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Completed

NCT Number: NCT03930147

Ventilation With ASV Mode in Children

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.

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Key information

Age range

Up to 10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lausanne University Hospital

Lausanne, 1011, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASV ventilation

Procedure

Ventilation on ASV mode

Primary outcomes

  1. Change of respiratory rate

    Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes

    Physiological respiratory value of mechanical ventilation

  2. Change of tidal volume

    Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes

    Physiological respiratory value of mechanical ventilation

  3. Change of peak inspiratory pressure

    Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes

    Physiological respiratory value of mechanical ventilation

Secondary outcomes

  1. Evolution of Minute Ventilation

    Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes

    Physiological respiratory value of mechanical ventilation

  2. Evolution of Mean airway pressure

    Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes

    Physiological respiratory value of mechanical ventilation

  3. Evolution of inspiratory time

    Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes

    Physiological respiratory value of mechanical ventilation

  4. Evolution of ratio inspiratory time/expiratory time

    Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes

    Physiological respiratory value of mechanical ventilation

  5. Evolution of Crs (respiratory system compliance calculated by the ventilator)

    Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes

    Physiological respiratory value of mechanical ventilation

  6. Evolution of respiratory system resistance

    Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes

    Physiological respiratory value of mechanical ventilation

  7. Evolution of respiratory system time constant

    Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes

    Physiological respiratory value of mechanical ventilation

  8. Evolution of positive end expiratory pressure (PEEP)

    Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes

    Physiological respiratory value of mechanical ventilation

  9. Evolution of the variation of respiratory rate

    Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes

    Physiological respiratory value of mechanical ventilation

  10. Evolution of the variation of peak inspiratory pressure

    Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes

    Physiological respiratory value of mechanical ventilation

  11. Evolution of end-tidal CO2

    Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes

    Physiological respiratory value of mechanical ventilation

  12. Evolution of the variation of end-tidal CO2

    Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes

    Physiological respiratory value of mechanical ventilation

  13. Evolution of transcutaneous CO2

    Time frame: Recording every 5 minutes during each monitoring phase of 90 minutes, 360 minutes

    Physiological respiratory value of mechanical ventilation

  14. Evolution of variation of transcutaneous CO2

    Time frame: Recording every 5 minutes during each monitoring phase of 90 minutes, 360 minutes

    Physiological respiratory value of mechanical ventilation

  15. Evolution of inspired oxygen fraction

    Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes

    Physiological respiratory value of mechanical ventilation

  16. Evolution of variation of inspired oxygen fraction

    Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes

    Physiological respiratory value of mechanical ventilation

  17. Evolution of transcutaneous oxygen saturation

    Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes

    Physiological respiratory value of mechanical ventilation

  18. Evolution of variation of transcutaneous oxygen saturation

    Time frame: Continuous recording during each monitoring phase of 90 minutes, 360 minutes

    Physiological respiratory value of mechanical ventilation

  19. Evolution of the work load of mechanical ventilation for doctor

    Time frame: monitoring phase of 90 minutes

    Recording of all modification done on ventilator parameters done by doctor during each monitoring phase

  20. Evolution of mechanical ventilation tolerance

    Time frame: monitoring phase of 90 minutes

    Recording of all sedation drugs administered to the participant during each monitoring phase

Sponsors and collaborators

Lead sponsor

University of Lausanne Hospitals

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Apr 29, 2019
Registry last updated
Dec 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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