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

Sponsor

Raffaele Scala (Other)

Overall Status

Recruiting

CT.gov ID

NCT05751707

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Failure Acute-on-chronic Respiratory Failure Airway Clearance Impairment	Device: High Frequency Chest Wall Oscillations via The Vest® Airway Clearance System	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Monocentric Parallel Group Controlled Randomized Clinical TrialMonocentric Parallel Group Controlled Randomized Clinical Trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Dec 24, 2022

Anticipated Primary Completion Date :

Dec 24, 2024

Anticipated Study Completion Date :

Dec 24, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Rate of patients undergoing bronchoscopy [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]
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)

Secondary Outcome Measures

Days of non-invasive respiratory treatment (NIRT) duration [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)]
Evaluates if reduction of NIRT duration in patients treated with HFCWO compared to patients treat only with NIRT, occurs
Days of RICU (respiratory intensive care unit) stay [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)]
Evaluates if reduction of duration of RICU stay in patients treated with HFCWO compared to patients treat only with NIRT, occurs
Number of patients who undergo endotracheal intubation and Invasive mechanical ventilation [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]
Evaluates if reduction of need for Invasive mechanical ventilation in patients treated with HFCWO compared to patients treat only with NIRT, occurs
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 [48 hours after HFCWO treatment starting]
Likert questionnaire scale will be used to assess this outcome
Respiratory function tests 90 days after hospital discharge [90 days after hospital discharge]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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