Medical University of Vienna
Vienna, State of Vienna, A-1090, Austria
Location status: Recruiting
Location contact
Edda Tschernko, MD
CONTACT
Martin H Bernardi, MD, PhD
CONTACT
Martin H Bernardi, MD, PhD
CONTACT
NCT Number: NCT06178510
'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.
Interested in participating?
Request Info18 year–120 year
All sexes
Interventional
Not applicable
Vienna, State of Vienna, A-1090, Austria
Location status: Recruiting
Edda Tschernko, MD
CONTACT
Martin H Bernardi, MD, PhD
CONTACT
Martin H Bernardi, MD, PhD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
At the end of surgery, patients are additionally excluded if a patient:
INTELLiVENT-ASV® is a closed-loop ventilation mode that automatically adjusts respiratory rate and tidal volume according to the oxygen and ventilatory patient needs
Time frame: 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.
Time frame: 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
Time frame: 8 hours or until extubation
The time from admission on the ICU until extubation.
Time frame: Up to 6 hours of mechanical ventilation time
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 breaths spent in predefined and previously used zones of ventilation in the first 6 hours of postoperative ventilation.
Time frame: From date of ICU admission until the date of ICU discharge, assessed up to 30 days
Length of stay in the ICU
Time frame: From date of hospital admission until the date of hospital discharge, assessed up to 30 days
Length of stay in hospital
Time frame: 28-day
Mortality in ICU or hospital
Contact information is provided by the study sponsor or research team.
Edda Tschernko, MD
CONTACT
Martin H. Bernardi, MD
CONTACT
Medical University of Vienna
Other
POStoperative INTELLiVENT-adaptive Support VEntilation in Cardiac Surgery Patients II (POSITiVE II) - a Randomized Clinical Trial
Acronym: POSITiVE II
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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