I-ASV in Cardiac Surgery
Recruiting now · Not applicable
Conditions studied: Ventilator Lung
In brief
'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.
Key facts
- Study ID
- NCT06178510
- Run by
- Medical University of Vienna
- People needed
- 328
- Starts
- 2024-05-31
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2024-11-04
Who can join
Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Medical University of Vienna — Vienna, State of Vienna, Austria (enrolling)
Full record on ClinicalTrials.gov
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