I-ASV in Cardiac Surgery

NCT06178510 | Recruiting DMC

• 1 other identifier: POSITiVE II v1.1
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator Lung

Keywords

Adaptative Support Ventilation; INTELLiVENT; Cardiac Surgery; Workload

Outcome Measures

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%.

  During the first 2 hours, since admission on the ICU with the start of the intervention ventilation mode.

Secondary Outcomes (7)

• ICU nursing staff workload

  24 hours

• Duration of postoperative ventilation

  8 hours or until extubation

• Patient-ventilator asynchrony

  Up to 6 hours of mechanical ventilation time

• Proportion of breath spent in zones of ventilation

  Up to 6 hours of mechanical ventilation time

• ICU length of stay

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

Study Arms (2)

INTELLiVENT-ASV

OTHER

The ventilator set parameters such as tidal volume, respiratory rate, and positive end-expiratory pressure to ensure adequate ventilation and oxygenation. The investigators monitor it and define clinical target.

Device: INTELLiVENT-ASV.

conventional ventilation

NO INTERVENTION

The investigators set and monitor parameters such as tidal volume, respiratory rate, and positive end-expiratory pressure to ensure adequate ventilation and oxygenation.

Interventions

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

INTELLiVENT-ASV

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. aged \> 18 years of age;
• \. scheduled for elective cardiac surgery; and
• \. expected to receive postoperative ventilation in the ICU for \> 2 hours.

You may not qualify if:

• 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:

Sponsors & Collaborators

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

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, A-1090, Austria

RECRUITING

Related Publications (1)

• 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. doi: 10.1186/s13063-024-08296-2.

  PMID: 38961468 DERIVED

Study Officials

• Edda Tschernko, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edda Tschernko, MD

CONTACT

00 43 1 40400 41090; edda.tschernko@meduniwien.ac.at

Martin H. Bernardi, MD

CONTACT

00 43 1 40400 41090; martin.bernardi@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 21, 2023
• Study Start: May 31, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 4, 2024

Record last verified: 2024-10

Locations

AU (1)