Using INTELLiVENT for ventilation after cardiac surgery
POStoperative INTELLiVENT-adaptive Support VEntilation in Cardiac Surgery Patients II (POSITiVE II) - a Randomized Clinical Trial
This study is testing whether a new breathing support method called INTELLiVENT can help patients recover better after heart surgery compared to traditional breathing methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 328 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna, State of Vienna) |
| Trial ID | NCT06178510 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares the effectiveness of INTELLiVENT-adaptive support ventilation (ASV) against conventional ventilation methods in patients recovering from cardiac surgery. It aims to assess the quality of ventilation and the workload on ICU nursing staff, while also evaluating clinical outcomes such as the duration of postoperative ventilation and length of ICU stay. The study involves an international cohort of participants and is designed to provide insights into the benefits of adaptive ventilation techniques in a critical care setting.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 scheduled for elective cardiac surgery who will require postoperative ventilation for more than 2 hours.
Not a fit: Patients undergoing emergency surgeries or those with significant pre-existing respiratory conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve ventilation quality and reduce ICU staff workload, leading to better patient outcomes.
How similar studies have performed: Previous studies have shown promising results with adaptive ventilation techniques, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 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 Criteria:
1. any emergency or semi-elective surgery (precluding informed written consent);
2. 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);
3. enrolled in another interventional trail;
4. no written informed consent obtained;
5. history of recent pneumectomy or lobectomy;
6. history of COPD with oxygen at home;
7. body mass index \> 35;
8. preoperative forced expiratory volume in the first second (FeV1)/forced vital capacity (VC) \< 50% (if available);
9. preoperative arterial oxygen partial pressure (PaO2) \< 60 mm Hg (at room air);
10. preoperative arterial carbon dioxide partial pressure (PaCO2) \> 50 mm Hg;
11. preoperative left ventricular ejection fraction \< 30% (if available);
12. preoperative systolic pulmonary artery pressure \> 60 mm Hg (if available);
13. preoperative left ventricular mechanical support, e.g., Impella®; or
14. preoperative use of veno-venous or veno-arterial extracorporeal support
At the end of surgery, patients are additionally excluded if a patient:
15. cannot be weaned from the extracorporeal support; or
16. unexpectedly needs implementation of an assist device
Where this trial is running
Vienna, State of Vienna
- Medical University of Vienna — Vienna, State of Vienna, Austria (Recruiting)
Study contacts
- Principal investigator: Edda Tschernko, MD — Medical University of Vienna
- Study coordinator: Edda Tschernko, MD
- Email: edda.tschernko@meduniwien.ac.at
- Phone: 00 43 1 40400 41090
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.