Multicenter, randomized open label clinical trial to evaluate IEM and HS as concomitant therapy for respiratory tract infection in patients under artificial ventilation in the ICU.
Lung infection is a serious complication that may occur during hospital stay and may need artificial respiration or even develop during artificial ventilation for other causes.
Current specific treatment consists of intravenous antibiotics. The current study evaluated whether aspiration and drainage of infected sputum helps curing this severe complication and whether nebulized HS has additional benefits, like loosening of secretions, eradicating bacteria or reducing inflammation.
Signed informed consent
Nosocomial pneumonia (vHAP or VAP) or nosocomial tracheobronchitis
Intubated with a cuffed endotracheal tube or tracheostomy cannula.
Ominous prognosis
Frank hemoptisis
Barotrauma (pneumothorax or pneumomediastinum)
Bronchospasm (patients on bronchodilators for previous bronchospasm may be included
Parallel
Mechanical insufflation-exsufflation
DeviceCombined use of mechanical insufflation-exsufflation with nebulized hypertonic saline in intubated patients with nosocomial respiratory tract infection
Standard of Care
Other interventionsystemic antibiotic therapy and catheter suctioning of secretions as recommended by guidelines
Hypertonic saline with hyaluronic acid
Other interventionCommercially available combination of 7% hypertonic saline with 0.1% hyaluronic acid given as nebulization during the MI-E session
Median SOFA score increase >2 points on day 4
Increase in organ dysfunction score from baseline to day 4 after randomization.
Median respiratory support-free days increase at day 28
28 minus duration in days on high-flow nasal cannula + invasive ventilation.
Percentage of subjects surviving/dying day 28
crude mortality on day 28 after randomization
Subjects with bacterial eradication in respiratory samples at day 4 after randomization
Negative tests for causal microorganism in day 4 samples
Subjects with bacterial eradication in respiratory samples at end of systemic antibiotic therapy
Negative culture and molecular test for causative bacteria in samples at end of therapy
Median Length of ICU stay
Duration of ICU stay from admission to discharge or death
Median antibiotic-free days at 28 days
28 minus days without systemic antibiotic therapy
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Hospital San Carlos, Madrid
Lead sponsor
FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
