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| Name | Class |
|---|---|
| University Hospital Dubrava | OTHER |
| Università degli Studi dell'Insubria | OTHER |
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | OTHER |
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'POStoperative INTELLiVENT-adaptive support VEntilation in cardiac surgery patients II (POSITiVE II) is an investigator-initiated, international, multicenter, parallel, randomized clinical trial in patients after cardiac surgery.
To compare INTELLiVENT-ASV with conventional ventilation with respect to (i.) quality of ventilation; and (ii.) ICU nursing staff workload in an international cohort of participants receiving postoperative ventilation after cardiac surgery. This study will also determine the effects of INTELLiVENT-ASV on clinical outcomes, including (iii.) duration of postoperative ventilation and (iv.) length of stay in ICU.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INTELLiVENT-ASV | Other | The ventilator set parameters such as tidal volume, respiratory rate, and positive end-expiratory pressure to ensure adequate ventilation and oxygenation. The investigators monitor it and define clinical target. |
|
| conventional ventilation | No Intervention | The investigators set and monitor parameters such as tidal volume, respiratory rate, and positive end-expiratory pressure to ensure adequate ventilation and oxygenation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INTELLiVENT-ASV. | Device | INTELLiVENT-ASV® is a closed-loop ventilation mode that automatically adjusts respiratory rate and tidal volume according to the oxygen and ventilatory patient needs |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of ventilation | The primary outcome is quality of ventilation, which is the proportion of time spent in three predefined and previously used zones of ventilation in the first 2 hours of postoperative ventilation.
| During the first 2 hours, since admission on the ICU with the start of the intervention ventilation mode. |
| Measure | Description | Time Frame |
|---|---|---|
| ICU nursing staff workload | ICU nursing staff workload, which is captured by the ventilator software collecting data on alarms (number of alarms, types of alarm, duration of alarm, responses to alarm, alarm settings and adjustments, breath-by-breath alarm data, and any manual intervention at the ventilator) during postoperative care in the ICU | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
any emergency or semi-elective surgery (precluding informed written consent);
any surgery other than CABG, valve replacement or repair, or a combination (i.e., patients planned for surgery for congenital heart disease, or scheduled for heart transplantation are excluded);
enrolled in another interventional trail;
no written informed consent obtained;
history of recent pneumectomy or lobectomy;
history of COPD with oxygen at home;
body mass index > 35;
preoperative forced expiratory volume in the first second (FeV1)/forced vital capacity (VC) < 50% (if available);
preoperative arterial oxygen partial pressure (PaO2) < 60 mm Hg (at room air);
preoperative arterial carbon dioxide partial pressure (PaCO2) > 50 mm Hg;
preoperative left ventricular ejection fraction < 30% (if available);
preoperative systolic pulmonary artery pressure > 60 mm Hg (if available);
preoperative left ventricular mechanical support, e.g., Impella®; or
preoperative use of veno-venous or veno-arterial extracorporeal support
At the end of surgery, patients are additionally excluded if a patient:
cannot be weaned from the extracorporeal support; or
unexpectedly needs implementation of an assist device
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Edda Tschernko, MD | Contact | 00 43 1 40400 41090 | edda.tschernko@meduniwien.ac.at | |
| Martin H. Bernardi, MD | Contact | 00 43 1 40400 41090 | martin.bernardi@meduniwien.ac.at |
| Name | Affiliation | Role |
|---|---|---|
| Edda Tschernko, MD | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Recruiting | Vienna | State of Vienna | A-1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38961468 | Derived | Bernardi MH, Bettex D, Buiteman-Kruizinga LA, de Bie A, Hoffmann M, de Kleijn J, Serafini SC, Molenaar MA, Paulus F, Persec J, Neto AS, Schuepbach R, Severgnini P, Sribar A, Schultz MJ, Tschernko E; POSITiVE II-investigators. POStoperative INTELLiVENT-adaptive support VEntilation in cardiac surgery patients (POSITiVE) II-study protocol of a randomized clinical trial. Trials. 2024 Jul 3;25(1):449. doi: 10.1186/s13063-024-08296-2. |
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The results of the study will find their way into (inter-) national scientific journals and guidelines.
We will submit a summary of results to scientific journals in the field of anesthesiology.
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| University of Zurich |
| OTHER |
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| Duration of postoperative ventilation | The time from admission on the ICU until extubation. | 8 hours or until extubation |
| Patient-ventilator asynchrony | patient-ventilator asynchrony requiring deepening of sedation and/or administration of muscle relaxants | Up to 6 hours of mechanical ventilation time |
| Proportion of breath spent in zones of ventilation | Proportion of breaths spent in predefined and previously used zones of ventilation in the first 6 hours of postoperative ventilation.
| Up to 6 hours of mechanical ventilation time |
| ICU length of stay | Length of stay in the ICU | From date of ICU admission until the date of ICU discharge, assessed up to 30 days |
| Hospital length of stay | Length of stay in hospital | From date of hospital admission until the date of hospital discharge, assessed up to 30 days |
| Mortality | Mortality in ICU or hospital | 28-day |