Status:
RECRUITING
Efficacy of A Novel RinSe Device to Reduce Oral Bacteria in Intubated IntEnsive CaRe Patients: a Pilot Study
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
Swiftsure
Conditions:
Oral Bacterial Infection
Mechanical Ventilation Complication
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 oropharyn...
Detailed Description
Qualifying patients will be assigned on a 1:2 (control : treatment intervention) basis using computer-generated codes and random block sizes without stratification to the following groups: * Oral car...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT06193512
Start Date
March 8 2024
End Date
December 31 2025
Last Update
August 11 2025
Active Locations (1)
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1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195