Clinical trial NCT06178510: I-ASV in Cardiac Surgery
Official title: POStoperative INTELLiVENT-adaptive Support VEntilation in Cardiac Surgery Patients II (POSITiVE II) - a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ventilator Lung
Keywords: Adaptative Support Ventilation
INTELLiVENT
Cardiac Surgery
Workload
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: University Hospital Dubrava
name: UniversitÃ degli Studi dell'Insubria
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: University of Zurich
First posted: 2023-12-21
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 patients after cardiac surgery.

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 postoperative ventilation after cardiac surgery. This study will also determine the effects of INTELLiVENT-ASV on clinical outcomes, including (iii.) duration of postoperative ventilation and (iv.) length of stay in ICU.

Eligibility 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

Primary outcomes:
measure: Quality of ventilation
timeFrame: During the first 2 hours, since admission on the ICU with the start of the intervention ventilation mode.
Secondary outcomes:
measure: ICU nursing staff workload
timeFrame: 24 hours
measure: Duration of postoperative ventilation
timeFrame: 8 hours or until extubation
measure: Patient-ventilator asynchrony
timeFrame: Up to 6 hours of mechanical ventilation time
measure: Proportion of breath spent in zones of ventilation
timeFrame: Up to 6 hours of mechanical ventilation time
measure: ICU length of stay
timeFrame: From date of ICU admission until the date of ICU discharge, assessed up to 30 days
measure: Hospital length of stay
timeFrame: From date of hospital admission until the date of hospital discharge, assessed up to 30 days
measure: Mortality
timeFrame: 28-day
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Edda Tschernko, MD
role: PRINCIPAL_INVESTIGATOR
References: