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

Summary

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.

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 by creating a high expiratory peak flow

DEVICE

subglottic secretion aspiration

A specialized endotracheal tube with an aspiration channel dragging secretions accumulating above the cuff

DRUG

Ceftriaxone 2 grams daily

standard of care for prevention of early VAP according to Spanish recommendations (Zero Pneumonia Project)

Sponsors & Collaborators

• SAMUR-Protección Civil, Madrid, Spain

  collaborator UNKNOWN

• 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

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-15

Primary Completion

2028-12-30

Completion

2029-06-30

Countries

• Spain

Study Locations