Clinical trial NCT03930147: Ventilation With ASV Mode in Children
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation
Keywords: Children
Ventilation
Closed-loop mechanical ventilation
Adaptive support ventilation
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2019-04-29
Enrollment: 40
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of respiratory rate
timeFrame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
measure: Change of tidal volume
timeFrame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
measure: Change of peak inspiratory pressure
timeFrame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Secondary outcomes:
measure: Evolution of Minute Ventilation
timeFrame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
measure: Evolution of Mean airway pressure
timeFrame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
measure: Evolution of inspiratory time
timeFrame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
measure: Evolution of ratio inspiratory time/expiratory time
timeFrame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
measure: Evolution of Crs (respiratory system compliance calculated by the ventilator)
timeFrame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
measure: Evolution of respiratory system resistance
timeFrame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
measure: Evolution of respiratory system time constant
timeFrame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
measure: Evolution of positive end expiratory pressure (PEEP)
timeFrame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
measure: Evolution of the variation of respiratory rate
timeFrame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
measure: Evolution of the variation of peak inspiratory pressure
timeFrame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
measure: Evolution of end-tidal CO2
timeFrame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
measure: Evolution of the variation of end-tidal CO2
timeFrame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
measure: Evolution of transcutaneous CO2
timeFrame: Recording every 5 minutes during each monitoring phase of 90 minutes, 360 minutes
measure: Evolution of variation of transcutaneous CO2
timeFrame: Recording every 5 minutes during each monitoring phase of 90 minutes, 360 minutes
measure: Evolution of inspired oxygen fraction
timeFrame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
measure: Evolution of variation of inspired oxygen fraction
timeFrame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
measure: Evolution of transcutaneous oxygen saturation
timeFrame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
measure: Evolution of variation of transcutaneous oxygen saturation
timeFrame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes
measure: Evolution of the work load of mechanical ventilation for doctor
timeFrame: monitoring phase of 90 minutes
measure: Evolution of mechanical ventilation tolerance
timeFrame: monitoring phase of 90 minutes
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Lausanne University Hospital
Study officials:
affiliation: University of Lausanne Hospitals
name: Thomas Ferry, MD
role: PRINCIPAL_INVESTIGATOR
References: