High Frequency Percussive Ventilation in COVID-19 Patients

High Frequency Percussive Ventilation in COVID-19 Patients Receiving Oxygen Through High-flow Nasal Cannula

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

Study Overview

• Status: Not yet recruiting
• Conditions: COVID-19; Acute Respiratory Failure
• Intervention / Treatment: Device: High frequency Percussive ventilation

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Federico Longhini, MD; Phone Number: +393475395967; Email: longhini.federico@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High frequency percussive ventilation; 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	Device: High frequency Percussive ventilation; High Frequency Percussive Ventilation will be applied for 10 minutes at an oscillation frequency of 10 Hz

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	One hour after the end of HFPV application
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	Three hours after the end of HFPV application
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	5 minutes after the end of HFPV application

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 minutes after the end of HFPV application
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	One hour after the end of HFPV application
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	Three hours after the end of HFPV application

Collaborators and Investigators

• Sponsor: University Magna Graecia

Study record dates

Study Major Dates

• Study Start (Anticipated): May 15, 2022
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: April 29, 2022
• First Submitted That Met QC Criteria: April 30, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Actual): May 3, 2022
• Last Update Submitted That Met QC Criteria: April 30, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Respiratory Insufficiency
• Other Study ID Numbers: Percussionaire COVID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No