Status:
RECRUITING
I-ASV in Cardiac Surgery
Lead Sponsor:
Medical University of Vienna
Collaborating Sponsors:
University Hospital Dubrava
Università degli Studi dell'Insubria
Conditions:
Ventilator Lung
Eligibility:
All Genders
18-120 years
Phase:
NA
Brief Summary
'POStoperative INTELLiVENT-adaptive support VEntilation in cardiac surgery patients II (POSITiVE II) is an investigator-initiated, international, multicenter, parallel, randomized clinical trial in pa...
Detailed Description
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 postoper...
Eligibility Criteria
Inclusion
- 1\. aged \> 18 years of age;
- 2\. scheduled for elective cardiac surgery; and
- 3\. expected to receive postoperative ventilation in the ICU for \> 2 hours.
Exclusion
- 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
Key Trial Info
Start Date :
May 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
328 Patients enrolled
Trial Details
Trial ID
NCT06178510
Start Date
May 31 2024
End Date
December 1 2025
Last Update
November 4 2024
Active Locations (1)
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1
Medical University of Vienna
Vienna, Vienna, Austria, A-1090