Menu
Recruiting NCT06178510

I-ASV in Cardiac Surgery

No phase Interventional Ventilator Lung

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: INTELLiVENT-ASV..
Who it may be relevant to
Registry conditions: Ventilator Lung. Basic parameters: 18 years — 120 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

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

  • Device INTELLiVENT-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

Primary outcome measures

  • Quality of ventilation [Time frame: During the first 2 hours, since admission on the ICU with the start of the intervention ventilation mode.]
Secondary outcome measures (7)
  • ICU nursing staff workload [Time frame: 24 hours]
  • Duration of postoperative ventilation [Time frame: 8 hours or until extubation]
  • Patient-ventilator asynchrony [Time frame: Up to 6 hours of mechanical ventilation time]
  • Proportion of breath spent in zones of ventilation [Time frame: Up to 6 hours of mechanical ventilation time]
  • ICU length of stay [Time frame: From date of ICU admission until the date of ICU discharge, assessed up to 30 days]
  • Hospital length of stay [Time frame: From date of hospital admission until the date of hospital discharge, assessed up to 30 days]
  • Mortality [Time frame: 28-day]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Other

Study locations

Austria · 1 center
  • Medical University of Vienna — Vienna

Publications

  • Bernardi MH, Bettex D, Buiteman-Kruizinga LA, de Bie A, Hoffmann M, de Kleijn J, Serafini SC, Molenaar MA, Paulus F, Persec J, Neto AS, Schuepbach R, Severgnini P, Sribar A, Schultz MJ, Tschernko E; POSITiVE II-investigators. POStoperative INTELLiVENT-adaptive support VEntilation in cardiac surgery patients (POSITiVE) II-study protocol of a randomized clinical trial. Trials. 2024 Jul 3;25(1):449. PMID 38961468

Identifiers

NCT: NCT06178510 · POSITiVE II v1.1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗