A Phase 4 interventional study of airway clearance and subglottic secretion aspiration in Intubation Complication, Stroke, Ischemic and Stroke Hemorrhagic, sponsored by Hospital San Carlos, Madrid. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Hospital San Carlos, Madrid · Phase 4, Interventional, and Prevention
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.
Background. Patients with structural coma are at high risk of so-called early onset pneumonia (EOP). Incidence rates of up to 50% have been reported in patients with head trauma or stroke. The usual causative microorganisms belong to the normal upper airway flora like Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenza and Moraxella catarrhalis. EOP typically is not present at admission and develops after 2 to 7 days after endotracheal intubation.
A short course of systemic antibiotic therapy and aspiration of subglottic secretions (ASS) are associated with significant reductions in EOP, although ASS does not prevent late-onset pneumonia. Non-invasive mechanical methods may avoid the use of prophylactic antibiotics and pain and injury to the tracheal mucosa caused by the conventional suctioning catheter.
PIRÁMIDES is a single-centre, open-label, randomised controlled trial (1:1:1) comparing three approved strategies for the prevention of early-onset ventilator-associated pneumonia (early VAP) in adult intubated patients at high risk of this complication (severe trauma, severe traumatic brain injury, ischaemic or haemorrhagic stroke, post-cardiac-arrest syndrome and other acute causes of decreased consciousness). Sixty patients (20 per arm) are recruited at the Critical Care Department of Hospital Clínico San Carlos (Madrid, Spain). The trial compares the standard 3-day short antibiotic course (ceftriaxone 2 g IV every 24 h) plus sterile-catheter suctioning, continuous subglottic secretion suctioning for 7 days through a dedicated endotracheal-tube channel, and 7 days of programmed sessions of a CE-marked bionic cough simulator (BCS3, Yaguo). The unit-standard topical selective digestive decontamination regimen is applied in all three arms. Intervention duration is 7 days, the main observation period extends to day 14 and final outcomes are collected at day 90. Because the interventions are visually distinct at the bedside, the trial is open-label for the treating team and patients.
The current protocol version (v2.0, April 2026) incorporates two substantial amendments. First, the objectives have been restructured: a single primary endpoint, the cumulative incidence of bacterial early VAP through day 14, replaces the original co-primary structure, and a hierarchical "Desirability of Outcome Ranking" (DOOR) endpoint at day 14 is introduced as the key secondary endpoint. The DOOR endpoint is applied identically to the three arms and integrates, in a clinically ordered five-category hierarchy, mortality, the occurrence and severity of VAP, exposure to rescue antibiotics and serious intervention-related adverse events. Categories range from (1) alive at day 14 without VAP, rescue antibiotic or related serious adverse event, to (5) death before day 14, with intermediate categories for rescue-antibiotic use without confirmed VAP, non-severe VAP, and severe VAP or major intervention-related complication.
Second, the amendment establishes an independent blinded Adjudication Committee (two intensivists specialized in ICU-acquired infections external to the trial team, one chest radiologist and one microbiologist) responsible for the final classification of every potential pneumonia episode and for the assignment of each patient to the corresponding DOOR category. The Committee reviews case-report forms, chest radiographs and lung ultrasound images, microbiology reports and other relevant clinical documentation, with all fields identifying the assigned arm removed or masked; decisions are reached by consensus.
The trial effect estimates and 95 % confidence intervals are exploratory and hypothesis-generating. The primary endpoint is analyzed in the intention-to-treat population by Fisher's exact test. The DOOR endpoint is analyzed in two pre-specified steps: a global ordinal comparison across the three arms using a proportional-odds model, followed by pairwise win-ratio comparisons on the same pre-specified hierarchy, with win odds as a sensitivity analysis and a pre-specified continuous tiebreaker (ventilator-free days through day 14, then ICU length of stay) where ties are abundant. Multiplicity between the two main pairwise comparisons (each mechanical strategy versus control) is addressed through a hierarchical testing procedure pre-specified in the Statistical Analysis Plan. A pre-specified electrical impedance tomography sub-study in five patients per arm explores the acute effects of each strategy on regional ventilation and compliance.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 60 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Hospital San Carlos, Madrid is the lead sponsor of 74 studies on the registry; 17 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
High risk of early respiratory infection associated with a diagnosis of:
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ceftriaxone/24 hours 3 intravenous doses
Drug: Ceftriaxone 2 grams daily
Mechanical exsufflator
Device: airway clearance
a specialized endotracheal tube with an aspiration channel dragging secretions accumulating above the cuff outward
Device: subglottic secretion aspiration
mechanical suctioning of airway secretions by creating a high expiratory peak flow
A specialized endotracheal tube with an aspiration channel dragging secretions accumulating above the cuff
standard 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
Time frame: inclusion to day 14
Desirability of Outcome Ranking
Global ordinal comparison of the five DOOR categories across the three arms
Time frame: Outcome category asigned at Day 14
Systemic antibiotic use
Number of patients needing antibiotic therapy for respiratory tract infection and antimicrobial DDDs
Time frame: inclusion to day 14
Incidence and type of Bacterial resistance
Identification of resistance bacteria in respiratory tract samples
Time frame: 14 days
bacterial tracheobronchitis
Diagnostic criteria for VAP without lung infiltrate nor significant worsening of oxygenation
Time frame: From inclusion to day 14
ventilator-free and respiratory-support-free days
Disconnected from ventilator and days without any respiratory support (invasive + non-invasive mechanical ventilation + high-flow nasal cannula) by day 14 of inclusion.
Time frame: From inclusion to day 14
ICU and hospital length of stay
Days from admission to ICU to discharge from ICU and hospital.
Time frame: From inclusion to day 90
Mortality at late follow-up
Vital status on day 90 of inclusion
Time frame: From inclusion to day 90
modified Rankin score
Quality of life and vital status at late follow-up day 90
Time frame: Day 90
number of catheter suctioning episodes
Sterile catheter suctioning needs in all study arms
Time frame: From inclusion to day 7
Antimicrobial exposure endpoints: antibiotic-free days, use of rescue antibiotics, isolation of clinically relevant resistant organisms on day 14.
Ecological impact assessment
Time frame: From inclusion to day 14
Plan to share: Yes — Upon presentation of an analysis plan and local approvement by ERB.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: From publication of study onwards. No time limit.
Access criteria: Contact with central contact person or principal investigator.
Start is estimated for Sep 2026; primary completion for Dec 2028, 27 months later.
Of 74 non-industry phase 4 interventional studies under Ischemic Stroke, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 41. This study's planned 27 months is below that.
Counting every sponsor, half of 83 studies reached it within 31 months; a quarter within 24 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Hospital San Carlos, Madrid