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

• Sponsor: Guangzhou Institute of Respiratory Disease (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05448417
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 11.5
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-invasive Ventilation; Healthy Subjects	Device: Non-invasive high-frequency oscillatory ventilation; Device: Noninvasive Bilevel Positive Pressure Ventilation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention 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.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)
• Primary Purpose: Treatment
• Official Title: Exploration of Non-invasive High-frequency Oscillations in Human-machine Asynchrony in Healthy Subjects : a Clinical Crossover Trial
• Anticipated Study Start Date: Jul 15, 2022
• Anticipated Primary Completion Date: Dec 30, 2022
• Anticipated Study Completion Date: Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: Non-invasive high-frequency oscillatory ventilation; Non-invasive high-frequency oscillatory ventilation generates high-frequency pressure fluctuations in the airway caused by the opening and closing of a solenoid valve.
Active Comparator: 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.	Device: Noninvasive Bilevel Positive Pressure Ventilation; Noninvasive Bilevel Positive Pressure Ventilation

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Guangzhou Medical University.	Guangdong		China

Sponsors and Collaborators

• Guangzhou Institute of Respiratory Disease

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jianyi Niu, Principle investigator, Guangzhou Institute of Respiratory Disease
• ClinicalTrials.gov Identifier: NCT05448417
• Other Study ID Numbers: GZ-202203
• First Posted: Jul 7, 2022
• Last Update Posted: Jul 7, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jianyi Niu, Principle investigator, Guangzhou Institute of Respiratory Disease: Noninvasive high frequency oscillatory ventilation

Study Results

No Results Posted as of Jul 7, 2022