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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• 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

Trial sites (8)

More Hospital San Carlos, Madrid trials in Spain

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