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The Difference Between Non-invasive High-frequency Oscillatory Ventilation and Non-invasive Continuous Airway Pressure Ventilation in COVID-19 With Acute Hypoxemia

Primary Purpose

COVID-19 Pneumonia, Non-invasive Ventilation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Non-invasive high-frequency oscillatory ventilation
Non-invasive continuous positive airway pressure ventilation
Sponsored by
Guangzhou Institute of Respiratory Disease
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 Pneumonia focused on measuring Noninvasive high frequency oscillatory ventilation, COVID-19 Pneumonia, acute hypoxic respiratory failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: After COVID-19 nucleic acid detection, imaging confirmed COVID-19; Age ≥ 18 years old; At the time of admission, the blood gas was acute hypoxic respiratory failure, the fraction of inhaled oxygen concentration (Fio2) was at least 0.40, but the blood oxygen saturation (Spo2) was 94% or lower; Be able to follow the instructions of the researcher. Exclusion Criteria: Critically ill patients: cardiac and respiratory arrest, requiring tracheal intubation; Multiple organ failure (>2 organs); Hemodynamic instability; After extubation of invasive mechanical ventilation; Patients who cannot wear a mask, such as maxillofacial or upper airway surgery; Patients who may affect the treatment effect of NPPV, such as nasal obstruction or upper respiratory tract obstruction; Obvious bullae, pneumothorax and pleural effusion; It is accompanied by obvious other respiratory diseases, such as bronchiectasis and lung cancer; Those who refuse to participate in this test.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    non-invasive high-frequency oscillatory ventilation

    continuous positive airway pressure ventilation

    Arm Description

    The day before the test, the patient was titrated with the oxygen concentration under non-invasive ventilation. The non-invasive continuous positive airway pressure ventilation was used, the pressure was set at 8cmH2O, and the oxygen concentration was titrated when the blood oxygen saturation was greater than 92% during non-invasive ventilation, and the oxygen concentration in the respiratory tube was constant after the test. In non-invasive high-frequency oscillatory ventilation mode, maintain the same positive airway pressure setting, and superimpose high-frequency oscillatory airflow with amplitude of 6cmH2O and oscillatory frequency of 10HZ.

    The patient was titrated with non-invasive ventilator-related parameters and oxygen uptake concentration the day before the test, and the parameter setting was maintained in the formal experiment.

    Outcomes

    Primary Outcome Measures

    ROX index
    (SpO2/FiO2)/RR

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    January 28, 2023
    Last Updated
    January 28, 2023
    Sponsor
    Guangzhou Institute of Respiratory Disease
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05706467
    Brief Title
    The Difference Between Non-invasive High-frequency Oscillatory Ventilation and Non-invasive Continuous Airway Pressure Ventilation in COVID-19 With Acute Hypoxemia
    Official Title
    The Difference Between Non-invasive High-frequency Oscillatory Ventilation and Non-invasive Continuous Airway Pressure Ventilation in COVID-19 With Acute Hypoxemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 10, 2023 (Anticipated)
    Primary Completion Date
    April 30, 2023 (Anticipated)
    Study Completion Date
    May 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Guangzhou Institute of Respiratory Disease

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    High frequency oscillatory ventilation (HFOV), as an ideal lung protection 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 failure of conventional mechanical ventilation. Although its ability to improve oxygenation and enhance carbon dioxide (CO2) clearance has been repeatedly demonstrated in laboratory studies, its impact on the clinical results of these patients is still uncertain. Noninvasive high-frequency oscillatory ventilation (nHFOV) combines the advantages of HFOV and non-invasive ventilation, and has become the current research focus in this field. It is recommended to use it after the failure of routine non-invasive ventilation treatment to avoid intubation. For the treatment of intubation, there is still a lack of large-scale clinical trials to systematically explore its efficacy. The gradual increase of clinical application of nHFOV has also enriched its application in the treatment of other diseases. At present, non-invasive high-frequency oscillatory ventilation has not been applied to the study of adult COVID-19 with acute hypoxemia, which will be the first study in this field.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COVID-19 Pneumonia, Non-invasive Ventilation
    Keywords
    Noninvasive high frequency oscillatory ventilation, COVID-19 Pneumonia, acute hypoxic respiratory failure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Subjects who met the inclusion criteria received two kinds of non-invasive positive pressure ventilation treatment, namely, non-invasive continuous positive pressure ventilation and non-invasive high-frequency oscillatory ventilation.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    non-invasive high-frequency oscillatory ventilation
    Arm Type
    Experimental
    Arm Description
    The day before the test, the patient was titrated with the oxygen concentration under non-invasive ventilation. The non-invasive continuous positive airway pressure ventilation was used, the pressure was set at 8cmH2O, and the oxygen concentration was titrated when the blood oxygen saturation was greater than 92% during non-invasive ventilation, and the oxygen concentration in the respiratory tube was constant after the test. In non-invasive high-frequency oscillatory ventilation mode, maintain the same positive airway pressure setting, and superimpose high-frequency oscillatory airflow with amplitude of 6cmH2O and oscillatory frequency of 10HZ.
    Arm Title
    continuous positive airway pressure ventilation
    Arm Type
    Active Comparator
    Arm Description
    The patient was titrated with non-invasive ventilator-related parameters and oxygen uptake concentration the day before the test, and the parameter setting was maintained in the formal experiment.
    Intervention Type
    Device
    Intervention Name(s)
    Non-invasive high-frequency oscillatory ventilation
    Intervention Description
    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
    Intervention Name(s)
    Non-invasive continuous positive airway pressure ventilation
    Intervention Description
    Non-invasive positive airway pressure ventilation is carried out through non-invasive ventilator.
    Primary Outcome Measure Information:
    Title
    ROX index
    Description
    (SpO2/FiO2)/RR
    Time Frame
    30 minutes
    Secondary Outcome Measure Information:
    Title
    Asynchrony index
    Description
    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
    Time Frame
    30 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: After COVID-19 nucleic acid detection, imaging confirmed COVID-19; Age ≥ 18 years old; At the time of admission, the blood gas was acute hypoxic respiratory failure, the fraction of inhaled oxygen concentration (Fio2) was at least 0.40, but the blood oxygen saturation (Spo2) was 94% or lower; Be able to follow the instructions of the researcher. Exclusion Criteria: Critically ill patients: cardiac and respiratory arrest, requiring tracheal intubation; Multiple organ failure (>2 organs); Hemodynamic instability; After extubation of invasive mechanical ventilation; Patients who cannot wear a mask, such as maxillofacial or upper airway surgery; Patients who may affect the treatment effect of NPPV, such as nasal obstruction or upper respiratory tract obstruction; Obvious bullae, pneumothorax and pleural effusion; It is accompanied by obvious other respiratory diseases, such as bronchiectasis and lung cancer; Those who refuse to participate in this test.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jianyi Niu, M.D.
    Phone
    +8617825846046
    Email
    2020218509@stu.gzhmu.edu.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rongchang Chen, M.D.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jianyi Niu, M.D.
    Organizational Affiliation
    The First Affiliated Hospital of Guangzhou Medical University. Guangdong, China
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Difference Between Non-invasive High-frequency Oscillatory Ventilation and Non-invasive Continuous Airway Pressure Ventilation in COVID-19 With Acute Hypoxemia

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