High Frequency Percussive Ventilation in Hypersecretive Tracheostomized Patients

Physiological Effects on Lung Aeration of High Frequency Percussive Ventilation in Hypersecretive Tracheostomized Patients: a Physiological Observational Study

The incidence of pulmonary complications such as pulmonary atelectasis, pneumonia (including ventilator-associated pneumonia), and acute respiratory failure is high in critical care patients. The incidence of ventilator-associated pneumonia can be as high as 27% amongst mechanically ventilated patients. Studies have shown that 16% of critically ill patients have been reported to develop acute respiratory failure, which is associated with prolonged intensive care unit stay, resulting in significantly higher mortality than non-respiratory failure patients. Increased morbidity and mortality contribute to the burden on the health care system and lead to poor health-related outcomes. Multimodal physiotherapy plays a role in the management of these critically ill patients. 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pneumonia; Acute Respiratory Failure
• Intervention / Treatment: Device: High Frequency Percussive Ventilation

• Study Type: Observational
• Enrollment (Anticipated): 15

Contacts and Locations

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

Study Locations

• Italy
  • Catanzaro, Italy
    • AOU Mater Domini
    • Contact: Federico Longhini, MD; Phone Number: +3934753959697; 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

• Sampling Method: Probability Sample

Study Population

All tracheostomized patients requiring invasive mechanical ventilation for more than 48 hours and with an hypersecretive condition (as defined by need for two or more broncoaspirations per hour in the previous 8 hours) will be considered eligible. Patients will be excluded if contro-indications to High Frequency Percussive Ventilation and/or Electrical Impedance Tomography exist.

Description

Inclusion Criteria:

• more than 48 hours of invasive mechanical ventilation
• presence of tracheostomy
• need for two or more broncoaspirations per hour in the previous 8 hours

Exclusion Criteria:

• life threatening cardiac arrythmia
• pneumothorax
• acute spinal injury
• chest trauma
• brain injury in the previous 15 days
• hemodynamic instability
• chest or abdominal surgery in the previous 7 days
• pregnancy
• enrollment in other study protocols

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
High frequency precussive ventilation; After positioning a silicon belt for Electrical Impedance Tomography (EIT) and a baseline record, patients will receive the treatment of High Frequency Percussive Ventilation. Further recordings will be acquired soon after the end of the treatment, 1 and 3 hours later.	Device: High Frequency Percussive Ventilation; High Frequency Percussive Ventilation will be applied for 10 minutes at an oscillation frequency of 10 Hz, superimposed to the ventilatory assistance

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	Soon 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial Blood Gases	To evaluate if the application of High Frequency Percussive Ventilation (HFPV) will modify Arterial Blood Gases, as compared to baseline before the treatment	Soon after the end of HFPV application
Arterial Blood Gases	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
Arterial Blood Gases	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): February 1, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: January 6, 2022
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): January 20, 2022
• Last Update Submitted That Met QC Criteria: January 6, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Secretions; tracheostomized critically ill patients
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: Percussionaire-tracheo

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