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
About this trial
This is an interventional other trial for COVID-19
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
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
NCT ID
NCT05358184
First Posted
April 29, 2022
Last Updated
April 30, 2022
Sponsor
University Magna Graecia
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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