VICOR Study-High Frequency Chest Wall Oscillations (HFCWO) in Patients With Acute Respiratory Failure and Hypersecretion (VICOR2)

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Respiratory Failure; Airway Clearance Impairment; Acute-on-chronic Respiratory Failure
• Intervention / Treatment: Device: High Frequency Chest Wall Oscillations via The Vest® Airway Clearance System

• Study Type: Interventional
• Enrollment (Anticipated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raffaele Scala, MD; Phone Number: 0575-255216; Email: raffaele.scala@uslsudest.toscana.it

Study Locations

• Italy
  • AR
    • Arezzo, AR, Italy, 52100
      • Recruiting
      • Ospedale San Donato
      • Contact: Raffaele Scala, MD; Email: raffele.scala@uslsudest.toscana.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NIV+/-HFNC (non invasive ventilation +/- high flow nasal cannulae) & HFCWO; 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; 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.
No Intervention: NIV+/-HFNC and no HFCWO; 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
Experimental: HFNC & HFCWO; 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; 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.
No Intervention: HFNC and no HFCWO; Patient with acute or acute on chronic respiratory failure is treated with high flow nasal cannulae oxygen AND High Frequency Chest Wall Oscillations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Evaluates if reduction of duration of RICU stay in patients treated with HFCWO compared to patients treat only with NIRT, occurs	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	Evaluates if reduction of need for Invasive mechanical ventilation in patients treated with HFCWO compared to patients treat only with NIRT, occurs	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
Comfort in using The Vest airway clearance system in patients treated with HFCWO + NIRT	Likert questionnaire scale will be used to assess this outcome	48 hours after HFCWO treatment starting
Respiratory function tests 90 days after hospital discharge		90 days after hospital discharge

Collaborators and Investigators

• Sponsor: Raffaele Scala

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 24, 2022
• Primary Completion (Anticipated): December 24, 2024
• Study Completion (Anticipated): December 24, 2024

Study Registration Dates

• First Submitted: February 2, 2023
• First Submitted That Met QC Criteria: February 25, 2023
• First Posted (Actual): March 2, 2023

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: February 25, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Acute respiratory failure; Non Invasive Ventilation; HFCWO; High Flow Nasal Cannulae; NIRT; Airway hypersecretion
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Respiratory Insufficiency; Respiratory Distress Syndrome
• Other Study ID Numbers: VICOR2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No