High Frequency Percussive Ventilation in Hypersecretive Tracheostomized Patients

NCT05200507 | Unknown

• 1 other identifier: Percussionaire-tracheo
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Respiratory Failure; Pneumonia

Keywords

Secretions; tracheostomized critically ill patients

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

  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 Outcomes (3)

• Arterial Blood Gases

  Soon after the end of HFPV application

• Arterial Blood Gases

  One hour after the end of HFPV application

• Arterial Blood Gases

  Three hours after the end of HFPV application

Study Arms (1)

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

Interventions

High Frequency Percussive Ventilation DEVICE

High Frequency Percussive Ventilation will be applied for 10 minutes at an oscillation frequency of 10 Hz, superimposed to the ventilatory assistance

High frequency precussive ventilation

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Magna Graecia: lead

Study Sites (1)

AOU Mater Domini

Catanzaro, Italy

Location

Related Publications (1)

• Garofalo E, Rovida S, Cammarota G, Biamonte E, Troisi L, Cosenza L, Pelaia C, Navalesi P, Longhini F, Bruni A. Benefits of secretion clearance with high frequency percussive ventilation in tracheostomized critically ill patients: a pilot study. J Clin Monit Comput. 2023 Jun;37(3):911-918. doi: 10.1007/s10877-022-00970-7. Epub 2023 Jan 6.

  PMID: 36607533 DERIVED

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; 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: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: January 20, 2022
• Study Start: February 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 20, 2022

Record last verified: 2022-01

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

Locations

IT (1)