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

Acute Respiratory Failure Clinical Trial

— VICOR2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05751707
• Other study ID #: VICOR2
• Status: Recruiting
• Phase: N/A
• Start date: December 24, 2022
• Est. completion date: December 24, 2024

Study information

• Verified date: February 2023
• Source: Ospedale San Donato
• Contact: Raffaele Scala, MD
• Phone: 0575-255216
• Email: raffaele.scala[@]uslsudest.toscana.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: December 24, 2024
• Est. primary completion date: December 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Acute-on-chronic Respiratory Failure
• Airway Clearance Impairment
• Respiratory Distress Syndrome
• Respiratory Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Italy	Ospedale San Donato	Arezzo	AR

Sponsors (1)

Lead Sponsor	Collaborator
Raffaele Scala

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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 — View Citation

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. — View Citation

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 A — View Citation

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 ra — View Citation

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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	Sputum volume		10 days
Secondary	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
Secondary	Respiratory function tests 90 days after hospital discharge		90 days after hospital discharge