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

Raffaele Scala

Status: Enrolling

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05751707

VICOR2

Details and patient eligibility

About

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.

Enrollment: 88 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 4 patient groups

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

Experimental group

Description:

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

Treatment:

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

NIV+/-HFNC and no HFCWO

No Intervention group

Description:

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 group

Description:

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

Treatment:

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

HFNC and no HFCWO

No Intervention group

Description:

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