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

NCT05751707 | Unknown

• 1 other identifier: VICOR2
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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 prevent the need for bronchoscopy, and secondarily shorten duration of non invasive respiratory therapy, shorten length of stay and reduce mortality.

Conditions

Acute Respiratory Failure; Acute-on-chronic Respiratory Failure; Airway Clearance Impairment

Keywords

Acute respiratory failure; NIRT; HFCWO; Airway hypersecretion; Non Invasive Ventilation; High Flow Nasal Cannulae

Outcome Measures

Primary Outcomes (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)

  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)

• Days of non-invasive respiratory treatment (NIRT) duration

  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)

• Days of RICU (respiratory intensive care unit) stay

  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)

• Number of patients who undergo endotracheal intubation and Invasive mechanical ventilation

  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

• 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

  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

• Sputum volume

  10 days

Study Arms (4)

NIV+/-HFNC (non invasive ventilation +/- high flow nasal cannulae) & HFCWO

EXPERIMENTAL

Patient 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

Device: High Frequency Chest Wall Oscillations via The Vest® Airway Clearance System

NIV+/-HFNC and no HFCWO

NO INTERVENTION

Patient 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 & HFCWO

EXPERIMENTAL

Patient with acute or acute on chronic respiratory failure is treated with high flow nasal cannulae oxygen AND High Frequency Chest Wall Oscillations

Device: High Frequency Chest Wall Oscillations via The Vest® Airway Clearance System

HFNC and no HFCWO

NO INTERVENTION

Patient with acute or acute on chronic respiratory failure is treated with high flow nasal cannulae oxygen AND High Frequency Chest Wall Oscillations

Interventions

High Frequency Chest Wall Oscillations via The Vest® Airway Clearance System DEVICE

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.

HFNC & HFCWO; NIV+/-HFNC (non invasive ventilation +/- high flow nasal cannulae) & HFCWO

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• Raffaele Scala: lead

Study Sites (1)

Ospedale San Donato

Arezzo, AR, 52100, Italy

RECRUITING

Related Publications (6)

• 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.

  PMID: 32746877 RESULT

• 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.

  PMID: 21906390 RESULT

• 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.

  PMID: 23556995 RESULT

• 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.

  PMID: 35703523 RESULT

• 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.

  PMID: 20429929 RESULT

• 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.

  PMID: 5581051 RESULT

Central Study Contacts

Raffaele Scala, MD

CONTACT

0575-255216; raffaele.scala@uslsudest.toscana.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Respiratory Intensive Care Unit

Model Details: Monocentric Parallel Group Controlled Randomized Clinical Trial

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: March 2, 2023
• Study Start: December 24, 2022
• Primary Completion: December 24, 2024
• Study Completion: December 24, 2024
• Last Updated: March 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)