Endotracheal Intubation, Mechanical Ventilation Complication, Nosocomial Infection, Nosocomial Pneumonia, Tracheobronchitis
Conditions
Keywords
mechanical insufflation-exsufflation, cough assist device, hypertonic saline, nosocomial respiratory tract infection, hospital-acquired pneumonia, tracheobronchitis, ventilator-associated pneumonia, nebulization
Brief summary
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.
Detailed description
Open label, randomized, multicenter (7 ICUs at 7 hospitals in Spain). The study has 2 main arms, pneumonia and tracheobronchitis. If the diagnosis is pneumonia, subjects will be randomization to one of 3 study groups: 1. IV Antibiotic therapy 2. IV Antibiotic therapy + mechanical insufflation-Exsugglation (MI-E) 3. IV Antibiotic therapy + MI-E + nebulized hypertonic saline-hyaluronic acid (HS) If the diagnosis is tracheobronchitis,subjects will be randomization to one of 3 study groups: 1. No specific therapy (recommendation of the Infectious Diseases Society of America) 2. IV Antibiotic therapy (common practice to prevent progressión to pneumona and shorten duration of intubation) 3. MI-E + HS Safety will be compared by number of adverse events, severe adverse events and mortality between study groups in each main arm. Efficacy will be compared by duration of respiratory support and number of cases with worsening organ dysfunction.
Interventions
Combined use of mechanical insufflation-exsufflation with nebulized hypertonic saline in intubated patients with nosocomial respiratory tract infection
OTHERStandard of Care
systemic antibiotic therapy and catheter suctioning of secretions as recommended by guidelines
OTHERHypertonic saline with hyaluronic acid
Commercially available combination of 7% hypertonic saline with 0.1% hyaluronic acid given as nebulization during the MI-E session
Sponsors
FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS
Hospital San Carlos, Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
multicenter, randomized, open label
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent * Nosocomial pneumonia (vHAP or VAP) or nosocomial tracheobronchitis * Intubated with a cuffed endotracheal tube or tracheostomy cannula.
Exclusion criteria
* Ominous prognosis * Frank hemoptisis * Barotrauma (pneumothorax or pneumomediastinum) * Bronchospasm (patients on bronchodilators for previous bronchospasm may be included * Unstable thoracic cage * Suspected unmonitored intracraneal hypertension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median SOFA score increase >2 points on day 4 | inclusion to day 4 after randomization | Increase in organ dysfunction score from baseline to day 4 after randomization. |
| Median respiratory support-free days increase at day 28 | Inclusion to day 28 after randomization | 28 minus duration in days on high-flow nasal cannula + invasive ventilation. |
| Percentage of subjects surviving/dying day 28 | Inclusion to day 28 after randomization | crude mortality on day 28 after randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjects with bacterial eradication in respiratory samples at day 4 after randomization | Day 3 to 5 after randomization | Negative tests for causal microorganism in day 4 samples |
| Median antibiotic-free days at 28 days | from study inclusion to day 28 | 28 minus days without systemic antibiotic therapy |
| Subjects with bacterial eradication in respiratory samples at end of systemic antibiotic therapy | 7 and 14 days after randomization | Negative culture and molecular test for causative bacteria in samples at end of therapy |
| Median Length of ICU stay | ICU admission to discharge or death in days | Duration of ICU stay from admission to discharge or death |
Countries
Spain
Contacts
Primary ContactMiguel Sánchez Garcia, MD. PhD.
Backup ContactBelén De la Hera Hernanz, PhD
Outcome results
None listed