I-ASV in Cardiac Surgery

Not Applicable

Recruiting

• Conditions: Ventilator Lung
• Interventions: Device: INTELLiVENT-ASV.

• Registration Number: NCT06178510
• Lead Sponsor: Medical University of Vienna

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.

Study Timeline

• Study First Submitted: 2023-12-04
• Study First Submitted QC: 2023-12-20
• Study First Posted: 2023-12-21
• Study Start: 2024-05-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-04
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 328

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
INTELLiVENT-ASV	INTELLiVENT-ASV.	The ventilator set parameters such as tidal volume, respiratory rate, and positive end-expiratory pressure to ensure adequate ventilation and oxygenation. The investigators monitor it and define clinical target.

Primary Outcome Measures

Name	Time	Method
Quality of ventilation	During the first 2 hours, since admission on the ICU with the start of the intervention ventilation mode.	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%.

Secondary Outcome Measures

Name	Time	Method
Proportion of breath spent in zones of ventilation	Up to 6 hours of mechanical ventilation time	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%.
ICU nursing staff workload	24 hours	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
Patient-ventilator asynchrony	Up to 6 hours of mechanical ventilation time	patient-ventilator asynchrony requiring deepening of sedation and/or administration of muscle relaxants
ICU length of stay	From date of ICU admission until the date of ICU discharge, assessed up to 30 days	Length of stay in the ICU
Hospital length of stay	From date of hospital admission until the date of hospital discharge, assessed up to 30 days	Length of stay in hospital
Duration of postoperative ventilation	8 hours or until extubation	The time from admission on the ICU until extubation.
Mortality	28-day	Mortality in ICU or hospital

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria