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

NCT06310941 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-03-26

No results posted yet for this 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.

Conditions

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

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

Sponsors & Collaborators

  • FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS

    collaborator OTHER

  • Hospital San Carlos, Madrid

    lead OTHER

Principal Investigators

  • Belén De la Hera Hernanz, PhD · Hospial Clinico San Carlos

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-06-30
Completion
2027-12-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06310941 on ClinicalTrials.gov