Intellivent ASV in Chronic Obstructive Pulmonary Disease Patients in the ICU

Study Overview
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Brief Summary
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This study will evaluate the effect of a fully closed loop ventilation mode (Intellivent ASV) on the duration of ventilation compared to conventional modes in COPD patients.

Detailed Description
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COPD patients often need invasive mechanical ventilation and due to the difficulties in the weaning of these patients, duration of mechanical ventilation can be relatively longer when compared with other ICU patients. Automated systems show promising results in shortening the weaning time in some patient groups. The aim of this study is to evaluate the effect of Intellivent-ASV with Quickwean function on the total duration of invasive mechanical ventilation as a primary outcome. Secondary outcomes are success rate and duration of weaning, ventilator free days at day 28 and intubation free days at day 28 (including NIV) when compared to conventional ventilation with t-piece weaning.

Official Title
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A Randomized Controlled Trial Comparing a Fully Closed Loop Ventilation Mode (Intellivent ASV) With Pressure Controlled + Pressure Support Ventilation in COPD Patients

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: Intellivent ASV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COPD patients intubated and mechanically ventilated for less than 24 hours (Including patients who received NIV before intubation) Age > 18 years Written and/or informed consent Exclusion Criteria: Septic shock Tracheostomy and/or home mechanical ventilation Expected poor short term prognosis Cardiac arrest with a poor neurological prognosis ARDS Broncho-pleural fistula

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intellivent ASV<br>Patients in this arm will be ventilated with Intellivent ASV. Intellivent ASV is an automatic close loop ventilation mode. FiO2 setting will be automatically adjusted according to patients SpO2 and minute volume will be automatically adjusted according to patients EtCO2. | Device: Intellivent ASV<br>* Automated Invasive mechanical ventilation and weaning strategy<br>|
| No Intervention: PCV+PSV<br>PCV+PSV is a conventional ventilation strategy of pressure controlled ventilation PCV) and pressure support ventilation (PSV).In this arm, FiO2, pressure control levels, respiratory frequency and all the ventilator settings will be manually adjusted by the physicians in charge. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of intubation | Time from intubation until extubation | 24th month | 
| Duration of mechanical ventilation (NIV included) | Total time patient remains on mechanical ventilation support (invasive or noninvasive) | 24th month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of manual settings | Number of adjusments made manually to set the ventilator | 24th month | 
| Number of blood gas analysis tests | Number of arterial blood gas tests under mechanical ventilation | 24th month | 
| Weaning duration | Time from the beginning of weaning until extubation | 24th month | 
| Time spent on spontaneous ventilation | Time patient actively triggers the ventilator | 24th month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiration, Artificial, weaning, critical care