Ventilation With ASV Mode in Children

Mechanical Ventilation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03930147
• Other study ID #: ASV ventilation in children
• Status: Completed
• Phase: N/A
• Start date: September 13, 2019
• Est. completion date: December 5, 2023

Study information

• Verified date: December 2023
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 5, 2023
• Est. primary completion date: December 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Mechanical Ventilation

Intervention

Procedure:
• ASV ventilation
Ventilation on ASV mode

Locations

Country	Name	City	State
Switzerland	Lausanne University Hospital	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of respiratory rate	Physiological respiratory value of mechanical ventilation	Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Primary	Change of tidal volume	Physiological respiratory value of mechanical ventilation	Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Primary	Change of peak inspiratory pressure	Physiological respiratory value of mechanical ventilation	Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Secondary	Evolution of Minute Ventilation	Physiological respiratory value of mechanical ventilation	Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Secondary	Evolution of Mean airway pressure	Physiological respiratory value of mechanical ventilation	Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Secondary	Evolution of inspiratory time	Physiological respiratory value of mechanical ventilation	Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Secondary	Evolution of ratio inspiratory time/expiratory time	Physiological respiratory value of mechanical ventilation	Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Secondary	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
Secondary	Evolution of respiratory system resistance	Physiological respiratory value of mechanical ventilation	Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Secondary	Evolution of respiratory system time constant	Physiological respiratory value of mechanical ventilation	Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Secondary	Evolution of positive end expiratory pressure (PEEP)	Physiological respiratory value of mechanical ventilation	Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Secondary	Evolution of the variation of respiratory rate	Physiological respiratory value of mechanical ventilation	Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Secondary	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
Secondary	Evolution of end-tidal CO2	Physiological respiratory value of mechanical ventilation	Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Secondary	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
Secondary	Evolution of transcutaneous CO2	Physiological respiratory value of mechanical ventilation	Recording every 5 minutes during each monitoring phase of 90 minutes, 360 minutes
Secondary	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
Secondary	Evolution of inspired oxygen fraction	Physiological respiratory value of mechanical ventilation	Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Secondary	Evolution of variation of inspired oxygen fraction	Physiological respiratory value of mechanical ventilation	Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Secondary	Evolution of transcutaneous oxygen saturation	Physiological respiratory value of mechanical ventilation	Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Secondary	Evolution of variation of transcutaneous oxygen saturation	Physiological respiratory value of mechanical ventilation	Continuous recording during each monitoring phase of 90 minutes, 360 minutes
Secondary	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
Secondary	Evolution of mechanical ventilation tolerance	Recording of all sedation drugs administered to the participant during each monitoring phase	monitoring phase of 90 minutes