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Acute Respiratory FailureVICOR2NCT05751707

VICOR Study-High Frequency Chest Wall Oscillations (HFCWO) in Patients With Acute Respiratory Failure and Hypersecretion

A study testing High Frequency Chest Wall Oscillations via The Vest® Airway Clearance System in people with Acute Respiratory Failure and Acute-on-chronic Respiratory Failure, run by Raffaele Scala at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The study aims to evaluates if the treatment with HFCWO Via The Vest® Airway Clearance System, in addition to standard care in critically ill patients admitted in the Respiratory Intensive Care Unit for acute respiratory failure or acute on chronic respiratory failure and unable to manage secretions, could primarily… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
High Frequency Chest Wall Oscillations via The Vest® Airway Clearance System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteItaly
Study dates
24 Dec 2022to 24 Dec 2024
Phase
Interventional
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

Who may be able to join

  • Diagnosis of acute respiratory failure (ARF) or acute on chronic respiratory failure (including patients having home oxygen therapy, HFNC, NIV) both hypercapnic ARF (PaCO2 > 45 mmHg; PaO2/FiO2 <300) or hypoxaemic (PaCO2 <45 mmHg; PaO2/FiO2 <300);
  • Informed consent from patient or legal tutor;
  • Accessory respiratory muscles use;
  • Respiratory rate above 25 apm;
  • Use of non invasive respiratory therapy (NIRT) NIV+/-HFNC or HFNC alone since RICU admission
  • Kelly neurological index ≤ 3
  • Excessive airway mucus secretion (clinical evaluation asking the patient to cough) and inability to efficiently remove secretions (evaluated with the Cough Peak Flow (CPF) measurement. A CPF under 270 Lpm is highly suggestive of inadequate cough which prevent the patient from adequately manage and remove airway secretions.
  • Cough score < 3: in the case of inability to perform CPF measurement due to poor patient collaboration, cough adequacy will be evaluated by a respiratory physiotherapy with a semiquantitative score ("Cough score") based on the measurement of sputum volume produced after coughing three times (1 point: less than 2 mL, 2 points: 2-6 mL, 3 points: more than 6 mL).

Who cannot join

  • Patient unwillingness or incapability to provide informed consent
  • Need for subcontinuous NIV(more than 20 hours per day)
  • Kelly neurological index >3
  • Cardiac arrest
  • Severe haemodynamic instability (more than two amines required);
  • acute coronary syndrome;
Show all 10Show fewer
  • Psychomotor agitation unresponsive to analgo-sedation (RASS> 1)
  • Contraindications to HFCWO use: acute pneumothorax (even if chest drainage is not required ); severe chest wall deformities (pectus excavatum, pectus carinatum or pectus arcuatum); severe obesity (BMI >40 kg/m2); pregnancy; thoracic or abdominal surgery in the six previous weeks
  • Nasal swab positivity to Sars-CoV-2
  • Need for endotracheal intubation or urgent bronchoscopy for excessive airway mucus

Trial locations and contacts

1 site in 1 country.

Raffaele Scala, MD contact

0575-255216

raffaele.scala@uslsudest.toscana.it

Italy1 site, 1 recruiting

  • Ospedale San Donato

    Arezzo, AR, 52100

    Raffaele Scala, MD, raffele.scala@uslsudest.toscana.it

    Recruiting

Other trials in Italy

About this study

Official title: The Role of HFCWO Via The Vest® Airway Clearance System in Addition to NIRT in the Treatment of Patient With Acute Respiratory Failure and Hypersecretion: Monocentric, Parallel Group, Controlled Randomized Clinical Trial

The study aims to evaluates if the treatment with HFCWO Via The Vest® Airway Clearance System, in addition to standard care in critically ill patients admitted in the Respiratory Intensive Care Unit for acute respiratory failure or acute on chronic respiratory failure and unable to manage secretions, could primarily prevent the need for bronchoscopy, and secondarily shorten duration of non invasive respiratory therapy, shorten length of stay and reduce mortality.

Being tested
High Frequency Chest Wall Oscillations via The Vest® Airway Clearance System
Keywords
Acute respiratory failure, NIRT, HFCWO, Airway hypersecretion, Non Invasive Ventilation, High Flow Nasal Cannulae

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High Frequency Chest Wall Oscillations via The Vest® Airway Clearance SystemDevice

    High Frequency Chest Wall Oscillations via The Vest® Airway Clearance System is a clinical device which consists in a pump which generates high frequency oscillations and connected to a jacket worn by the patient, intended to facilitate airway secretions clearance by detaching them from the bronchial wall and moving them upwards in the bronchial system.

Study groups in NCT05751707
Study groupRoleWhat they receive
NIV+/-HFNC (non invasive ventilation +/- high flow nasal cannulae) & HFCWOExperimentalPatient with acute or acute on chronic respiratory failure is treated with non invasive ventilation (with or without high flow nasal cannulae oxygen) AND High Frequency Chest Wall Oscillations
Receives: Device: High Frequency Chest Wall Oscillations via The Vest® Airway Clearance System
NIV+/-HFNC and no HFCWONo interventionPatient with acute or acute on chronic respiratory failure is treated with non invasive ventilation (with or without high flow nasal cannulae oxygen) AND NO High Frequency Chest Wall Oscillations
HFNC & HFCWOExperimentalPatient with acute or acute on chronic respiratory failure is treated with high flow nasal cannulae oxygen AND High Frequency Chest Wall Oscillations
Receives: Device: High Frequency Chest Wall Oscillations via The Vest® Airway Clearance System
HFNC and no HFCWONo interventionPatient with acute or acute on chronic respiratory failure is treated with high flow nasal cannulae oxygen AND High Frequency Chest Wall Oscillations

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of patients undergoing bronchoscopy

    Bronchoscopy is required when the patient is unable to spontaneously remove secretions despite physiokinesitherapy (Cough score < 3 and gas exchange deterioration during NIRT (PaO2/FiO2<200 or PaO2 <60 and/or PaCO2 increasement of 20%) and/or radiological worsening (development of lobar/multilobar/pulmonary atelectasis or pre-existing atelectasis worsening)

    Measured: From date of randomization until the date when the patients undergoes bronchoscopy becauase he/she is unable to spontaneously remove secretion assessed as worsening of gas exchange or of radiological appearance, whichever comes first, up to 30 days

Secondary outcomes (7)

  1. Days of non-invasive respiratory treatment (NIRT) duration

    Evaluates if reduction of NIRT duration in patients treated with HFCWO compared to patients treat only with NIRT, occurs

    Measured: From date of randomization until the date when the patient no more requires NIRT because of improving gas exchange, assessed up to 30 days (days)

  2. Days of RICU (respiratory intensive care unit) stay

    Evaluates if reduction of duration of RICU stay in patients treated with HFCWO compared to patients treat only with NIRT, occurs

    Measured: From date of randomization until the date when the patient is clinically stable to be discharged from RICU, assessed up to 30 days (days-weeks)

  3. Number of patients who undergo endotracheal intubation and Invasive mechanical ventilation

    Evaluates if reduction of need for Invasive mechanical ventilation in patients treated with HFCWO compared to patients treat only with NIRT, occurs

    Measured: From date of randomization until the date when the patient intubated for acute worsening of clinical conditions, assessed during hospital stay, up to 90 days

  4. Number of patients who undergo endotracheal intubation for inability to manage secretions in patients without a "do not resuscitate" (DNR) indication and RICU mortality for DNR patients

    Measured: From date of randomization until the date when the patient intubated for acute worsening of clinical conditions, assessed during hospital stay, up to 90 days

  5. Sputum volume

    Measured: 10 days

  6. Comfort in using The Vest airway clearance system in patients treated with HFCWO + NIRT

    Likert questionnaire scale will be used to assess this outcome

    Measured: 48 hours after HFCWO treatment starting

  7. Respiratory function tests 90 days after hospital discharge

    Measured: 90 days after hospital discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2023
  2. Study start24 Dec 2022
  3. Primary completion24 Dec 2024 (estimated)
  4. Study completion24 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Monocentric Parallel Group Controlled Randomized Clinical Trial
Masking
None (open label)
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05751707
Sponsor's protocol ID
VICOR2
Acronym
VICOR2
Status last verified
Feb 2023
First submitted
2 Feb 2023
Last updated
2 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Longhini F, Bruni A, Garofalo E, Ronco C, Gusmano A, Cammarota G, Pasin L, Frigerio P, Chiumello D, Navalesi P. Chest physiotherapy improves lung aeration in hypersecretive critically ill patients: a pilot randomized physiological study. Crit Care. 2020 Aug 3;24(1):479. doi: 10.1186/s13054-020-03198-6.

    PubMed 32746877

  • Mahajan AK, Diette GB, Hatipoglu U, Bilderback A, Ridge A, Harris VW, Dalapathi V, Badlani S, Lewis S, Charbeneau JT, Naureckas ET, Krishnan JA. High frequency chest wall oscillation for asthma and chronic obstructive pulmonary disease exacerbations: a randomized sham-controlled clinical trial. Respir Res. 2011 Sep 10;12(1):120. doi: 10.1186/1465-9921-12-120.

    PubMed 21906390

  • Nicolini A, Cardini F, Landucci N, Lanata S, Ferrari-Bravo M, Barlascini C. Effectiveness of treatment with high-frequency chest wall oscillation in patients with bronchiectasis. BMC Pulm Med. 2013 Apr 4;13:21. doi: 10.1186/1471-2466-13-21.

    PubMed 23556995

  • Celik M, Yayik AM, Kerget B, Kerget F, Doymus O, Aksakal A, Ozmen S, Aslan MH, Uzun Y. High-Frequency Chest Wall Oscillation in Patients with COVID-19: A Pilot Feasibility Study. Eurasian J Med. 2022 Jun;54(2):150-156. doi: 10.5152/eurasianjmed.2022.21048.

    PubMed 35703523

  • Scala R, Naldi M, Maccari U. Early fiberoptic bronchoscopy during non-invasive ventilation in patients with decompensated chronic obstructive pulmonary disease due to community-acquired-pneumonia. Crit Care. 2010;14(2):R80. doi: 10.1186/cc8993. Epub 2010 Apr 29.

    PubMed 20429929

  • Hall GJ, Gandevia B. Relationship of the loose cough sign to daily sputum volume. Observer variation in its detection. Br J Prev Soc Med. 1971 May;25(2):109-13. doi: 10.1136/jech.25.2.109. No abstract available.

    PubMed 5581051

  • Ielo S, Golfi N, Guidelli L, Arniani S, Vespi M, Tacconelli G, Preziosi N, Maccari U, Renda T, Scala R; of VICOR2 Investigators. High-Frequency Chest Wall Oscillation in Acute Respiratory Failure With Bronchial Hypersecretion: A Randomized Controlled Trial. Chest. 2026 Oct 14:S0012-3692(26)06807-8. doi: 10.1016/j.chest.2026.10.007. Online ahead of print.

    PubMed 42874912

Questions about this trial

What is this clinical trial studying?

A study testing High Frequency Chest Wall Oscillations via The Vest® Airway Clearance System in people with Acute Respiratory Failure and Acute-on-chronic Respiratory Failure, run by Raffaele Scala 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 8 inclusion and 10 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 2 Mar 2023. 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 Raffaele Scala, MD (0575-255216, raffaele.scala@uslsudest.toscana.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of patients undergoing bronchoscopy (time frame: From date of randomization until the date when the patients undergoes bronchoscopy becauase he/she is unable to spontaneously remove secretion assessed as worsening of gas exchange or of radiological appearance, whichever comes first, up to 30 days). 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 NCT05751707, which also lists 7 linked publications.

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 2 Mar 2023.

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