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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital San Carlos, Madrid

About this trial

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 criteria

Qualifiers

Signed informed consent

Nosocomial pneumonia (vHAP or VAP) or nosocomial tracheobronchitis

Intubated with a cuffed endotracheal tube or tracheostomy cannula.

Disqualifiers

Ominous prognosis

Frank hemoptisis

Barotrauma (pneumothorax or pneumomediastinum)

Bronchospasm (patients on bronchodilators for previous bronchospasm may be included

Trial design

Treatments tested in this trial

  • Mechanical insufflation-exsufflation
  • Standard of Care
  • Hypertonic saline with hyaluronic acid

Treatment groups

100 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Hospital San Carlos, Madrid

Lead sponsor

FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS

Collaborator