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Ventilation With ASV Mode in Children

L

Lausanne University Hospital (CHUV)

Status

Completed

Conditions

Mechanical Ventilation

Treatments

Procedure: ASV ventilation

Study type

Interventional

Funder types

Other

Identifiers

NCT03930147
ASV ventilation in children

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

Under 10 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

40 participants in 4 patient groups

Passive phase, Pressure-Control Ventilation / ASV order
Experimental group
Description:
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.
Treatment:
Procedure: ASV ventilation
Passive phase, ASV / Pressure-Control Ventilation order
Experimental group
Description:
90 minutes of ASV, change to Pressure-Control Ventilation mode with 15 to 30 minutes of washout, 90 minutes of Pressure-Control Ventilation.
Treatment:
Procedure: ASV ventilation
Active phase, Pressure-Support / ASV order
Experimental group
Description:
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.
Treatment:
Procedure: ASV ventilation
Active phase, ASV / Pressure-Support order
Experimental group
Description:
90 minutes of ASV, change to Pressure-Support Ventilation with 15 to 30 minutes of washout, 90 minutes of Pressure-Support Ventilation.
Treatment:
Procedure: ASV ventilation

Trial contacts and locations

1

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Central trial contact

Marie-Helene Perez, MD; Thomas Ferry, MD

Data sourced from clinicaltrials.gov

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