High Frequency Percussive Ventilation in COVID-19 Patients

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05358184
• Other study ID #: Percussionaire COVID
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 15, 2022
• Est. completion date: June 30, 2022

Study information

• Verified date: April 2022
• Source: University Magna Graecia
• Contact: Federico Longhini, MD
• Phone: +393475395967
• Email: longhini.federico[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• COVID-19
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Magna Graecia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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