Testing ways to prevent lung infection in patients on breathing machines

Trial details

Who runs it

Hospital San Carlos, Madrid

Trial code

NCT06113939EU 2025-521454-42-00

Record updated

6 August 2026

Original description

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.Read full original descriptionShow less

Prevention of Infection of the Respiratory Tract by Applying Methods That Are Non-Invasive for Extraction of Secretions. An Open Label, Randomized, Assessor-blinded Trial.

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.

Inclusion: Endotracheal intubation with an anticipated duration > 48 hours; High risk of early respiratory infection associated with a diagnosis of:; Severe trauma; Severe traumatic brain injury; Ischaemic or haemorrhagic stroke; Other causes of impaired consciousness: post-resuscitated cardiac arrest status, intoxications, acute infections or diseases of the central nervous system, seizures; Informed consent signed by the patient or, when impossible due to clinical status, by their legal representative, with re-consent by the patients themselves upon regaining capacity (section 15).

Exclusion: Already established indication for systemic antibiotic therapy, either for suspected aspiration pneumonia with radiological pulmonary infiltrate or for suspected non-respiratory source infection; Active haemoptysis or pulmonary haemorrhage; Known allergy or intolerance to beta-lactam antibiotics; Intubation with an anticipated duration < 48 hours; Foreseeable ominous prognosis within < 7 days; Unstable chest; Undrained pneumothorax (inclusion may be considered once drained).

ClinicalTrials.gov NCT06113939 · EU CTIS 2025-521454-42-00