The Effect of Closed-Loop Versus Conventional Ventilation on Mechanical Power

Study Overview
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Brief Summary
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Several studies suggest fully-automated ventilation to ventilate with a lower amount of MP in unselected ICU patients, patients after cardiac surgery, and patients with and without ARDS. The current study will directly compare the amount of MP in invasively ventilated critically ill patients by calculating MP breath-by-breath, using the various equations proposed in the literature.

Detailed Description
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Rationale: Mechanical ventilation can cause ventilator-induced lung injury (VILI). Lung protective ventilation, consisting of a low tidal volume (VT), a low plateau pressure (Pplateau) and a low driving pressure (ΔP) improves survival and shortens duration of ventilation in patients with acute respiratory distress syndrome (ARDS). Lung protective ventilation may also benefit critically ill patients with respiratory failure not caused by ARDS. 'Mechanical Power of ventilation' (MP), the amount of energy per time transferred from the ventilator to the respiratory system, is a summary variable that includes all the components that play a role in VILI. With fully-automated closed-loop ventilation, these components are no longer set by the operator, but under control of the algorithms in the ventilator. Objective: To compare MP under INTELLiVENT-adaptive support ventilation (ASV), a fully-automated closed-loop ventilation, with MP under conventional ventilation. Hypothesis: INTELLiVENT-ASV compared to conventional ventilation results in a lower MP. Study design: National, multicenter, crossover, randomized clinical trial. Study population: Invasively ventilated critically ill patients. Methods: The ventilator will be randomly switched between INTELLiVENT-ASV for 3 hours and conventional ventilation for 3 hours. The amount of MP is calculated using various equations proposed in the literature. Study endpoints: The primary endpoint is the amount of MP with each form of invasive ventilation. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Differences in burden and risks of the two ventilation strategies compared in the current study are not expected. Both modes of ventilation are interchangeably used as part of standard care in the participating centers. No other interventions are performed. Neither the collection of demographic and outcome data, nor the capturing of ventilation characteristics causes harm to patients.

Official Title
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The Effect of Closed-Loop Versus Conventional Ventilation on Mechanical Power - a Multicenter Crossover Randomized Clinical Trial

Conditions
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Mechanical Ventilation, Mechanical Power

Intervention / Treatment
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* Procedure: Procedure: INTELLiVENT-ASV
* Procedure: Procedure: Conventional ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admitted to one of the participating ICUs; Receiving invasive ventilation through a standard endotracheal (i.e., oral) tube; Expected to be ventilated > 24 hours; and Ventilation is applied by a ventilator that can provide INTELLiVENT-ASV and conventional ventilation. Exclusion Criteria: Age under 18 years; No written informed consent; Morbidly obese; and Any contra-indication for use of 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INTELLiVENT-ASV<br>Use of INTELLiVENT-ASV during 3 hours with 30 minutes wash-out time before. | Procedure: Procedure: INTELLiVENT-ASV<br>* With INTELLiVENT-ASV, the patient's conditions, 'ARDS', 'Chronic Hypercapnia' or 'Traumatic Brain Injury' can be chosen, if applicable. The controllers for minute volume, PEEP and FiO2 are all activated, and the target shifts for etCO2 and SpO2 are adjusted, if necessary.<br>|
| Active Comparator: Conventional Ventilation<br>Use of conventional ventilation during 3 hours with 30 minutes wash-out time before. | Procedure: Procedure: Conventional ventilation<br>* With conventional ventilation, the same etCO2 and SpO2 levels are targeted as with INTELLiVENT-ASV, but here the caregiver is fully responsible for choosing the settings.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of MP delivered with each form of invasive ventilation | The amount of MP delivered with INTELLiVENT-ASV and conventional ventilation | 3 hours per ventilation mode | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of ventilation | Duration of ventilation in survivors | first 28 days after start of ventilation | 
| ICU-length and hospital of stay | Length of stay in the intensive care unit and in the hospital | first 28 days after start of ventilation | 
| 28 day-mortality | Any death during ICU-, hospital-stay and within 28 days | first 28 days after start of ventilation | 
| Tidal volume | Tidal volume in ml/kg | 3 hours per ventilation mode | 
| Respiratory rate | Respiratory rate per minute | 3 hours per ventilation mode | 
| Pmax | Maximum airway pressure in cmH2O | 3 hours per ventilation mode | 
| Driving pressure | Difference between end-inspiratory pressure and total Positieve End Expiratory Pressure in cmH2O | 3 hours per ventilation mode |