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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03930147
Other study ID # ASV ventilation in children
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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