Postoperative INTELLiVENT Adaptive Support Ventilation Versus Conventional Ventilation After Cardiac Surgery A Randomized Clinical Trial
Led by Medical University of Vienna · Updated on 2024-11-04
328
Participants Needed
1
Research Sites
26 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the use of INTELLiVENT-ASV, an automated ventilation mode, compared to conventional ventilation in patients receiving postoperative ventilation after cardiac surgery. The study aims to assess the quality of ventilation, the workload on ICU nursing staff, and clinical outcomes such as the duration of postoperative ventilation and length of ICU stay. This international, randomized clinical trial includes adult patients undergoing elective cardiac surgery.
Participants will be randomly assigned to receive either INTELLiVENT-ASV, which automatically adjusts ventilation settings based on patient needs, or conventional ventilation where clinicians set and monitor parameters like tidal volume and respiratory rate. The study focuses on the early postoperative period, particularly the first two hours of ICU ventilation, with monitoring continuing through the duration of mechanical ventilation and ICU stay.
During the trial, patients will undergo continuous monitoring of ventilation quality, nursing workload, and clinical outcomes including ventilation duration and length of stay in ICU and hospital. Additional assessments include patient-ventilator synchrony and mortality within 28 days. The study involves detailed data collection during ICU admission and ventilation, with follow-up up to 30 days after admission to evaluate hospital outcomes.
CONDITIONS
Brief Title
I-ASV in Cardiac Surgery
Research Team
E
Edda Tschernko, MD
M
Martin H. Bernardi, MD
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Preoperative left ventricular mechanical support (e.g., Impella�)
Preoperative use of veno-venous or veno-arterial extracorporeal support
At surgery end, cannot be weaned from extracorporeal support
Unexpected need for assist device implementation
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Up to 8 hours or until extubation
Participants receive mechanical ventilation using either INTELLiVENT-ASV or conventional ventilation immediately after cardiac surgery while in the ICU.
Continuous monitoring during ventilation period
Post-operative Follow-up
Duration - Up to 30 days
Participants are monitored for clinical outcomes including ICU and hospital length of stay, nursing staff workload, and mortality.
Daily assessments in ICU and hospital
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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