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New rinse gadget aims to cut infection risk for ICU patients

NCT ID NCT06193512

Disease control Sponsor: The Cleveland Clinic 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tests a new rinse device (SwishKit) plus standard oral care against standard care alone in 21 intubated ICU patients. The goal is to see if the device reduces harmful bacteria in the mouth and throat, which could lower the risk of lung infections. The study is small and early, so results will show if a larger trial is worthwhile.

What this could mean

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

Active substance
SwishKit device plus standard oral care
What this could lead to
If successful, this could lead to a simple way to lower infection risk in ICU patients on breathing tubes.
What could go wrong
This is a very small pilot study with only 21 participants, so results may not apply to all ICU patients. The device adds to standard care, so its specific benefit may be hard to measure.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 21 people

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

Started

Mar 2024

Expected to finish

Dec 2026

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: * Adults, 18 years or older * Individual or legally authorized representative consent * Intubated with an oral endotracheal tube and expected to remain intubated for at least 2 days. Exclusion Criteria: * Maxillofacial trauma (current maxillofacial trauma precluding standard oral care techniques) * Conditions precluding lateral Trendelenburg positioning (e.g., increased intracranial pressure, spinal instability, hemodynamic instability) * Oropharyngeal injury or infection * Orofacial edema precluding access for oral care * Known or anticipated difficult intubation * Endotracheal cuff air leak that clinicians believe precludes mouth lavage * Already intubated for more than 24 continuous hours within a week before enrollment.

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Conditions

The condition(s) this trial relates to.

bacterial infectious disease

As listed by the trial registrant

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

Mechanical ventilation complication Oral bacterial infection

Contacts and locations

Locations

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

More trials for these conditions

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