Pediatric Respiratory Diseases Clinical Trial
— Asyn-VentOfficial 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
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.
Status | Recruiting |
Enrollment | 12 |
Est. completion date | July 15, 2021 |
Est. primary completion date | July 15, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Month to 4 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Milano |
Lead Sponsor | Collaborator |
---|---|
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
Italy,
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Asynchrony Index | Difference in Asynchrony index [expressed as percentage] between different modalities of Non-invasive ventilation. | 90 minutes | |
Secondary | Ineffective efforts | Difference in ineffective respiratory efforts [number/minute] between different modalities of Non-invasive ventilation. | 90 minutes | |
Secondary | Auto-triggering | Difference in auto-triggered respiratory acts [number/minute] between different modalities of Non-invasive ventilation. | 90 minutes |
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