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

Sponsor
Hospital San Carlos, Madrid
Study ID
NCT06113939
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • airway clearance — DEVICE
    mechanical suctioning of airway secretions

Study Details

Adults who are unconscious or severely ill and need a breathing tube connected to a ventilator are at high risk of developing a lung infection (pneumonia) within the first few days in the intensive care unit. This early pneumonia affects up to 30 to 50 % of certain high-risk patients, prolongs the time on the ventilator and in hospital, and increases the use of antibiotics. Two strategies are commonly used today to try to prevent this infection: a short, three-day course of an intravenous antibiotic, and removal of secretions from the airway with a sterile suction catheter. Both have limitations - antibiotics can favour the growth of resistant bacteria, and catheter suctioning is uncomfortable and may injure the airway. PIRÁMIDES is a small (60-patient) pilot study that compares the current practice with two non-invasive, mechanical alternatives for keeping the airway clear: a continuous low-pressure suction system built into a special breathing tube, and a device that produces a gentle, programmed "artificial cough" through the ventilator. Adult patients who are intubated for severe trauma, severe brain injury, stroke, resuscitated cardiac arrest or other causes of decreased consciousness are randomly assigned, in equal numbers, to one of the three approaches and followed for 14 days, with a final visit at day 90. The main goal is to find out which of the three strategies best prevents early pneumonia, and which provides the best overall result for patients when survival, severity of infection, need for additional antibiotics and side effects are considered together. To make these comparisons as fair as possible in an open-label study, an independent committee of doctors not involved in patient care reviews each suspected pneumonia case without knowing which strategy the patient received. The results will help design a larger trial to confirm which approach is safest and most effective for preventing early pneumonia in critically ill patients on a ventilator.

Key Dates

First listed
Nov 2, 2023
Start date
Sep 15, 2026
Status verified
Jun 2026
Primary completion
Dec 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Standard of Care
    IV ceftriaxone/24 hours 3 doses
  • Experimental: Subglottic aspiration
    Continuos aspiration of subglottic secretions
  • Experimental: Cough Simulator
    Mechanical exsufflator

Primary Outcome Measure

Incidence density of Respiratory tract infection per 1000 days of intubation [ Time Frame: inclusion to day 14 ]

Central Contacts

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