RecruitingNot ApplicableNCT06193512

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

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

Sponsor

The Cleveland Clinic

Enrollment

21 participants

Start Date

Mar 8, 2024

Study Type

INTERVENTIONAL

Conditions

Mechanical Ventilation Complication Oral Bacterial Infection

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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 Criteria7

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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Interventions

DEVICESwishKit + Oral care treatment as usual

SwishKit + Oral care Treatment as usual (TAU) group, instillation of chemical antimicrobial agents care and tooth brushing will be performed as in Oral Care TAU, but SwishKit care will be conducted after other oral care interventions, and prior to instillation of the chemical antimicrobial agent.

PROCEDUREOral care treatment as usual

Oral care will be delivered per standard operating procedure of the ICU, which may include the instillation of chemical agents for the purpose of reducing bacterial load, will be administered at 4-hour intervals, and tooth brushing performed twice daily (morning and evening).