S4 :Trial Of Fully Closed-Loop Ventilation In ICU.

Study Overview
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Brief Summary
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Preliminary study to compare IntelliVent-ASV to conventional modes used from intubation to extubation or death in ICU patients requiring mechanical ventilation measuring duration of mechanical ventilation in order to design a multicenter large trial.

Official Title
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S4 :RANDOMIZED CONTROLLED TRIAL OF FULLY CLOSED-LOOP VENTILATION IN ICU.

Conditions
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Intensive Care Patients Invasively Ventilated

Intervention / Treatment
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* Device: INTELLIVENT ASV FULLY CLOSED-LOOP VENTILATION
* Device: Conventionals Modes


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: - Unselected ICU patients invasively ventilated for less than 24 hours, with an expected duration of MV longer than 48 hours. Exclusion criteria: broncho-pleural fistula dyshemoglobulinémia moribund patient do-not-resuscitate order chronic respiratory failure requiring long term ventilation, patient ventilated more than 24 hours before admission, pregnancy, age below 18 years, protected patients, patient already participating in the study, Cheynes-Stockes breathing. Included patients with a treatment withdrawal decision within 24 hours after inclusion will be excluded, patients transferred to another ICU, patients needing ECMO, patients randomized to IntelliVent having less than 20% of time in IntelliVent-ASV.

Ages Eligible for Study
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Minimum Age: 18 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FULLY CLOSED-LOOP VENTILATION<br>IntelliVent-ASV automatic mode | Device: INTELLIVENT ASV FULLY CLOSED-LOOP VENTILATION<br> <br> |
| Active Comparator: Conventional modes ventilation<br>Conventional modes | Device: Conventionals Modes<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numbers of manual adjustments | Numbers of manual adjustments of the FULLY CLOSED-LOOP VENTILATION device ( INTELLIVENT ASV) | participants are followed until they no longer need ventilation, up to 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sedation duration, |  | participants are followed until they no longer need ventilation, up to 10 days | 
| ventilation parameters |  | participants are followed until they no longer need ventilation, up to 10 days | 
| Sedation doses |  | participants are followed until they no longer need ventilation, up to 10 days | 
| Duration of invasive ventilation |  | participants are followed until they no longer need ventilation, up to 10 days | 
| ICU Mortality |  | participants are followed until they no longer need ventilation, up to 10 days | 
| 28 days mortality |  | participants are followed until they no longer need ventilation, up to 10 days |