Ventilation With ASV Mode in Children

Study Overview
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Brief Summary
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ASV mode of ventilation is an automatic mode with closed-loop control used for mechanical invasive ventilation in intubated patients. It has been studied in adult patients but not in children. This interventional physiology study will include 40 children on mechanical invasive ventilation.

Detailed Description
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The objective of the study is to assess the feasibility of ASV in children and compare physiologic values on ASV mode to Pressure-Control and Pressure-Support mode of ventilation regarding the participant is on active or passive ventilation phase. Physiologic values will be monitored on different modes of ventilation in a randomized order. Each participant will be his own control regarding the different modes of ventilation. Monitoring will be done during 90 minutes for each mode of ventilation. Participant will have two different phases of ventilation. The first one is the passive phase (participant does not trigger the ventilator cycle sustainly) in which ASV and Pressure-Control Ventilation will be performed in a randomized order. The second phase will be the active ventilation phase (participant does trigger the ventilator cycle sustainly) in which ASV and Pressure-Support Ventilation will be performed in a randomized order.

Official Title
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Monocentric Interventional Study on the Feasibility of the Invasive Mechanical Ventilation Mode Adaptive Support Ventilation, ASV in a Pediatric Population and Comparison to Pressure-Control and Pressure-Support Ventilation Modes

Conditions
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Mechanical Ventilation

Intervention / Treatment
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* Procedure: ASV ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children on invasive mechanical ventilation admitted in the Pediatric Intensive Care Unit at Lausanne University Hospital Body weight > 6kg Absence of pulmonary comorbidity Age < 10 years Exclusion Criteria: Patient already included in other interventional clinical study body weight < 6kg age > 10 years more than 20% of air leak around endotracheal tube chronic or acute pulmonary disease (ARDS, cystic fibrosis, severe asthma, lobectomy, severe bronchomalacia or severe tracheomalacia) severe pulmonary hypertension on inhaled nitric oxide treatment severe hemodynamic instability (more than 0.5mcg/kg/min of norepinephrine infusion or other high dose vasoactive agent infusion) intracranial hypertension (more than 20mmHg if measured) or suspected intracranial hypertension

Ages Eligible for Study
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Maximum Age: 10 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Two different phases of ventilation (passive versus active) will be monitored in each patient. In each phase, two different modes of ventilation will be performed in a randomized order and will be monitored (Pressure-Control Ventilation and ASV during the passive ventilation phase, Pressure-Support Ventilation and ASV during the active ventilation phase). Washout periods will be performed between the different modes of ventilation.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Passive phase, Pressure-Control Ventilation / ASV order<br>90 minutes of Pressure-Control Ventilation, change to ASV mode with 15 to 30 minutes of washout, 90 minutes of ASV. Return to Pressure-Control Ventilation mode at the end of the intervention. | Procedure: ASV ventilation<br>* Ventilation on ASV mode<br>|
| Experimental: Passive phase, ASV / Pressure-Control Ventilation order<br>90 minutes of ASV, change to Pressure-Control Ventilation mode with 15 to 30 minutes of washout, 90 minutes of Pressure-Control Ventilation. | Procedure: ASV ventilation<br>* Ventilation on ASV mode<br>|
| Experimental: Active phase, Pressure-Support / ASV order<br>90 minutes of Pressure-Support Ventilation, change to ASV mode with 15 to 30 minutes of washout, 90 minutes of ASV. Return to Pressure-Support Ventilation at the end of the intervention. | Procedure: ASV ventilation<br>* Ventilation on ASV mode<br>|
| Experimental: Active phase, ASV / Pressure-Support order<br>90 minutes of ASV, change to Pressure-Support Ventilation with 15 to 30 minutes of washout, 90 minutes of Pressure-Support Ventilation. | Procedure: ASV ventilation<br>* Ventilation on ASV mode<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of respiratory rate | Physiological respiratory value of mechanical ventilation | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | 
| Change of tidal volume | Physiological respiratory value of mechanical ventilation | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | 
| Change of peak inspiratory pressure | Physiological respiratory value of mechanical ventilation | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of Minute Ventilation | Physiological respiratory value of mechanical ventilation | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | 
| Evolution of Mean airway pressure | Physiological respiratory value of mechanical ventilation | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | 
| Evolution of inspiratory time | Physiological respiratory value of mechanical ventilation | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | 
| Evolution of ratio inspiratory time/expiratory time | Physiological respiratory value of mechanical ventilation | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | 
| Evolution of Crs (respiratory system compliance calculated by the ventilator) | Physiological respiratory value of mechanical ventilation | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | 
| Evolution of respiratory system resistance | Physiological respiratory value of mechanical ventilation | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | 
| Evolution of respiratory system time constant | Physiological respiratory value of mechanical ventilation | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | 
| Evolution of positive end expiratory pressure (PEEP) | Physiological respiratory value of mechanical ventilation | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | 
| Evolution of the variation of respiratory rate | Physiological respiratory value of mechanical ventilation | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | 
| Evolution of the variation of peak inspiratory pressure | Physiological respiratory value of mechanical ventilation | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | 
| Evolution of end-tidal CO2 | Physiological respiratory value of mechanical ventilation | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | 
| Evolution of the variation of end-tidal CO2 | Physiological respiratory value of mechanical ventilation | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | 
| Evolution of transcutaneous CO2 | Physiological respiratory value of mechanical ventilation | Recording every 5 minutes during each monitoring phase of 90 minutes, 360 minutes | 
| Evolution of variation of transcutaneous CO2 | Physiological respiratory value of mechanical ventilation | Recording every 5 minutes during each monitoring phase of 90 minutes, 360 minutes | 
| Evolution of inspired oxygen fraction | Physiological respiratory value of mechanical ventilation | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | 
| Evolution of variation of inspired oxygen fraction | Physiological respiratory value of mechanical ventilation | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | 
| Evolution of transcutaneous oxygen saturation | Physiological respiratory value of mechanical ventilation | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | 
| Evolution of variation of transcutaneous oxygen saturation | Physiological respiratory value of mechanical ventilation | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | 
| Evolution of the work load of mechanical ventilation for doctor | Recording of all modification done on ventilator parameters done by doctor during each monitoring phase | monitoring phase of 90 minutes | 
| Evolution of mechanical ventilation tolerance | Recording of all sedation drugs administered to the participant during each monitoring phase | monitoring phase of 90 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, Ventilation, Closed-loop mechanical ventilation, Adaptive support ventilation