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Mechanical Insufflation-exsufflation and Hypertonic Saline in Nosocomial Bacterial Respiratory Tract Infection
Sponsor: Hospital San Carlos, Madrid
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.
Official title: Aspiration of Bronchial Secretions With Mechanical Insufflation-Exsufflation and Hypertonic Saline in Bacterial Nosocomial Tracheobronchitis and Pneumonia in Intubated Patients.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-01-01
Completion Date
2027-12-30
Last Updated
2025-03-26
Healthy Volunteers
No
Conditions
Interventions
Mechanical insufflation-exsufflation
Combined use of mechanical insufflation-exsufflation with nebulized hypertonic saline in intubated patients with nosocomial respiratory tract infection
Standard of Care
systemic antibiotic therapy and catheter suctioning of secretions as recommended by guidelines
Hypertonic saline with hyaluronic acid
Commercially available combination of 7% hypertonic saline with 0.1% hyaluronic acid given as nebulization during the MI-E session
Locations (8)
Hospital Vall d´Hebrón.
Barcelona, Barcelona, Spain
Hospital Nuestra Señora de la Candelaria.
Santa Cruz de Tenerife, Las Palmas, Spain
Hospital Clinico San Carlos
Madrid, Madrid, Spain
Hospital Clínico San Carlos
Madrid, Madrid, Spain
Hospital de la Princesa
Madrid, Madrid, Spain
Hospital Doce de Octubre
Madrid, Madrid, Spain
Hospital Álvaro Cunqueiro.
Vigo, Pontevedra, Spain
Virgen de la Salud
Toledo, Toledo, Spain