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High Frequency Percussive Ventilation in COVID-19 Patients

Primary Purpose

COVID-19, Acute Respiratory Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High frequency Percussive ventilation
Sponsored by
University Magna Graecia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for COVID-19

Eligibility Criteria

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

Inclusion Criteria:

  • acute respiratory failure with a nasal swab positive for SARS-CoV-2
  • need for high-flow oxygen through nasal cannula

Exclusion Criteria:

  • life threatening cardiac arrythmia
  • pneumothorax
  • acute spinal injury
  • chest trauma
  • hemodynamic instability
  • chest or abdominal surgery in the previous 7 days
  • pregnancy
  • enrollment in other study protocols

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    High frequency percussive ventilation

    Arm Description

    High Frequency Percussive Ventilation will be applied for 10 minutes at an oscillation frequency of 10 Hz, superimposed to oxygen therapy at high flow through nasal cannula

    Outcomes

    Primary Outcome Measures

    Lung aeration
    To evaluate if the application of High Frequency Percussive Ventilation (HFPV) will modify the lung aeration (as assessed by the end-expiratory lung impedance through EIT), as compared to baseline before the treatment
    Lung aeration
    To evaluate if the application of High Frequency Percussive Ventilation (HFPV) will modify the lung aeration (as assessed by the end-expiratory lung impedance through EIT), as compared to baseline before the treatment
    Lung aeration
    To evaluate if the application of High Frequency Percussive Ventilation (HFPV) will modify the lung aeration (as assessed by the end-expiratory lung impedance through EIT), as compared to baseline before the treatment

    Secondary Outcome Measures

    Gas exchange
    To evaluate if the application of High Frequency Percussive Ventilation (HFPV) will modify Arterial Blood Gases, as compared to baseline before the treatment
    Gas exchange
    To evaluate if the application of High Frequency Percussive Ventilation (HFPV) will modify Arterial Blood Gases, as compared to baseline before the treatment
    Gas exchange
    To evaluate if the application of High Frequency Percussive Ventilation (HFPV) will modify Arterial Blood Gases, as compared to baseline before the treatment

    Full Information

    First Posted
    April 29, 2022
    Last Updated
    April 30, 2022
    Sponsor
    University Magna Graecia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05358184
    Brief Title
    High Frequency Percussive Ventilation in COVID-19 Patients
    Official Title
    High Frequency Percussive Ventilation in COVID-19 Patients Receiving Oxygen Through High-flow Nasal Cannula
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 15, 2022 (Anticipated)
    Primary Completion Date
    June 30, 2022 (Anticipated)
    Study Completion Date
    June 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Magna Graecia

    4. Oversight

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

    5. Study Description

    Brief Summary
    High frequency percussive ventilation (HFPV) is used in patients with underlying pulmonary atelectasis, excessive airway secretions, and respiratory failure. HFPV is a non-continuous form of high-frequency ventilation delivered by a pneumatic device that provides small bursts of sub-physiological tidal breaths at a frequency of 60-600 cycles/minute superimposed on a patient's breathing cycle. The high-frequency breaths create shear forces causing dislodgement of the airway secretions. Furthermore, the HFPV breath cycle has an asymmetrical flow pattern characterized by larger expiratory flow rates, which may propel the airway secretions towards the central airway. In addition, the applied positive pressure recruits the lung units, resulting in a more homogeneous distribution of ventilation and improved gas exchange. In acute care and critical care settings, HFPV intervention is used in a range of patients, from spontaneously breathing patients to those receiving invasive mechanical ventilation where HFPV breaths can be superimposed on a patient's breathing cycle or superimposed on breaths delivered by a mechanical ventilator. The most common indications for HFPV use are reported as removal of excessive bronchial secretions, improving gas exchange, and recruitment of atelectatic lung segments. This study aims to assess the lung physiological response to HFPV in terms of aeration and ventilation distribution in patients with acute respiratory failure due to SARS-CoV-2 infection and requiring high flow oxygen therapy through nasal cannula

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COVID-19, Acute Respiratory Failure

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    High frequency percussive ventilation
    Arm Type
    Experimental
    Arm Description
    High Frequency Percussive Ventilation will be applied for 10 minutes at an oscillation frequency of 10 Hz, superimposed to oxygen therapy at high flow through nasal cannula
    Intervention Type
    Device
    Intervention Name(s)
    High frequency Percussive ventilation
    Intervention Description
    High Frequency Percussive Ventilation will be applied for 10 minutes at an oscillation frequency of 10 Hz
    Primary Outcome Measure Information:
    Title
    Lung aeration
    Description
    To evaluate if the application of High Frequency Percussive Ventilation (HFPV) will modify the lung aeration (as assessed by the end-expiratory lung impedance through EIT), as compared to baseline before the treatment
    Time Frame
    5 minutes after the end of HFPV application
    Title
    Lung aeration
    Description
    To evaluate if the application of High Frequency Percussive Ventilation (HFPV) will modify the lung aeration (as assessed by the end-expiratory lung impedance through EIT), as compared to baseline before the treatment
    Time Frame
    One hour after the end of HFPV application
    Title
    Lung aeration
    Description
    To evaluate if the application of High Frequency Percussive Ventilation (HFPV) will modify the lung aeration (as assessed by the end-expiratory lung impedance through EIT), as compared to baseline before the treatment
    Time Frame
    Three hours after the end of HFPV application
    Secondary Outcome Measure Information:
    Title
    Gas exchange
    Description
    To evaluate if the application of High Frequency Percussive Ventilation (HFPV) will modify Arterial Blood Gases, as compared to baseline before the treatment
    Time Frame
    5 minutes after the end of HFPV application
    Title
    Gas exchange
    Description
    To evaluate if the application of High Frequency Percussive Ventilation (HFPV) will modify Arterial Blood Gases, as compared to baseline before the treatment
    Time Frame
    One hour after the end of HFPV application
    Title
    Gas exchange
    Description
    To evaluate if the application of High Frequency Percussive Ventilation (HFPV) will modify Arterial Blood Gases, as compared to baseline before the treatment
    Time Frame
    Three hours after the end of HFPV application

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: acute respiratory failure with a nasal swab positive for SARS-CoV-2 need for high-flow oxygen through nasal cannula Exclusion Criteria: life threatening cardiac arrythmia pneumothorax acute spinal injury chest trauma hemodynamic instability chest or abdominal surgery in the previous 7 days pregnancy enrollment in other study protocols
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Federico Longhini, MD
    Phone
    +393475395967
    Email
    longhini.federico@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Federico Longhini, MD
    Organizational Affiliation
    Magna Graecia University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Anonymous data will be shared after study publication on a peer-reviewed journal in english language, on a reasonable request to the principal investigator
    IPD Sharing Time Frame
    After study publication on a peer-reviewed journal in english language
    IPD Sharing Access Criteria
    On reasonable request to the Principal Investigator

    Learn more about this trial

    High Frequency Percussive Ventilation in COVID-19 Patients

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