Exploration of Non-invasive High-frequency Oscillations in Human-machine Asynchrony in Healthy Subjects

Study Overview
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Brief Summary
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High-frequency oscillatory ventilation (HFOV), as an ideal lung-protecting ventilation method, has been gradually applied to neonatal intensive care treatment, and is currently recommended as a rescue method for neonatal acute respiratory distress syndrome (ARDS) after conventional mechanical treatment fails. ventilation. Non-invasive high-frequency oscillatory ventilation (nHFOV) combines the advantages of HFOV and non-invasive ventilation methods, and has become a research hotspot in this field. Recommended to avoid intubation after failure of conventional non-invasive ventilation therapy. There is a lack of large-scale clinical trials systematically exploring its efficacy for intubation therapy. The increasing clinical application of nHFOV has also enriched its application in the treatment of other diseases. Human-machine asynchrony during non-invasive ventilation will seriously affect its efficacy, but no one has reported on the research related to nHFOV human-machine asynchrony.

Official Title
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Exploration of Non-invasive High-frequency Oscillations in Human-machine Asynchrony in Healthy Subjects : a Clinical Crossover Trial

Conditions
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Non-invasive Ventilation, Healthy Subjects

Intervention / Treatment
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* Device: Non-invasive high-frequency oscillatory ventilation
* Device: Noninvasive Bilevel Positive Pressure Ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 25-40, males and females; Pulmonary function test found that the subject's lung function was normal; Pulmonary disease not related to the results of the experiment; Willing to participate in the study; Able to provide informed consent. Exclusion Criteria: Bronchiectasis; post-tuberculosis sequelae; rib cage deformities; neuromuscular disorders; and bronchial carcinoma. Intolerant with NIV

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Patients were randomized to receive one hour each of the two non-invasive ventilation modes before and after, and one hour of washout after receiving the first mode of ventilation before receiving the second intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: non-invasive high-frequency oscillatory ventilation<br>Patients were titrated for relevant parameters of noninvasive ventilation the day before the trial. In the non-invasive high-frequency oscillation ventilation mode, the support pressure is consistent with the noninvasive bi-level positive pressure mode, and the highfrequency airway pressure oscillation driven by the solenoid valve is added during the expiratory phase. The amplitude is about 4cmH2O, and the oscillation frequency is about 8HZ. | Device: Non-invasive high-frequency oscillatory ventilation<br>* Non-invasive high-frequency oscillatory ventilation generates high-frequency pressure fluctuations in the airway caused by the opening and closing of a solenoid valve.<br>|
| Active Comparator: Bilevel positive pressure ventilation<br>Bilevel positive pressure ventilation Patients were titrated for relevant parameters of non-invasive ventilation the day before the trial. Noninvasive bilevel positive pressure ventilation mode pressure titration follows previous studies. | Device: Noninvasive Bilevel Positive Pressure Ventilation<br>* Noninvasive Bilevel Positive Pressure Ventilation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asynchrony index | Asynchrony index is defined as the number of asynchrony events divided by the total espiratory rate computed as the sum of the number of ventilator cycles (triggered or not) and of wasted efforts: asynchrony Index (expressed in percentage) = number of asynchrony events/total respiratory rate (ventilator cycles +wasted efforts) × 100 | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Noninvasive high frequency oscillatory ventilation