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

NCT05435183 | Unknown

• 1 other identifier: GIRH-202203
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD; Non-invasive Ventilation

Keywords

Noninvasive high frequency oscillatory ventilation

Outcome Measures

Primary Outcomes (1)

• Transcutaneous partial pressure of CO2

  Monitor arterial blood carbon dioxide changes during patient intervention by professional transcutaneous carbon dioxide monitoring equipment

  1 hour

Secondary Outcomes (1)

• Asynchrony index

  1 hour

Study Arms (2)

non-invasive high-frequency oscillatory ventilation

EXPERIMENTAL

Patients were titrated for relevant parameters of non-invasive ventilation the day before the trial. In the non-invasive high-frequency oscillation ventilation mode, the support pressure is consistent with the non-invasive bi-level positive pressure mode, and the high-frequency 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

Bilevel positive pressure ventilation

ACTIVE COMPARATOR

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

Interventions

Non-invasive high-frequency oscillatory ventilation DEVICE

Non-invasive high-frequency oscillatory ventilation generates high-frequency pressure fluctuations in the airway caused by the opening and closing of a solenoid valve.

non-invasive high-frequency oscillatory ventilation

Noninvasive Bilevel Positive Pressure Ventilation DEVICE

Noninvasive Bilevel Positive Pressure Ventilation

Bilevel positive pressure ventilation

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40-80, males and females;
• Stage III and IV COPD and PaCO2≥50mmHg;
• Similar with non-invasive ventilation;
• Willing to participate in the study;
• Able to provide informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University.

Guangdong, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jianyi Niu, MD

CONTACT

17825846046; niujianyi001@163.com

Rongchang Chen, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: June 28, 2022
• Study Start: June 30, 2022
• Primary Completion: December 30, 2022
• Study Completion: June 30, 2023
• Last Updated: June 28, 2022

Record last verified: 2022-06

Locations

CN (1)