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.
Endotracheal intubation with an anticipated duration > 48 hours.
Severe trauma.
Severe traumatic brain injury.
Ischaemic or haemorrhagic stroke.
Intubation with an anticipated duration < 48 hours.
Foreseeable ominous prognosis within < 7 days.
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.
Parallel
airway clearance
Devicemechanical suctioning of airway secretions by creating a high expiratory peak flow
subglottic secretion aspiration
DeviceA specialized endotracheal tube with an aspiration channel dragging secretions accumulating above the cuff
Ceftriaxone 2 grams daily
Drugstandard of care for prevention of early VAP according to Spanish recommendations (Zero Pneumonia Project)
Incidence density of Respiratory tract infection per 1000 days of intubation
ventilator-associated pneumonia or tracheobronchitis
Desirability of Outcome Ranking
Global ordinal comparison of the five DOOR categories across the three arms
Systemic antibiotic use
Number of patients needing antibiotic therapy for respiratory tract infection and antimicrobial DDDs
Incidence and type of Bacterial resistance
Identification of resistance bacteria in respiratory tract samples
bacterial tracheobronchitis
Diagnostic criteria for VAP without lung infiltrate nor significant worsening of oxygenation
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Hospital San Carlos, Madrid
Lead sponsor
SAMUR-Protección Civil, Madrid, Spain
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
