Asynchronies in Pediatric Noninvasive Ventilation

NCT04017780 | Unknown

• 1 other identifier: ASYN-VENT
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Respiratory Diseases

Keywords

Noninvasive Ventilation; Acute Respiratory Failure; Pediatrics

Outcome Measures

Primary Outcomes (1)

• Asynchrony Index

  Difference in Asynchrony index \[expressed as percentage\] between different modalities of Non-invasive ventilation.

  90 minutes

Secondary Outcomes (2)

• Ineffective efforts

  90 minutes

• Auto-triggering

  90 minutes

Study Arms (3)

Single-limb circuit with turbine-driven ventilator

EXPERIMENTAL

Non invasive ventilation delivered with a turbine-driven ventilator, single limb with intentional leaks.

Device: Single-Limb Turbine-Driven Ventilator

Double-limb circuit with Intensive Care Unit ventilator

EXPERIMENTAL

Non invasive ventilation delivered with an intensive care unit ventilator with a double limb circuit.

Device: Double-Limb Intensive Care Unit ventilator

Double-limb circuit with turbine-driven ventilator

EXPERIMENTAL

Non invasive ventilation delivered with a turbine-driven ventilator with a double limb circuit.

Device: Double-Limb Turbine-Driven Ventilator

Interventions

Single-Limb Turbine-Driven Ventilator DEVICE

Non invasive ventilation performed with a single limb circuit and intentional leak (vented mask) delivered with a turbine-driven ventilator (Astral 150 \[ResMed\]).

Single-limb circuit with turbine-driven ventilator

Double-Limb Intensive Care Unit ventilator DEVICE

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).

Double-limb circuit with Intensive Care Unit ventilator

Double-Limb Turbine-Driven Ventilator DEVICE

Non invasive ventilation performed with a double limb circuit and expiratory valve incorporated in the ventilator, delivered with a turbine-driven ventilator (Astral 150 \[ResMed\]).

Double-limb circuit with turbine-driven ventilator

Eligibility Criteria

• Age: 1 Month - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Milan, 20122, Italy

RECRUITING

Related Publications (19)

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  PMID: 11316635 BACKGROUND

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  PMID: 12185424 BACKGROUND

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  PMID: 19352622 BACKGROUND

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  PMID: 16896854 BACKGROUND

Study Officials

• Edoardo Calderini, MD

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  STUDY CHAIR

Central Study Contacts

Thomas Langer, MD

CONTACT

+39-2-55032242; thomas.langer@unimi.it

Giovanna Chidini, MD

CONTACT

+39-2-55032242; giovanna.chidini@policlinico.mi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Analysis of respiratory tracings will be blinded to the type of respiratory support.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 12, 2019
• Study Start: September 15, 2019
• Primary Completion: July 15, 2021
• Study Completion: July 15, 2021
• Last Updated: November 27, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)