← Back to Search

Procedure

SwishKit + Oral care treatment as usual for Oral Bacterial Infection (EASIER Trial)

N/A

Waitlist Available

Led By Marcelo Gama de Abreu, MD

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults, 18 years or older

Intubated with an oral endotracheal tube and expected to remain intubated for at least 2 days.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 2 days after enrolment

Awards & highlights

EASIER Trial Summary

This trial is going to compare the effectiveness of two different oral care treatments in patients who have a tube in their throat. The goal of the trial is to see which treatment can reduce the amount of bacteria

Who is the study for?

This trial is for patients who are intubated in intensive care and may have complications from mechanical ventilation or oral bacterial infections. Participants must be able to give consent themselves or through a legal representative.Check my eligibility

What is being tested?

The study is testing the effectiveness of a new device called Swiftsure SwishKit, used alongside standard oral care, in reducing bacteria in the mouth of intubated ICU patients compared to just standard oral care.See study design

What are the potential side effects?

Since this trial involves an oral hygiene device plus usual care, side effects might include discomfort in the mouth or an allergic reaction to materials in the SwishKit.

EASIER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I am on a breathing machine with a tube in my mouth and will be for at least 2 more days.

EASIER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 2 days after enrolment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 2 days after enrolment

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 2 days after enrolment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Bacterial load in the oropharyngeal space

Secondary outcome measures

16S rRNA sequencing of bacteria

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

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

Other outcome measures

Clinician Perception of Treatment Use/Efficacy

Feasibility aims

EASIER Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SwishKit + Oral care treatment as usualExperimental Treatment1 Intervention

SwishKit + Oral care Treatment as usual (TAU)

Group II: Oral care treatment as usualActive Control1 Intervention

Oral care Treatment as usual (TAU)

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

SwiftsureUNKNOWN

The Cleveland ClinicLead Sponsor

1,026 Previous Clinical Trials

1,366,055 Total Patients Enrolled

Marcelo Gama de Abreu, MDPrincipal InvestigatorThe Cleveland Clinic

2 Previous Clinical Trials

922 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers currently recruiting participants for this ongoing clinical trial?

"As per the information available on clinicaltrials.gov, this specific clinical trial is not currently open for participant enrollment. The initial posting date was January 15th, 2024, and the most recent update occurred on December 20th, 2023. However, it's worth noting that there are currently 82 other ongoing clinical trials actively seeking eligible participants at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Marcelo Gama de Abreu 2024. "Efficacy of A Novel RinSe Device to Reduce Oral Bacteria in Intubated IntEnsive CaRe Patients: a Pilot Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06193512.