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

Guangzhou Institute of Respiratory Disease

Status: Not yet enrolling

Conditions: Non-invasive Ventilation; Healthy Subjects

Treatments: Device: Non-invasive high-frequency oscillatory ventilation; Device: Noninvasive Bilevel Positive Pressure Ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT05448417

GZ-202203

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 25 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age 25-40, males and females;
2. Pulmonary function test found that the subject's lung function was normal;
3. Pulmonary disease not related to the results of the experiment;
4. Willing to participate in the study;
5. Able to provide informed consent.

Exclusion criteria

1. Bronchiectasis; post-tuberculosis sequelae; rib cage deformities; neuromuscular disorders; and bronchial carcinoma.
2. Intolerant with NIV

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

non-invasive high-frequency oscillatory ventilation

Experimental group

Description:

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.

Treatment:

Device: Non-invasive high-frequency oscillatory ventilation

Bilevel positive pressure ventilation

Active Comparator group

Description:

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.

Treatment:

Device: Noninvasive Bilevel Positive Pressure Ventilation