I-ASV in Cardiac Surgery

Medical University of Vienna328 enrolled

Overview

'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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

328

Conditions

Ventilator Lung

Interventions

INTELLiVENT-ASV.DEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical University of Vienna

Vienna, State of Vienna, Austria

RECRUITING

Outcomes

Primary Outcomes

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%.

Time frame: During the first 2 hours, since admission on the ICU with the start of the intervention ventilation mode.

Secondary Outcomes

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

Time frame: 24 hours

Duration of postoperative ventilation

The time from admission on the ICU until extubation.

Time frame: 8 hours or until extubation

Patient-ventilator asynchrony

patient-ventilator asynchrony requiring deepening of sedation and/or administration of muscle relaxants

Time frame: Up to 6 hours of mechanical ventilation time

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%.

Central Contacts

Edda Tschernko, MD

CONTACT

00 43 1 40400 41090 edda.tschernko@meduniwien.ac.at

Martin H. Bernardi, MD

CONTACT

00 43 1 40400 41090 martin.bernardi@meduniwien.ac.at

Data from ClinicalTrials.gov

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