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

Study acronym: ABSENTA
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary completion date: Oct 30, 2026 to Jun 30, 2027v3 Show 6 more changesShow less
    • Start date: Dec 1, 2024 to Jan 1, 2026
    • Study sites: 7 to 8
    • Study completion date: Dec 30, 2026 to Dec 30, 2027
    • Study description expanded, about 134 words
    • Collaborators expanded, about 8 words
    • Eligibility criteria expanded, about 5 words
  2. Minor Study sites: 0 to 7
    • Eligibility criteria revised
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06310941
Lead Sponsor Hospital San Carlos, Madrid
Collaborators: FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS
Conditions
(from sponsor)
Nosocomial Infection, Nosocomial Pneumonia, Tracheobronchitis, Mechanical Ventilation Complication, Endotracheal Intubation
Related terms Cross Infection, Healthcare-Associated Pneumonia, Pneumonia, Ventilator-Associated
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov