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

Raffaele Scala88 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Time frame: 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 Outcomes

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

Time frame: 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)

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

Time frame: 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)

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

Time frame: 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

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

Time frame: 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

Time frame: 10 days

Comfort in using The Vest airway clearance system in patients treated with HFCWO + NIRT

Likert questionnaire scale will be used to assess this outcome

Time frame: 48 hours after HFCWO treatment starting

Respiratory function tests 90 days after hospital discharge

Time frame: 90 days after hospital discharge