A Comparison of Intellivent-ASV Mode With Conventional Modes in Patients With BMI >35

Study Overview
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Brief Summary
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compare effects of intellectual mode (in our case it will be Intellivent - ASV -) with conventional ventilation modes after uncomplicated cardiac surgery in patients with body mass index >35

Detailed Description
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The study includes the comparison of two methods of invasive respiratory support ventilation( conventional ventilation modes and automatic IntelliventASV mode (a fully automated, or closed-loop, ventilation mode that consists of pressure-controlled ventilation or pressure support ventilation depending on a patient's respiratory activity. In fully automated ventilation mode, tidal volume, pressure levels (including PEEP), minute ventilation, and the oxygen fraction in inspired air are controlled solely by the ventilator) after uncomplicated cardiac surgery). It assumes 30 randomized patients:15 patients in two study groups male and female aged 30 to 70 years of age inclusive, with BMI > 35 kg/m2. The study will be randomized, single-center, prospective.

Official Title
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A Prospective Comparison of the Efficacy and Safety of Intellectual Mode of Ventilation (Intellivent-ASV) With Conventional Modes in Cardiac Surgery Patients With Body Mass Index >35

Conditions
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Ventilation Therapy; Complications

Intervention / Treatment
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* Procedure: respiratory support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Age from 30 years to 70 years inclusive elective cardiac surgery which included bypass, valve and ascending aortic surgery, a body mass index of > 35 kg/m2, postoperative treatment with mechanical ventilation, informed consent Exclusion Criteria: • GFI <30 ml/min before surgery, serum aspartate and alanine transaminase concentration greater than 80 U/l before surgery, left ventricular ejection fraction less than 30% before surgery. Postoperative exclusion criteria: chest tube drainage greater than 3 ml/kg/h, reoperation, myocardial infarction, need for high-dose inotropes or vasopressors or intraaortic balloon pump, presence of a bronchopleural fistula and refractory hypoxemia with an arterial oxygen tension to fractional inspired oxygen concentration ratio less than 150 mmHg, perioperative anaphylactic reaction, seizures, stroke, agitation

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: conventional ventilation mode<br>respiratory support after cardiac surgery. Vt < 6 ml/kg PBW, driving pressure < 13 cmH2O | Procedure: respiratory support<br>* respirators for invasive mechanical ventilation<br>|
| Experimental: intelectual mode - Intelivent ASV<br>closed loop mode of mechanical ventilation Vt < 6 ml/kg PBW, driving pressure < 13 cmH2O | Procedure: respiratory support<br>* respirators for invasive mechanical ventilation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with tidal volume in optimal, suboptimal, unoptimal zone | Number of Participants during mechanical ventilation with Tidal volume in optimal zone < 6 ml/kg/Predicted Body Weight ; Tidal volume in suboptimal zone 6-8 ml/kg/Predicted Body Weight Tidal volume in unoptimal zone >8 ml/kg/Predicted Body Weight | During the first 8 hours, since admission on the ICU with the start of the respiratory support | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the physician's workload | accounting number of manual ventilator settings changes made before extubation of trachea | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative care, closed-loop modes, safety