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

NCT06193512 | Active Not Recruiting FDA Device

• 1 other identifier: 23-884
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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 oropharyngeal space in orotracheally intubated patients. The trial will be conducted with IRB approval and written consent from patient or its legal representative.

Conditions

Mechanical Ventilation Complication; Oral Bacterial Infection

Outcome Measures

Primary Outcomes (1)

• Bacterial load in the oropharyngeal space

  Incidence of the presence of bacterial load in the oropharyngeal space from culture and qPCR of the five target pathogens: Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter spp.

  Within 5 days after enrolment.

Secondary Outcomes (3)

• Colony-Forming Units/milliliter (ml) (CFU/ml)

  Within 5 days after enrolment.

• 16S rRNA sequencing of bacteria

  Within 5 days after enrolment.

• Colony-Forming Units/milliliter (ml) (CFU/ml) and 16S rRNA

  Within 2 days after enrolment

Other Outcomes (2)

• Clinician Perception of Treatment Use/Efficacy

  Within 5 days after enrolment.

• Feasibility aims

  Within 5 days after enrolment.

Study Arms (2)

SwishKit + Oral care treatment as usual

EXPERIMENTAL

SwishKit + Oral care Treatment as usual (TAU)

Device: SwishKit + Oral care treatment as usual

Oral care treatment as usual

ACTIVE COMPARATOR

Oral care Treatment as usual (TAU)

Procedure: Oral care treatment as usual

Interventions

SwishKit + Oral care treatment as usual DEVICE

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.

SwishKit + Oral care treatment as usual

Oral care treatment as usual PROCEDURE

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).

Oral care treatment as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Swiftsure: collaborator

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Study Officials

• Marcelo Gama de Abreu, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patients and Investigator will be specifically blinded to oral care management whereas the care provider will be unblinded to the oral care management.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: randomized controlled study

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: January 5, 2024
• Study Start: March 8, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)