Ventilation With ASV Mode in Children

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

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.

Study Overview

• Status: Completed
• Conditions: Mechanical Ventilation
• Intervention / Treatment: Procedure: ASV 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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas Ferry, MD; Phone Number: +41795563626; Email: thomas.ferry@chuv.ch
• Study Contact Backup: Name: Marie-Helene Perez, MD; Phone Number: +41795564082; Email: marie-helene.perez@chuv.ch

Study Locations

• Switzerland
  • Lausanne, Switzerland, 1011
    • Lausanne University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 10 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
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: 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: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Lausanne Hospitals
• Investigators: Principal Investigator: Thomas Ferry, MD, Lausanne University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2019
• Primary Completion (Actual): December 5, 2023
• Study Completion (Actual): December 5, 2023

Study Registration Dates

• First Submitted: April 12, 2019
• First Submitted That Met QC Criteria: April 25, 2019
• First Posted (Actual): April 29, 2019

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Children; Ventilation; Closed-loop mechanical ventilation; Adaptive support ventilation
• Other Study ID Numbers: ASV ventilation in children

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No