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VICOR Study-High Frequency Chest Wall Oscillations (HFCWO) in Patients With Acute Respiratory Failure and Hypersecretion | Clinical Trials | Clareo Health

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

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

NCT05751707•Raffaele Scala

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (1)

Ospedale San Donato

Arezzo, AR, Italy

Key Dates

Start Date

December 24, 2022

Primary Completion Date

December 24, 2024

Completion Date

December 24, 2024

Last Updated

March 2, 2023

Enrollment

ESTIMATED participants

Conditions

Acute Respiratory FailureAcute-on-chronic Respiratory FailureAirway Clearance Impairment

Interventions

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

DEVICE

Contacts

Raffaele Scala, MD

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Outcome Comparisons of Vibratory Airway Clearance Devices

Global Physiotherapy in ICU Patients With High Risk Extubation Failure

Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure

Waveform Capnography Compared to Colorimetric Carbon Dioxide Detection During Tracheal Intubation of Critically Ill Adults

Closed Loop Oxygen Control in INtubated Critically Ill Patients

Effects of Ventilator Hyperinflation Versus Vibrocompression in Mechanically Ventilated Patients