Acute Respiratory FailureNCT05200507
High Frequency Percussive Ventilation in Hypersecretive Tracheostomized Patients
An observational study of Acute Respiratory Failure and Pneumonia, run by University Magna Graecia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure, Pneumonia
- What is being tested?
- High Frequency Percussive Ventilation
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2022to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- more than 48 hours of invasive mechanical ventilation
- presence of tracheostomy
- need for two or more broncoaspirations per hour in the previous 8 hours
Who cannot join
- life threatening cardiac arrythmia
- pneumothorax
- acute spinal injury
- chest trauma
- brain injury in the previous 15 days
- hemodynamic instability
Show all 9Show fewer
- chest or abdominal surgery in the previous 7 days
- pregnancy
- enrollment in other study protocols
Trial locations and contacts
1 site in 1 country.
Italy1 site
AOU Mater Domini
Catanzaro
Federico Longhini, MD, +3934753959697, longhini.federico@gmail.com
About this study
Official title: 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.
- Conditions
- Acute Respiratory Failure, Pneumonia
- Being tested
- High Frequency Percussive Ventilation
- Keywords
- Secretions, tracheostomized critically ill patients
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Frequency Percussive VentilationDevice
High Frequency Percussive Ventilation will be applied for 10 minutes at an oscillation frequency of 10 Hz, superimposed to the ventilatory assistance
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: High Frequency Percussive Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Three hours after the end of HFPV application
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: Three hours after the end of HFPV application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start1 Feb 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Magna Graecia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federico Longhini, University Magna Graecia
- Investigators
- Federico Longhini, MD, Principal investigator, Magna Graecia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200507
- Sponsor's protocol ID
- Percussionaire-tracheo
- Status last verified
- Jan 2022
- First submitted
- 6 Jan 2022
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymous data will be shared after study publication on a peer-reviewed journal in english language, on a reasonable request to the principal investigator
Publications
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.
PubMed 36607533
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Effects on Lung Aeration of High Frequency Percussive Ventilation in Hypersecretive Tracheostomized Patients: a Physiological Observational Study
- ClinicalTrials.gov ID
- NCT05200507
- Acronym / sponsor ID
- Percussionaire-tracheo
- Conditions
- Acute Respiratory Failure, Pneumonia
- Keywords
- Secretions, tracheostomized critically ill patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Magna GraeciaUniversity, hospital or other
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High frequency precussive ventilation | – | Device: High Frequency Percussive VentilationAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- more than 48 hours of invasive mechanical ventilation
- presence of tracheostomy
- need for two or more broncoaspirations per hour in the previous 8 hours
Key exclusion criteria (9 listed)
- life threatening cardiac arrythmia
- pneumothorax
- acute spinal injury
- chest trauma
- brain injury in the previous 15 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Frequency Percussive VentilationHigh Frequency Percussive Ventilation will be applied for 10 minutes at an oscillation frequency of 10 Hz, superimposed to the ventilatory assistance | Device | High frequency precussive ventilation |
Primary outcome
Lung aeration
Time frame: Soon after the end of HFPV application
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
Lung aeration
Time frame: One hour after the end of HFPV application
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
Lung aeration
Time frame: Three hours after the end of HFPV application
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
3 secondary outcomes
Arterial Blood Gases
Time frame: Soon after the end of HFPV application
Arterial Blood Gases
Time frame: One hour after the end of HFPV application
Arterial Blood Gases
Time frame: Three hours after the end of HFPV application
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
- Derived from this study: PubMed 36607533Garofalo 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.
- Individual participant dataSharing planned: Yes. Anonymous data will be shared after study publication on a peer-reviewed journal in english language, on a reasonable request to the principal investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Federico Longhini, MD principal investigator
Magna Graecia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure and Pneumonia, run by University Magna Graecia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Federico Longhini, MD (+393475395967, longhini.federico@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung aeration (time frame: Soon after the end of HFPV application). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05200507, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2022.