Efficacy of A Novel RinSe Device to Reduce Oral Bacteria in Intubated IntEnsive CaRe Patients: a … (NCT06193512) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Efficacy of A Novel RinSe Device to Reduce Oral Bacteria in Intubated IntEnsive CaRe Patients: a Pilot Study
United States21 participantsStarted 2024-03-08
Plain-language summary
We propose a randomized pilot/feasibility study comparing oral care treatment as usual (TAU) with Swiftsure SwishKit plus oral care TAU on the presence and magnitude of bacterial load in the oropharyngeal space in orotracheally intubated patients. The trial will be conducted with IRB approval and written consent from patient or its legal representative.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.