Ventilation With ASV Mode in Children

NCT03930147 | Completed DMC

• 1 other identifier: ASV ventilation in children
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation

Keywords

Children; Ventilation; Closed-loop mechanical ventilation; Adaptive support ventilation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (20)

• Evolution of Minute Ventilation

  Continuous recording during each monitoring phase of 90 minutes, 360 minutes

• Evolution of Mean airway pressure

  Continuous recording during each monitoring phase of 90 minutes, 360 minutes

• Evolution of inspiratory time

  Continuous recording during each monitoring phase of 90 minutes, 360 minutes

• Evolution of ratio inspiratory time/expiratory time

  Continuous recording during each monitoring phase of 90 minutes, 360 minutes

• Evolution of Crs (respiratory system compliance calculated by the ventilator)

  Continuous recording during each monitoring phase of 90 minutes, 360 minutes

Study Arms (4)

Passive phase, Pressure-Control Ventilation / ASV order

EXPERIMENTAL

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

Passive phase, ASV / Pressure-Control Ventilation order

EXPERIMENTAL

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

Active phase, Pressure-Support / ASV order

EXPERIMENTAL

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

Active phase, ASV / Pressure-Support order

EXPERIMENTAL

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

Interventions

ASV ventilation PROCEDURE

Ventilation on ASV mode

Active phase, ASV / Pressure-Support order; Active phase, Pressure-Support / ASV order; Passive phase, ASV / Pressure-Control Ventilation order; Passive phase, Pressure-Control Ventilation / ASV order

Eligibility Criteria

• Age: Up to 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lausanne Hospitals: lead

Study Sites (1)

Lausanne University Hospital

Lausanne, 1011, Switzerland

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Ferry, MD

  University of Lausanne Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: April 29, 2019
• Study Start: September 13, 2019
• Primary Completion: December 5, 2023
• Study Completion: December 5, 2023
• Last Updated: December 13, 2023

Record last verified: 2023-12

Locations

CH (1)