Mechanical Ventilation
Conditions
Keywords
Children, Ventilation, Closed-loop mechanical ventilation, Adaptive support ventilation
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.
Interventions
PROCEDUREASV ventilation
Ventilation on ASV mode
Sponsors
University of Lausanne Hospitals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
No minimum to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of respiratory rate | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | Physiological respiratory value of mechanical ventilation |
| Change of tidal volume | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | Physiological respiratory value of mechanical ventilation |
| Change of peak inspiratory pressure | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | Physiological respiratory value of mechanical ventilation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of ratio inspiratory time/expiratory time | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | Physiological respiratory value of mechanical ventilation |
| Evolution of Crs (respiratory system compliance calculated by the ventilator) | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | Physiological respiratory value of mechanical ventilation |
| Evolution of respiratory system resistance | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | Physiological respiratory value of mechanical ventilation |
| Evolution of respiratory system time constant | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | Physiological respiratory value of mechanical ventilation |
| Evolution of positive end expiratory pressure (PEEP) | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | Physiological respiratory value of mechanical ventilation |
| Evolution of the variation of respiratory rate | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | Physiological respiratory value of mechanical ventilation |
| Evolution of the variation of peak inspiratory pressure | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | Physiological respiratory value of mechanical ventilation |
| Evolution of end-tidal CO2 | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | Physiological respiratory value of mechanical ventilation |
| Evolution of Minute Ventilation | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | Physiological respiratory value of mechanical ventilation |
| Evolution of transcutaneous CO2 | Recording every 5 minutes during each monitoring phase of 90 minutes, 360 minutes | Physiological respiratory value of mechanical ventilation |
| Evolution of variation of transcutaneous CO2 | Recording every 5 minutes during each monitoring phase of 90 minutes, 360 minutes | Physiological respiratory value of mechanical ventilation |
| Evolution of inspired oxygen fraction | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | Physiological respiratory value of mechanical ventilation |
| Evolution of variation of inspired oxygen fraction | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | Physiological respiratory value of mechanical ventilation |
| Evolution of transcutaneous oxygen saturation | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | Physiological respiratory value of mechanical ventilation |
| Evolution of variation of transcutaneous oxygen saturation | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | Physiological respiratory value of mechanical ventilation |
| Evolution of the work load of mechanical ventilation for doctor | monitoring phase of 90 minutes | Recording of all modification done on ventilator parameters done by doctor during each monitoring phase |
| Evolution of mechanical ventilation tolerance | monitoring phase of 90 minutes | Recording of all sedation drugs administered to the participant during each monitoring phase |
| Evolution of the variation of end-tidal CO2 | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | Physiological respiratory value of mechanical ventilation |
| Evolution of Mean airway pressure | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | Physiological respiratory value of mechanical ventilation |
| Evolution of inspiratory time | Continuous recording during each monitoring phase of 90 minutes, 360 minutes | Physiological respiratory value of mechanical ventilation |
Countries
Switzerland
Outcome results
None listed