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Asynchronies in Pediatric Noninvasive Ventilation (Asyn-Vent)

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ClinicalTrials.gov Identifier: NCT04017780
Recruitment Status : Not yet recruiting
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Brief Summary:

The term ''Non-invasive ventilation'' (NIV) refers to various methods of respiratory assistance, in the absence of an indwelling endotracheal tube. In recent years, the use of NIV has increased for the treatment of both acute and chronic pediatric respiratory failure. Patient tolerance to the technique is a critical factor determining its success in avoiding endotracheal intubation. One of the key factors determining tolerance to NIV is optimal synchrony between the patient's spontaneous breathing activity and the ventilator's set parameters, known as ''patient-ventilator interaction''.

Indeed, synchronization of the ventilator breath with the patient's inspiratory effort, optimizes comfort, minimizes work of breathing and reduces the need for sedation. During NIV, several factors can significantly interfere with the function of the ventilator, leading to an increased risk of asynchrony. Indeed, the presence of unintentional leaks at the patient-mask interface, the sensitivity of inspiratory and expiratory triggers, the ability to compensate for intentional and unintentional leaks and the presence/absence of expiratory valves are all factors that likely play a role in determining patient-ventilator synchronization.

The investigators therefore designed the present crossover trial in order to compare the degree of respiratory asynchronies during NIV using different ventilators (Turbine-driven ventilator vs. compressed air-driven ICU ventilators) and different setups (single circuit vs. double circuit) in children with acute respiratory failure.


Condition or disease Intervention/treatment Phase
Pediatric Respiratory Diseases Device: Single-Limb Turbine-Driven Ventilator Device: Double-Limb Intensive Care Unit ventilator Device: Double-Limb Turbine-Driven Ventilator Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Analysis of respiratory tracings will be blinded to the type of respiratory support.
Primary Purpose: Treatment
Official Title: Role of Type of Respiratory Circuit and Type of Ventilator on Asynchronies During Non-invasive Ventilation (NIV) in Children With Acute Respiratory Failure: an Interventional, Nonpharmacological Crossover Study
Estimated Study Start Date : July 15, 2019
Estimated Primary Completion Date : July 15, 2021
Estimated Study Completion Date : July 15, 2021

Arm Intervention/treatment
Experimental: Single-limb circuit with turbine-driven ventilator
Non invasive ventilation delivered with a turbine-driven ventilator, single limb with intentional leaks.
Device: Single-Limb Turbine-Driven Ventilator
Non invasive ventilation performed with a single limb circuit and intentional leak (vented mask) delivered with a turbine-driven ventilator (Astral 150 [ResMed]).

Experimental: Double-limb circuit with Intensive Care Unit ventilator
Non invasive ventilation delivered with an intensive care unit ventilator with a double limb circuit.
Device: Double-Limb Intensive Care Unit ventilator
Non invasive ventilation performed with a double limb circuit and expiratory valve incorporated in the ventilator, delivered with a pediatric/neonatal intensive care unit ventilator (Babylog VN500, Draeger).

Experimental: Double-limb circuit with turbine-driven ventilator
Non invasive ventilation delivered with a turbine-driven ventilator with a double limb circuit.
Device: Double-Limb Turbine-Driven Ventilator
Non invasive ventilation performed with a double limb circuit and expiratory valve incorporated in the ventilator, delivered with a turbine-driven ventilator (Astral 150 [ResMed]).




Primary Outcome Measures :
  1. Asynchrony Index [ Time Frame: 90 minutes ]
    Difference in Asynchrony index [expressed as percentage] between different modalities of Non-invasive ventilation.


Secondary Outcome Measures :
  1. Ineffective efforts [ Time Frame: 90 minutes ]
    Difference in ineffective respiratory efforts [number/minute] between different modalities of Non-invasive ventilation.

  2. Auto-triggering [ Time Frame: 90 minutes ]
    Difference in auto-triggered respiratory acts [number/minute] between different modalities of Non-invasive ventilation.



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Ages Eligible for Study:   1 Month to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with acute hypoxic (SpO2/FIO2 ratio < 315) or hypercapnic (PvCO2 > 52 mmHg and venous pH <7.28) respiratory failure in which non-invasive respiratory support is clinically indicated
  • Age: > 28 days and < 4 years
  • Patients whose parents provided signed informed consent

Exclusion Criteria:

  • Age > 4 years or < 28 days
  • Patients whose parents did not provide signed informed consent
  • Clinical contraindications to non-invasive ventilation
  • Clinical contraindication to the placement of an esophageal balloon

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04017780


Contacts
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Contact: Thomas Langer, MD +39-2-55032242 thomas.langer@unimi.it
Contact: Giovanna Chidini, MD +39-2-55032242 giovanna.chidini@policlinico.mi.it

Locations
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Italy
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Not yet recruiting
Milano, Italy, 20122
Contact: Thomas Langer    0255033232      
Contact: Giovanna Chidini         
Sub-Investigator: Cristina Villa, MD         
Sub-Investigator: Giulia Spolidoro, MD         
Sub-Investigator: Veronica Doria, MD         
Sub-Investigator: Edi Prandi, MD         
Sponsors and Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Investigators
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Study Chair: Edoardo Calderini, MD Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Publications:

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Responsible Party: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier: NCT04017780     History of Changes
Other Study ID Numbers: ASYN-VENT
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:
Noninvasive Ventilation
Acute Respiratory Failure
Pediatrics
Additional relevant MeSH terms:
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Respiration Disorders
Respiratory Tract Diseases