Effect of Noninvasive High Frequency Oscillatory Ventilation on Improving CO2 Clearance in COPD Patients

NCT05721833 | Unknown

• 1 other identifier: GIRH-202203-1
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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 Exacerbation; Non-invasive Ventilation

Keywords

Noninvasive ventilation; High frequency oscillatory ventilation; COPD

Outcome Measures

Primary Outcomes (1)

• Partial pressure of carbon dioxide in peripheral blood

  After the peripheral blood was arterialized for 10 minutes, 100 ul of the patient's finger peripheral blood was taken to measure the partial pressure of carbon dioxide in the peripheral blood.

  within 50 minutes after intervention

Secondary Outcomes (1)

• Asynchrony index

  within 50 minutes after intervention

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

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 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

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

+8617825846046; niujianyi001@163.com

Rongchang Chen, PhD

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: November 14, 2022
• First Posted: February 10, 2023
• Study Start: February 10, 2023
• Primary Completion: May 30, 2023
• Study Completion: June 30, 2023
• Last Updated: February 10, 2023

Record last verified: 2023-02