High Frequency Percussive Ventilation in Hypersecretive Tracheostomized Patients

NCT ID: NCT05200507

Last Updated: 2022-01-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2022-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

High Frequency Percussive Ventilation

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Magna Graecia

OTHER

Sponsor Role: lead

Responsible Party

Federico Longhini

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Federico Longhini, MD

Role: PRINCIPAL_INVESTIGATOR

Magna Graecia University

Locations

AOU Mater Domini

Catanzaro, , Italy

Countries

Italy

Central Contacts

Federico Longhini, MD

Role: CONTACT

longhini.federico@gmail.com

+393475395967

Facility Contacts

Federico Longhini, MD

Role: primary

longhini.federico@gmail.com

+3934753959697

References

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.

Reference Type: DERIVED

PMID: 36607533 (View on PubMed)

Other Identifiers

Percussionaire-tracheo

Identifier Type: -

Identifier Source: org_study_id