Using a new device to reduce oral bacteria in intubated ICU patients
Efficacy of A Novel RinSe Device to Reduce Oral Bacteria in Intubated IntEnsive CaRe Patients: a Pilot Study (EASIER PILOT)
This study is testing a new device called the Swiftsure SwishKit to see if it can lower the amount of bacteria in the mouths of patients who are on a breathing tube in the ICU.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 21 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06193512 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the effectiveness of the Swiftsure SwishKit in reducing oral bacterial load in orotracheally intubated patients compared to standard oral care practices. Participants will be randomly assigned to receive either standard oral care or the SwishKit in addition to standard care. The study will monitor bacterial presence in the oropharyngeal space over a treatment period of up to five days or until extubation. The research will be conducted with appropriate ethical approvals and informed consent from participants or their legal representatives.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are intubated and expected to remain intubated for at least two days.
Not a fit: Patients with maxillofacial trauma or conditions that prevent standard oral care techniques may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of oral bacterial infections in critically ill patients on mechanical ventilation.
How similar studies have performed: While similar approaches have been explored, this specific intervention using the Swiftsure SwishKit is novel and has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Marcelo Gama de Abreu, MD — The Cleveland Clinic
- Study coordinator: Stephanie Stoianoff, MBA
- Email: stoians@ccf.org
- Phone: 216-444-0231
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.