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
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Analysis of respiratory tracings will be blinded to the type of respiratory support.|
|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|
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]).
- Asynchrony Index [ Time Frame: 90 minutes ]Difference in Asynchrony index [expressed as percentage] between different modalities of Non-invasive ventilation.
- Ineffective efforts [ Time Frame: 90 minutes ]Difference in ineffective respiratory efforts [number/minute] between different modalities of Non-invasive ventilation.
- Auto-triggering [ Time Frame: 90 minutes ]Difference in auto-triggered respiratory acts [number/minute] between different modalities of Non-invasive ventilation.
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
|Contact: Thomas Langer, MDfirstname.lastname@example.org|
|Contact: Giovanna Chidini, MDemail@example.com|
|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|
|Study Chair:||Edoardo Calderini, MD||Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico|