I-ASV in Cardiac Surgery

Ventilator Lung Clinical Trial

— POSITiVE II  

Official title:

POStoperative INTELLiVENT-Adaptive Support VEntilation in Cardiac Surgery Patients II (POSITiVE II) - a Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06178510
• Other study ID #: POSITiVE II v1.1
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: August 2025

Study information

• Verified date: December 2023
• Source: Medical University of Vienna
• Contact: Edda Tschernko, MD
• Phone: 00 43 1 40400 41090
• Email: edda.tschernko[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 328
• Est. completion date: August 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Ventilator Lung

Intervention

Device:
• INTELLiVENT-ASV.
INTELLiVENT-ASV® is a closed-loop ventilation mode that automatically adjusts respiratory rate and tidal volume according to the oxygen and ventilatory patient needs

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of ventilation	The primary outcome is quality of ventilation, which is the proportion of time spent in three predefined and previously used zones of ventilation in the first 2 hours of postoperative ventilation.; An optimal zone = Tidal volume (TV) = 4-8 ml/kg of the predicted body weight (PBW) with an EtCO2 = 30-45mmHg, a plateau pressure = <31cmH2O and SpO2 = 93-98%.; An acceptable zone = TV = 8-12 ml/kg of PBW with an EtCO2 = 25-30 or 45-50mmHg, a plateau pressure = 31-35 cmH2O and SpO2 = 85-93% or >98%.; An unacceptable zone = TV >12 ml/kg of PBW or an EtCO2 = <25 or >50mmHg, plateau pressure >35 cmH2O or SpO2 = <85%.	During the first 2 hours, since admission on the ICU with the start of the intervention ventilation mode.
Secondary	ICU nursing staff workload	ICU nursing staff workload, which is captured by the ventilator software collecting data on alarms (number of alarms, types of alarm, duration of alarm, responses to alarm, alarm settings and adjustments, breath-by-breath alarm data, and any manual intervention at the ventilator) during postoperative care in the ICU	24 hours
Secondary	Duration of postoperative ventilation	The time from admission on the ICU until extubation.	8 hours or until extubation
Secondary	Patient-ventilator asynchrony	patient-ventilator asynchrony requiring deepening of sedation and/or administration of muscle relaxants	Up to 6 hours of mechanical ventilation time
Secondary	Proportion of breath spent in zones of ventilation	Proportion of breaths spent in predefined and previously used zones of ventilation in the first 6 hours of postoperative ventilation.; An optimal zone = Tidal volume (TV) = 4-8 ml/kg of the predicted body weight (PBW) with an EtCO2 = 30-45mmHg, a plateau pressure = <31cmH2O and SpO2 = 93-98%.; An acceptable zone = TV = 8-12 ml/kg of PBW with an EtCO2 = 25-30 or 45-50mmHg, a plateau pressure = 31-35 cmH2O and SpO2 = 85-93% or >98%.; An unacceptable zone = TV >12 ml/kg of PBW or an EtCO2 = <25 or >50mmHg, plateau pressure >35 cmH2O or SpO2 = <85%.	Up to 6 hours of mechanical ventilation time
Secondary	ICU length of stay	Length of stay in the ICU	From date of ICU admission until the date of ICU discharge, assessed up to 30 days
Secondary	Hospital length of stay	Length of stay in hospital	From date of hospital admission until the date of hospital discharge, assessed up to 30 days
Secondary	Mortality	Mortality in ICU or hospital	28-day