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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-24

Study Completion Date

2024-12-24

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Monocentric Parallel Group Controlled Randomized Clinical Trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

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

Intervention Type 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.

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

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

Intervention Type 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 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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No