buiteman-KruizingaDepartment of Intensive Care, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.
Ashley de BieDepartment of Intensive Care, Catharina Hospital Eindhoven, Eindhoven, the Netherlands.
Matthias HoffmannUniversity Hospital Zurich and University of Zurich, Zurich, Switzerland.
Janine de KleijnDepartment of Intensive Care, Catharina Hospital Eindhoven, Eindhoven, the Netherlands.
Simon Corrado SerafiniDepartment of Anesthesia, General Intensive Care and Pain Management--Division of Cardiothoracic and Vascular Anesthesia & Critical Care Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.
Manon A MolenaarDepartment of Intensive Care, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.
Frederique PaulusDepartment of Intensive Care, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.
Jasminka PeršecClinical Department of Anesthesiology, Resuscitation and Intensive Care Medicine, University Hospital Dubrava, Zagreb, Croatia.
Ary Serpa NetoDepartment of Critical Care Medicine, Hospital Israelita Albert Einstein, Sao Paolo, Brazil.
Reto SchuepbachUniversity Hospital Zurich and University of Zurich, Zurich, Switzerland.
Paolo SevergniniCardiac Surgery Intensive Care Unit, ASST Dei Sette Laghi, University of Insubria, Varese, Italy.
Andrej ŠribarClinical Department of Anesthesiology, Resuscitation and Intensive Care Medicine, University Hospital Dubrava, Zagreb, Croatia.
Marcus J SchultzDepartment of Anesthesia, General Intensive Care and Pain Management--Division of Cardiothoracic and Vascular Anesthesia & Critical Care Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.
Edda TschernkoDepartment of Anesthesia, General Intensive Care and Pain Management--Division of Cardiothoracic and Vascular Anesthesia & Critical Care Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.
POSITiVE II–investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOne 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 registrationClinicaltrials.gov NCT06178510 . Registered on December 4, 2023.

Indexed as

Cardiac Surgical ProceduresMulticenter Studies as TopicEquivalence Trials as TopicHumansIntensive Care UnitsPostoperative CareRespiration, ArtificialTime FactorsTreatment OutcomeAutomationCardiac surgeryClosed-loopI-ASVINTELLiVENT-ASVIntensive careInvasive ventilationMechanical ventilationPostoperative ventilationRandomized clinical trial

Identifiers

PMID38961468
PMCPMC11223327

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.