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NOT YET RECRUITING
NCT06310941
NA

Mechanical Insufflation-exsufflation and Hypertonic Saline in Nosocomial Bacterial Respiratory Tract Infection

Sponsor: Hospital San Carlos, Madrid

View on ClinicalTrials.gov

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

Interventions

DEVICE

Mechanical insufflation-exsufflation

Combined use of mechanical insufflation-exsufflation with nebulized hypertonic saline in intubated patients with nosocomial respiratory tract infection

OTHER

Standard of Care

systemic antibiotic therapy and catheter suctioning of secretions as recommended by guidelines

OTHER

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