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Prevention of Infection of the Respiratory Tract Through Application of Non-Invasive Methods of Secretion Suctioning

NCT06113939 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-03-07

No results posted yet for this study

Summary

Severe trauma, head trauma, stroke and resuscitated cardiac arrest patients requiring endotracheal intubation and mechanical ventilation are at high risk of early-onset ventilator-associated pneumonia (EO-VAP). A short course of systemic antibiotic is recommended for prophylaxis.

This study intends to assess the safety and efficacy of 2 alternative mechanical non-invasive airway clearance techniques in the prevention of EO-VAP in an open label randomized pilot trial of 20 subjects per study group i.e., 60 cases. The interventions will be in place for 7 days and the observational periods will be 14 days.

Conditions

  • Intubation Complication
  • Stroke, Ischemic
  • Stroke Hemorrhagic
  • Head Trauma
  • Cardiac Arrest
  • Ventilator Associated Pneumonia
  • Airway Clearance Impairment

Interventions

DEVICE

airway clearance

mechanical suctioning of airway secretions

Sponsors & Collaborators

  • Hospital San Carlos, Madrid

    lead OTHER

Principal Investigators

  • Manuel Alvarez-Gonzalez, MD.PhD · Hospial Clinico San Carlos

  • Sandra Garcia Pintado, RN · Hospial Clinico San Carlos

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-19
Primary Completion
2026-06-30
Completion
2026-12-20

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 NCT06113939 on ClinicalTrials.gov