Actively Recruiting
I-ASV in Cardiac Surgery
Led by Medical University of Vienna · Updated on 2024-11-04
328
Participants Needed
1
Research Sites
78 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
'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.
CONDITIONS
Official Title
I-ASV in Cardiac Surgery
Who Can Participate
Eligibility Criteria
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
You will not qualify if you...
- Undergoing emergency or semi-elective surgery without informed consent
- Scheduled for surgery other than coronary artery bypass grafting or valve repair/replacement
- Enrolled in another interventional trial
- No written informed consent obtained
- History of recent pneumectomy or lobectomy
- History of COPD requiring home oxygen
- Body mass index over 35
- Preoperative forced expiratory volume in one second/forced vital capacity less than 50% (if available)
- Preoperative arterial oxygen partial pressure below 60 mm Hg at room air
- Preoperative arterial carbon dioxide partial pressure above 50 mm Hg
- Preoperative left ventricular ejection fraction below 30% (if available)
- Preoperative systolic pulmonary artery pressure above 60 mm Hg (if available)
- Preoperative left ventricular mechanical support such as Impella
- Preoperative use of veno-venous or veno-arterial extracorporeal support
- Unable to wean from extracorporeal support at end of surgery
- Unexpected need for assist device implementation at end of surgery
AI-Screening
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Trial Site Locations
Total: 1 location
1
Medical University of Vienna
Vienna, State of Vienna, Austria, A-1090
Actively Recruiting
Research Team
E
Edda Tschernko, MD
CONTACT
M
Martin H. Bernardi, MD
CONTACT
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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