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

NCT06193512 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2026-04-30

No results posted yet for this study

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.

Conditions

  • Oral Bacterial Infection
  • Mechanical Ventilation Complication

Interventions

DEVICE

SwishKit + 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.

PROCEDURE

Oral 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).

Sponsors & Collaborators

  • Swiftsure

    collaborator UNKNOWN

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Marcelo Gama de Abreu, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-08
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06193512 on ClinicalTrials.gov