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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Oral Bacterial Infection
Intervention / Treatment

-

Contacts and Locations

Cleveland

Cleveland Clinic Foundation, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The Cleveland Clinic,

Marcelo Gama de Abreu, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

2024-12-31