I-ASV in Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

328 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-31

Study Completion Date

2025-12-31

Brief Summary

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'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.

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Detailed Description

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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.

Conditions

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Ventilator Lung

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type OTHER

INTELLiVENT-ASV.

Intervention Type 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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No