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

Not Applicable

• Conditions: Non-invasive Ventilation; Healthy Subjects
• Interventions: Device: Non-invasive high-frequency oscillatory ventilation; Device: Noninvasive Bilevel Positive Pressure Ventilation

• Registration Number: NCT05448417
• Lead Sponsor: Guangzhou Institute of Respiratory Disease

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-03
• Study First Submitted QC: 2022-07-03
• Last Update Submitted: 2022-07-03
• Study First Posted: 2022-07-07
• Last Update Posted: 2022-07-07
• Study Start: 2022-07-15
• Primary Completion: 2022-12-30
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
non-invasive high-frequency oscillatory ventilation	Non-invasive high-frequency oscillatory ventilation	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.
Bilevel positive pressure ventilation	Noninvasive Bilevel Positive Pressure Ventilation	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.

Primary Outcome Measures

Name	Time	Method
Asynchrony index	1 hour	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

Trial Locations

Locations (1)

The First Affiliated Hospital of Guangzhou Medical University.; 🇨🇳 Guangdong, China