Pilot Evaluation of Closed Loop Ventilation and Oxygen Controller

Study Overview
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Brief Summary
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The study compares automated settings (Intellivent) with protocolized settings of the ventilator after cardiac surgery. The settings concern the respiratory rate, the inspiratory and expiratory pressure and FiO2. The aim of the study is to demonstrate that automated settings are feasible and safe. The study design is a randomized controled study. 30 patients will be ventilated with automated mode and 30 patients with protocolized settings after cardiac surgery. The hypothesis is that the automated mode allows a safer ventilation with better maintain of the patient in predefined optimal zone of ventilation.

Detailed Description
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Aim: feasibility and safety study = evaluation of the possibility for a fully automated ventilator to safely manage the ventilation and oxygenation after cardiac surgery Hypothesis: Intellivent will maintain the patient with  optimal ventilation  better than during usual management with a minimal number of interventions Monocentric: IUCPQ, Hôpital Laval, Québec Randomized controlled safety study, unblinded Patients after elective cardiac surgery Two arms Intellivent (fully automatic ventilation) Protocolized ventilation 4 hours study 60 patients planned to be included Primary outcome: number of episodes in the  not acceptable  zone of ventilation and duration Secondary outcome: Number of episodes in the  acceptable  zone of ventilation and duration Number of manual settings and duration of interventions Comparison of arterial blood gases Time to wean the FiO2 the PEEP Time to begin the assisted ventilation Duration of mechanical ventilation

Official Title
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Pilot Evaluation of Closed Loop Ventilation and Oxygen Controller

Conditions
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Cardiac Surgery, Mechanically Ventilated Patients

Intervention / Treatment
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* Device: Hamilton ventilator (G5 modify to S1) Automated settings
* Other: Hamilton ventilator (G5) protocolized settings


Participation Criteria
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Eligibility Criteria
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Criteria for consent (before surgical procedure): Elective cardiac surgery Age 18 to 90 years Absence of pregnancy Body Mass Index < 40 kg/m² Creatinine < 200micromol/L) Baseline PaCO2 > 50 mmHg) Exclusion Criteria: Unexpected surgical procedure Major complication during surgery Early extubation expected (< 1 hour) Broncho-pleural fistula Study ventilator not available

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Automated settings<br>Ventilator settings automatically adjusted by the evaluated system, concerning the FiO2, the respiratory rate, the inspiratory and expiratory pressures and related settings (triggers, pressurization ramp, inspiratory/expiratory time...) | Device: Hamilton ventilator (G5 modify to S1) Automated settings<br>* Automated settings (respiratory rate [RR], FiO2, Insp and exp pressures) Ventilator settings automatically adjusted by the evaluated system, concerning the FiO2, the respiratory rate, the inspiratory and expiratory pressures and related settings (triggers, pressurization ramp, inspiratory/expiratory time...)<br>* Other names: Intellivent;|
| Active Comparator: protocolized settings<br>Ventilator settings performed by the local respiratory therapists according to the local protocols | Other: Hamilton ventilator (G5) protocolized settings<br>* Mechanical ventilation settings performed by the respiratory therapists according to the local protocols<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
|  not acceptable  zone of ventilation | Number of episodes, duration and percentage of time in the  not acceptable  zone of ventilation as pre-defined | During the four hours of the study protocol | 
|  not acceptable  zone of ventilation | Number of episodes, duration and percentage of time in the  not acceptable  zone of ventilation as pre-defined | During the 4 hours of the protocol | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac surgery, mechanical ventilation, automation, weaning