Acute-on-chronic Respiratory Failure, Acute Respiratory Failure, Airway Clearance Impairment
Conditions
Keywords
Acute respiratory failure, NIRT, HFCWO, Airway hypersecretion, Non Invasive Ventilation, High Flow Nasal Cannulae
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.
Interventions
DEVICEHigh 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.
Sponsors
Raffaele Scala
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Monocentric Parallel Group Controlled Randomized Clinical Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 |
| 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 | — |
| Sputum volume | 10 days | — |
Countries
Italy
Contacts
Primary ContactRaffaele Scala, MD
Outcome results
None listed