Efficacy of A Novel RinSe Device to Reduce Oral Bacteria in Intubated IntEnsive CaRe Patients: a Pilot Study

Running, not enrolling · Not applicable

Conditions studied: Oral Bacterial Infection, Mechanical Ventilation Complication

In brief

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.

Key facts

Study ID

NCT06193512

Run by

The Cleveland Clinic

People needed

21

Starts

2024-03-08

Expected to finish

2026-12-31

Last updated by the study team

2026-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Cleveland Clinic Foundation — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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