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

NCT ID: NCT05435183

Last Updated: 2022-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-30

Study Completion Date

2023-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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COPD Non-invasive Ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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non-invasive high-frequency oscillatory ventilation

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.

Group Type EXPERIMENTAL

Non-invasive high-frequency oscillatory ventilation

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Noninvasive Bilevel Positive Pressure Ventilation

Intervention Type DEVICE

Noninvasive Bilevel Positive Pressure Ventilation

Interventions

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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.

Intervention Type DEVICE

Noninvasive Bilevel Positive Pressure Ventilation

Noninvasive Bilevel Positive Pressure Ventilation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou Institute of Respiratory Disease

OTHER

Sponsor Role lead

Responsible Party

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Jianyi Niu

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The First Affiliated Hospital of Guangzhou Medical University.

Guangdong, , China

Site Status

Countries

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China

Central Contacts

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Jianyi Niu, MD

Role: CONTACT

17825846046

Rongchang Chen, MD

Role: CONTACT

Facility Contacts

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Jianyi Niu

Role: primary

17825846046

Other Identifiers

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GIRH-202203

Identifier Type: -

Identifier Source: org_study_id

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