Clinical trial NCT05200507: High Frequency Percussive Ventilation in Hypersecretive Tracheostomized Patients
Official title: Physiological Effects on Lung Aeration of High Frequency Percussive Ventilation in Hypersecretive Tracheostomized Patients: a Physiological Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Respiratory Failure
Pneumonia
Keywords: Secretions
tracheostomized critically ill patients
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Lung aeration
timeFrame: Soon after the end of HFPV application
measure: Lung aeration
timeFrame: One hour after the end of HFPV application
measure: Lung aeration
timeFrame: Three hours after the end of HFPV application
Secondary outcomes:
measure: Arterial Blood Gases
timeFrame: Soon after the end of HFPV application
measure: Arterial Blood Gases
timeFrame: One hour after the end of HFPV application
measure: Arterial Blood Gases
timeFrame: Three hours after the end of HFPV application
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: AOU Mater Domini
Study officials:
affiliation: Magna Graecia University
name: Federico Longhini, MD
role: PRINCIPAL_INVESTIGATOR
References: