NCT06310941

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

Aspiration of Bronchial Secretions With Mechanical Insufflation-Exsufflation and Hypertonic Saline in Bacterial Nosocomial Tracheobronchitis and Pneumonia in Intubated Patients.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Hospital San Carlos, Madrid · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nosocomial Infection
• Nosocomial Pneumonia
• Tracheobronchitis
• Mechanical Ventilation Complication
• Endotracheal Intubation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-06-30
• Completion: 2027-12-30
• First posted: 2024-03-15
• Last updated: 2025-03-26

Locations

8 sites across 1 country: Spain