Prevention of Infection of the Respiratory Tract Through Application of Non-Invasive Methods of Secretion Suctioning
PIRAMIDES
A Randomized Controlled Pilot Trial Comparing 2 Non-invasive Airway Clearance Methods for the Prevention of Early-onset Ventilator-associated Pneumonia.
1 other identifier
interventional
60
1 country
1
Brief Summary
Severe trauma, head trauma, stroke and resuscitated cardiac arrest patients requiring endotracheal intubation and mechanical ventilation are at high risk of early-onset ventilator-associated pneumonia (EO-VAP). A short course of systemic antibiotic is recommended for prophylaxis. This study intends to assess the safety and efficacy of 2 alternative mechanical non-invasive airway clearance techniques in the prevention of EO-VAP in an open label randomized pilot trial of 20 subjects per study group i.e., 60 cases. The interventions will be in place for 7 days and the observational periods will be 14 days.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2023
CompletedFirst Posted
Study publicly available on registry
November 2, 2023
CompletedStudy Start
First participant enrolled
May 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 20, 2026
March 7, 2025
March 1, 2025
1.1 years
October 10, 2023
March 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence density of Respiratory tract infection per 1000 days of intubation
ventilator-associated pneumonia or tracheobronchitis
inclusion to day 14
Incidence of adverse events
Device-related complications
inclusion to day 14
Secondary Outcomes (3)
Duration of Respiratory support
inclusion until ICU discharge or death
Systemic antibiotic use
inclusion to day 14
Incidence and type of Bacterial resistance
14 days
Study Arms (3)
Standard of Care
ACTIVE COMPARATORIV ceftriaxone/24 hours 3 doses
Subglottic aspiration
EXPERIMENTALContinuos aspiration of subglottic secretions
Cough Simulator
EXPERIMENTALMechanical exsufflator
Interventions
mechanical suctioning of airway secretions
Eligibility Criteria
You may qualify if:
- Endotracheal intubation anticipated to last \>48 hours
- Stroke
- Severe Trauma
- Head Trauma
- Resuscitated cardiac arrest
You may not qualify if:
- Ominous prognosis
- Limitation of Life support
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Clinico San Carlos
Madrid, Madrid, 28040, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Manuel Alvarez-Gonzalez, MD.PhD
Hospial Clinico San Carlos
- PRINCIPAL INVESTIGATOR
Sandra Garcia Pintado, RN
Hospial Clinico San Carlos
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director Critical Care Department
Study Record Dates
First Submitted
October 10, 2023
First Posted
November 2, 2023
Study Start
May 19, 2025
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
December 20, 2026
Last Updated
March 7, 2025
Record last verified: 2025-03