I-ASV in Cardiac Surgery (POSITiVE II)

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

Study Overview

• Status: Recruiting
• Conditions: Ventilator Lung
• Intervention / Treatment: Device: INTELLiVENT-ASV.

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.

• Study Type: Interventional
• Enrollment (Estimated): 328
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Edda Tschernko, MD; Phone Number: 00 43 1 40400 41090; Email: edda.tschernko@meduniwien.ac.at
• Study Contact Backup: Name: Martin H. Bernardi, MD; Phone Number: 00 43 1 40400 41090; Email: martin.bernardi@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, A-1090
    • Recruiting
    • Medical University of Vienna
    • Contact: Martin H Bernardi, MD, PhD; Phone Number: 004314040041090; Email: martin.bernardi@meduniwien.ac.at
    • Contact: Martin H Bernardi, MD, PhD
    • Contact: Edda Tschernko, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

1. any emergency or semi-elective surgery (precluding informed written consent);
2. 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);
3. enrolled in another interventional trail;
4. no written informed consent obtained;
5. history of recent pneumectomy or lobectomy;
6. history of COPD with oxygen at home;
7. body mass index > 35;
8. preoperative forced expiratory volume in the first second (FeV1)/forced vital capacity (VC) < 50% (if available);
9. preoperative arterial oxygen partial pressure (PaO2) < 60 mm Hg (at room air);
10. preoperative arterial carbon dioxide partial pressure (PaCO2) > 50 mm Hg;
11. preoperative left ventricular ejection fraction < 30% (if available);
12. preoperative systolic pulmonary artery pressure > 60 mm Hg (if available);
13. preoperative left ventricular mechanical support, e.g., Impella®; or

14. preoperative use of veno-venous or veno-arterial extracorporeal support

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: INTELLiVENT-ASV; 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.; INTELLiVENT-ASV® is a closed-loop ventilation mode that automatically adjusts respiratory rate and tidal volume according to the oxygen and ventilatory patient needs
No Intervention: conventional ventilation; The investigators set and monitor parameters such as tidal volume, respiratory rate, and positive end-expiratory pressure to ensure adequate ventilation and oxygenation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 hours
Duration of postoperative ventilation	The time from admission on the ICU until extubation.	8 hours or until extubation
Patient-ventilator asynchrony	patient-ventilator asynchrony requiring deepening of sedation and/or administration of muscle relaxants	Up to 6 hours of mechanical ventilation time
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%.	Up to 6 hours of mechanical ventilation time
ICU length of stay	Length of stay in the ICU	From date of ICU admission until the date of ICU discharge, assessed up to 30 days
Hospital length of stay	Length of stay in hospital	From date of hospital admission until the date of hospital discharge, assessed up to 30 days
Mortality	Mortality in ICU or hospital	28-day

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: University of Zurich; Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); University Hospital Dubrava; Università degli Studi dell'Insubria
• Investigators: Principal Investigator: Edda Tschernko, MD, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 4, 2023
• First Submitted That Met QC Criteria: December 20, 2023
• First Posted (Actual): December 21, 2023

Study Record Updates

• Last Update Posted (Estimated): November 4, 2024
• Last Update Submitted That Met QC Criteria: October 31, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Cardiac Surgery; Workload; Adaptative Support Ventilation; INTELLiVENT
• Other Study ID Numbers: POSITiVE II v1.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

The results of the study will find their way into (inter-) national scientific journals and guidelines.

We will submit a summary of results to scientific journals in the field of anesthesiology.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No