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

NCT06113939 | Not Yet Recruiting Phase 4 DMC

• 2 other identifiers: PIRAMIDES2025-521454-42-00
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

ventilator-associated pneumonia; prevention; airway clearance

Outcome Measures

Primary Outcomes (1)

• Incidence density of Respiratory tract infection per 1000 days of intubation

  ventilator-associated pneumonia or tracheobronchitis

  inclusion to day 14

Secondary Outcomes (10)

• Desirability of Outcome Ranking

  Outcome category asigned at Day 14

• Systemic antibiotic use

  inclusion to day 14

• Incidence and type of Bacterial resistance

  14 days

• bacterial tracheobronchitis

  From inclusion to day 14

• ventilator-free and respiratory-support-free days

  From inclusion to day 14

Study Arms (3)

Standard of Care

ACTIVE COMPARATOR

Ceftriaxone/24 hours 3 intravenous doses

Drug: Ceftriaxone 2 grams daily

Cough Simulator

EXPERIMENTAL

Mechanical exsufflator

Device: airway clearance

subglottic secretion aspiration

EXPERIMENTAL

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

Device: subglottic secretion aspiration

Interventions

airway clearance DEVICE

mechanical suctioning of airway secretions by creating a high expiratory peak flow

Cough Simulator

subglottic secretion aspiration DEVICE

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

subglottic secretion aspiration

Ceftriaxone 2 grams daily DRUG

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

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• Unstable chest.
• Known allergy or intolerance to beta-lactam antibiotics.

Sponsors & Collaborators

• Hospital San Carlos, Madrid: lead
• SAMUR-Protección Civil, Madrid, Spain: collaborator

Study Sites (1)

Hospital Clinico San Carlos

Madrid, Madrid, 28040, Spain

Location

Related Publications (20)

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MeSH Terms

Conditions

Ischemic Stroke; Hemorrhagic Stroke; Craniocerebral Trauma; Heart Arrest; Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Trauma, Nervous System; Wounds and Injuries; Heart Diseases; Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Manuel Alvarez-Gonzalez, MD.PhD

  Hospial Clinico San Carlos

  STUDY DIRECTOR

• Sandra Garcia Pintado, RN

  Hospial Clinico San Carlos

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miguel Sánchez Garcia, MD. PhD.

CONTACT

+34658762739; miguelsanchez.hcsc@gmail.com

Belén belenhhernanz@gmail.com, PhD

CONTACT

+34658762739

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emeritus Director Critical Care Department

Model Details: Open label, randomized, assessor-blinded (evaluation committee unaware of study group allocation)

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: November 2, 2023
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From publication of study onwards. No time limit.
• Access Criteria: Contact with central contact person or principal investigator.

Locations

ES (1)