Effect of Noninvasive High Frequency Oscillatory Ventilation on Improving Carbon Dioxide Clearance in AECOPD Patients

COPD Clinical Trial

Official title:

Effect of Noninvasive High Frequency Oscillatory Ventilation on Improving Carbon Dioxide Clearance in AECOPD Patients : a Clinical Crossover Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05435183
• Other study ID #: GIRH-202203
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 30, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: June 2022
• Source: Guangzhou Institute of Respiratory Disease
• Contact: Jianyi Niu, MD
• Phone: 17825846046
• Email: niujianyi001[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

High-frequency oscillatory ventilation (HFOV), as an ideal lung-protecting ventilation method, has been gradually used in neonatal critical care treatment, and is currently recommended as a rescue method for neonatal acute respiratory distress syndrome (ARDS) after failure of conventional mechanical ventilation. . Although its ability to improve oxygenation and enhance carbon dioxide (CO2) scavenging has been repeatedly demonstrated in laboratory studies, its impact on clinical outcomes in these patients remains uncertain. Non-invasive high-frequency oscillatory ventilation (nHFOV) combines the advantages of HFOV and non-invasive ventilation methods, and has become a current research hotspot in this field. It is recommended to be used to avoid intubation after conventional non-invasive ventilation therapy fails. For the treatment of intubation, there is still a lack of large-scale clinical trials to systematically explore its efficacy. The gradual increase in the clinical application of nHFOV has also enriched its use in the treatment of other diseases.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: June 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age 40-80, males and females;

2. Stage III and IV COPD and PaCO2=50mmHg;

3. Similar with non-invasive ventilation;

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

Related Conditions & MeSH terms

• COPD
• Non-invasive Ventilation

Intervention

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.
• Noninvasive Bilevel Positive Pressure Ventilation
Noninvasive Bilevel Positive Pressure Ventilation

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Guangzhou Medical University.	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Institute of Respiratory Disease

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transcutaneous partial pressure of CO2	Monitor arterial blood carbon dioxide changes during patient intervention by professional transcutaneous carbon dioxide monitoring equipment	1 hour
Secondary	Asynchrony index	Asynchrony index is defined as the number of asynchrony events divided by the total respiratory 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