Actively Recruiting

Phase Not Applicable
Age: 18Years - 120Years
All Genders
ID06178510

POStoperative INTELLiVENT-adaptive Support VEntilation in Cardiac Surgery Patients II (POSITiVE II) - 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

On this page

Sponsors

M

Medical University of Vienna

Lead Sponsor

U

University Hospital Dubrava

Collaborating Sponsor

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

Who Can Participate

Age: 18Years - 120Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged over 18 years
  • Scheduled for elective cardiac surgery
  • Expected to receive postoperative ventilation in the ICU for more than 2 hours
Not Eligible

You will not qualify if you...

  • Emergency or semi-elective surgery
  • Surgery other than CABG, valve replacement or repair, or combination
  • Enrolled in another interventional trial
  • No written informed consent obtained
  • History of recent pneumectomy or lobectomy
  • History of COPD with home oxygen
  • Body mass index over 35
  • Preoperative forced expiratory volume (FeV1)/forced vital capacity (VC) less than 50% (if available)
  • Preoperative arterial oxygen partial pressure (PaO2) below 60 mm Hg at room air
  • Preoperative arterial carbon dioxide partial pressure (PaCO2) above 50 mm Hg
  • Preoperative left ventricular ejection fraction less than 30% (if available)
  • Preoperative systolic pulmonary artery pressure above 60 mm Hg (if available)
  • 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

AI-Screening

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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

Trial Site Locations

Total: 1 location

1

Medical University of Vienna

Vienna, State of Vienna, Austria, A-1090

Actively Recruiting

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Research Team

E

Edda Tschernko, MD

M

Martin H. Bernardi, MD

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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Published Research Related To This Trial

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...

https://pubmed.ncbi.nlm.nih.gov/38961468