I-ASV in Cardiac Surgery
ConditionVentilator Lung
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-120
SponsorMedical University of Vienna
About this trial
'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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
any emergency or semi-elective surgery (precluding informed written consent);
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);
enrolled in another interventional trail;
no written informed consent obtained;
Trial design
Design model
Parallel
Treatments tested in this trial
INTELLiVENT-ASV.
DeviceINTELLiVENT-ASV® is a closed-loop ventilation mode that automatically adjusts respiratory rate and tidal volume according to the oxygen and ventilatory patient needs
Treatment groups
328 Participants
are divided into 2 treatment groupsGroup A: INTELLiVENT-ASVOther 1 intervention
Group B: conventional ventilationNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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
1
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 hours2
Duration of postoperative ventilation
The time from admission on the ICU until extubation.
Time frame
8 hours or until extubation3
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 time4
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%.
Time frame
Up to 6 hours of mechanical ventilation timeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Medical University of Vienna
Lead sponsor
University Hospital Dubrava
Collaborator
Università degli Studi dell'Insubria
Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborator
University of Zurich
Collaborator
Source ClinicalTrials.gov