High Frequency Percussive Ventilation in COVID-19 Patients

NCT05358184 | Unknown

• 1 other identifier: Percussionaire COVID
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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

Conditions

COVID-19; Acute Respiratory Failure

Outcome Measures

Primary Outcomes (3)

• 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

• 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

Secondary Outcomes (3)

• Gas exchange

  5 minutes after the end of HFPV application

• Gas exchange

  One hour after the end of HFPV application

• Gas exchange

  Three hours after the end of HFPV application

Study Arms (1)

High frequency percussive ventilation

EXPERIMENTAL

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

Interventions

High frequency Percussive ventilation DEVICE

High Frequency Percussive Ventilation will be applied for 10 minutes at an oscillation frequency of 10 Hz

High frequency percussive ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Magna Graecia: lead

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Federico Longhini, MD

  Magna Graecia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Federico Longhini, MD

CONTACT

+393475395967; longhini.federico@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Intensive Care and Anesthesia Department

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 3, 2022
• Study Start: May 15, 2022
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: May 3, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE
• Time Frame: After study publication on a peer-reviewed journal in english language
• Access Criteria: On reasonable request to the Principal Investigator