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Recruiting

NCT Number: NCT06178510

I-ASV in Cardiac Surgery

'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.

Recruiting

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Key information

Conditions

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

[email protected]

004314040041090

Martin H Bernardi, MD, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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;
  • history of recent pneumectomy or lobectomy;
  • history of COPD with oxygen at home;
  • body mass index > 35;
  • preoperative forced expiratory volume in the first second (FeV1)/forced vital capacity (VC) < 50% (if available);
  • preoperative arterial oxygen partial pressure (PaO2) < 60 mm Hg (at room air);
  • preoperative arterial carbon dioxide partial pressure (PaCO2) > 50 mm Hg;
  • preoperative left ventricular ejection fraction < 30% (if available);
  • preoperative systolic pulmonary artery pressure > 60 mm Hg (if available);
  • preoperative left ventricular mechanical support, e.g., Impella®; or
  • preoperative use of veno-venous or veno-arterial extracorporeal support

At the end of surgery, patients are additionally excluded if a patient:

  • cannot be weaned from the extracorporeal support; or
  • unexpectedly needs implementation of an assist device

Treatment and study plan

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

Primary outcomes

  1. Quality of ventilation

    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.

    • 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 outcomes

  1. ICU nursing staff workload

    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

  2. Duration of postoperative ventilation

    Time frame: 8 hours or until extubation

    The time from admission on the ICU until extubation.

  3. Patient-ventilator asynchrony

    Time frame: Up to 6 hours of mechanical ventilation time

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

  4. Proportion of breath spent in zones of ventilation

    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.

    • 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%.
  5. ICU length of stay

    Time frame: From date of ICU admission until the date of ICU discharge, assessed up to 30 days

    Length of stay in the ICU

  6. Hospital length of stay

    Time frame: From date of hospital admission until the date of hospital discharge, assessed up to 30 days

    Length of stay in hospital

  7. Mortality

    Time frame: 28-day

    Mortality in ICU or hospital

Study contacts

Contact information is provided by the study sponsor or research team.

Edda Tschernko, MD

CONTACT

[email protected]

00 43 1 40400 41090

Martin H. Bernardi, MD

CONTACT

[email protected]

00 43 1 40400 41090

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • University Hospital Dubrava
  • University of Zurich
  • Università degli Studi dell'Insubria

Registry information

Official study title

POStoperative INTELLiVENT-adaptive Support VEntilation in Cardiac Surgery Patients II (POSITiVE II) - a Randomized Clinical Trial

Acronym: POSITiVE II

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 21, 2023
Registry last updated
Nov 4, 2024

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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