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Could a 'robotic cough' stop deadly pneumonia in ICU patients?

NCT ID NCT06113939

Prevention Sponsor: Hospital San Carlos, Madrid Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 29, 2026 · Last updated Aug 07, 2026 · Updated 3 times

Summary

This pilot study tests two non-invasive methods to keep the airways clear in adults who are unconscious or severely ill and need a breathing tube. One method uses a special tube with continuous low-pressure suction, and the other delivers a programmed 'artificial cough' through the ventilator. The goal is to see if these approaches can prevent early pneumonia better than the current standard of care, which involves antibiotics or manual suctioning. The study includes 60 patients with conditions like severe trauma, stroke, or cardiac arrest, and follows them for 90 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
airway clearance device
What this could lead to
If successful, this could point toward safer, non-invasive ways to prevent lung infections in intensive care patients, reducing antibiotic use and complications.
What could go wrong
This is a small pilot study (60 patients), so results may not be definitive. The non-invasive devices might not work as well as current methods, and any approach could still fail to prevent infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria 1. Endotracheal intubation with an anticipated duration \> 48 hours. 2. High risk of early respiratory infection associated with a diagnosis of: 1. Severe trauma. 2. Severe traumatic brain injury. 3. Ischaemic or haemorrhagic stroke. 4. Other causes of impaired consciousness: post-resuscitated cardiac arrest status, intoxications, acute infections or diseases of the central nervous system, seizures. 3. 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). Exclusion criteria 1. Intubation with an anticipated duration \< 48 hours. 2. Foreseeable ominous prognosis within \< 7 days. 3. Already established indication for systemic antibiotic therapy, either for suspected aspiration pneumonia with radiological pulmonary infiltrate or for suspected non-respiratory source infection. 4. Active haemoptysis or pulmonary haemorrhage. 5. Unstable chest. 6. Undrained pneumothorax (inclusion may be considered once drained). 7. Known allergy or intolerance to beta-lactam antibiotics.

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Conditions

The condition(s) this trial relates to.

cardiac arrest Craniocerebral Trauma head injury hemorrhagic stroke injury intracerebral hemorrhage ischemic stroke Pneumonia, Ventilator-Associated post-cardiac arrest syndrome traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Airway clearance impairment Cardiac arrest Head trauma Intubation complication Stroke hemorrhagic Stroke, ischemic Ventilator associated pneumonia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Clinico San Carlos

    Madrid, Madrid, 28040, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.