RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-03-08
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06193512

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults, 18 years or older
  2. * Individual or legally authorized representative consent
  3. * Intubated with an oral endotracheal tube and expected to remain intubated for at least 2 days.
  1. * Maxillofacial trauma (current maxillofacial trauma precluding standard oral care techniques)
  2. * Conditions precluding lateral Trendelenburg positioning (e.g., increased intracranial pressure, spinal instability, hemodynamic instability)
  3. * Oropharyngeal injury or infection
  4. * Orofacial edema precluding access for oral care
  5. * Known or anticipated difficult intubation
  6. * Endotracheal cuff air leak that clinicians believe precludes mouth lavage
  7. * Already intubated for more than 24 continuous hours within a week before enrollment.

Contacts and Locations

Study Contact

Fabio Rodriguez, MD
CONTACT
2164449950
rodrigf3@ccf.org
Daniel Sessler, MD
CONTACT
216 444-4900
sessled@ccf.org

Principal Investigator

Marcelo Gama de Abreu, MD
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-08
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2024-03-08
Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Oral Bacterial Infection
  • Mechanical Ventilation Complication