Last updated: February 25, 2023
Sponsor: Raffaele Scala
Overall Status: Active - Recruiting
Phase
N/A
Condition
Lung Injury
Acute Respiratory Distress Syndrome (Ards)
Respiratory Failure
Treatment
N/AClinical Study ID
NCT05751707
VICOR2
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 RICUadmission
- Kelly neurological index ≤ 3
- Excessive airway mucus secretion (clinical evaluation asking the patient to cough) andinability to efficiently remove secretions (evaluated with the Cough Peak Flow (CPF)measurement. A CPF under 270 Lpm is highly suggestive of inadequate cough whichprevent the patient from adequately manage and remove airway secretions.
- Cough score < 3: in the case of inability to perform CPF measurement due to poorpatient collaboration, cough adequacy will be evaluated by a respiratory physiotherapywith a semiquantitative score ("Cough score") based on the measurement of sputumvolume produced after coughing three times (1 point: less than 2 mL, 2 points: 2-6 mL, 3 points: more than 6 mL).
Exclusion
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 notrequired ); severe chest wall deformities (pectus excavatum, pectus carinatum orpectus arcuatum); severe obesity (BMI >40 kg/m2); pregnancy; thoracic or abdominalsurgery in the six previous weeks
- Nasal swab positivity to Sars-CoV-2
- Need for endotracheal intubation or urgent bronchoscopy for excessive airway mucus
Study Design
Total Participants: 88
Study Start date:
December 24, 2022
Estimated Completion Date:
December 24, 2024
Connect with a study center
Ospedale San Donato
Arezzo, AR 52100
ItalyActive - Recruiting
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