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Ventilation With ASV Mode in Children

  • Clinicaltrials.gov identifier

    NCT03930147

  • Recruitment Status

    Recruiting

  • First Posted

    April 29, 2019

  • Last update posted

    November 27, 2020

Study Description

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.

  • Condition or Disease:Mechanical Ventilation
  • Intervention/Treatment: Procedure: ASV ventilation
  • Phase: N/A

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.

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 40 participants
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • 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.
  • Masking: None (Open Label) ()
  • Primary Purpose: Other
  • 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
  • Actual Study Start Date: September 2019
  • Estimated Primary Completion Date: July 2022
  • Estimated Study Completion Date: July 2022

Arms and interventions

Arm Intervention/treatment
Experimental: Active phase, ASV / Pressure-Support order
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
Ventilation on ASV mode
Experimental: Active phase, Pressure-Support / ASV order
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
Ventilation on ASV mode
Experimental: Passive phase, ASV / Pressure-Control Ventilation order
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
Ventilation on ASV mode
Experimental: Passive phase, Pressure-Control Ventilation / ASV order
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
Ventilation on ASV mode

Outcome Measures

  • Primary Outcome Measures: 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 Outcome Measures: 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

Eligibility Criteria

  • Ages Eligible for Study: up to 10 / (Birth to 17 years)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

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 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

Contacts and Locations

Contacts

Contact: Thomas Ferry, MD +41795563626 thomas.ferry@chuv.ch

Contact: Marie-Helene Perez, MD +41795564082 marie-helene.perez@chuv.ch

Locations

Switzerland
Lausanne University Hospital
Lausanne

Sponsors and Collaborators

University of Lausanne Hospitals

Investigators

Principal Investigator: Thomas Ferry, MD Lausanne University Hospital

More Information

  • Responsible Party: University of Lausanne Hospitals
  • ClinicalTrials.gov Identifier: NCT03930147 History of Changes
  • Other Study ID Numbers: ASV ventilation in children
  • First Posted: April 29, 2019 Key Record Dates
  • Last Update Posted: November 27, 2020
  • Last Verified: November 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by University of Lausanne Hospitals: Closed-loop mechanical ventilation
    Adaptive support ventilation
    Ventilation
    Children