Ventilator Lung
Conditions
Keywords
Adaptative Support Ventilation, INTELLiVENT, Cardiac Surgery, Workload
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.
Interventions
DEVICEINTELLiVENT-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
Sponsors
University Hospital Dubrava
Università degli Studi dell'Insubria
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
University of Zurich
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Duration of postoperative ventilation | 8 hours or until extubation | The time from admission on the ICU until extubation. |
| Patient-ventilator asynchrony | Up to 6 hours of mechanical ventilation time | patient-ventilator asynchrony requiring deepening of sedation and/or administration of muscle relaxants |
| 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 |
| 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 |
| Mortality | 28-day | Mortality in ICU or hospital |
| 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 |
Countries
Austria
Contacts
Primary ContactEdda Tschernko, MD
Backup ContactMartin H. Bernardi, MD
Outcome results
None listed