SwishKit for Mechanical Ventilation Complications

(EASIER Trial)

Overseen By Daniel Sessler, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Maxillofacial trauma, Oropharyngeal injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 5 days

21 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new oral care kit, called SwishKit, can reduce bacteria in the mouth and throat of people on a ventilator (a machine that assists with breathing). Participants will either receive standard oral care or use the SwishKit alongside standard care. The study seeks individuals who have been intubated (have a tube in their throat to assist with breathing) for less than 24 hours and are expected to need it for at least two more days. This could improve care for patients on ventilators by reducing potential complications from bacteria. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance oral care for ventilated patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that SwishKit is safe for orotracheally intubated patients?

Research has shown that chlorhexidine, commonly used in mouth care for ventilated patients, might pose some safety concerns. Some studies have linked it to higher death rates in certain situations, though not all patients experience these issues.

Prospective participants considering a clinical trial with SwishKit should discuss potential risks and benefits with the medical team. The team can provide specific information about how the treatment might affect individual cases. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SwishKit because it offers a fresh approach to preventing complications from mechanical ventilation. Unlike traditional oral care methods that rely solely on routine cleaning, SwishKit adds an innovative component to standard oral care. This new approach could potentially enhance the effectiveness of oral hygiene in ventilated patients, reducing risks like ventilator-associated pneumonia. By integrating SwishKit with usual oral care, researchers hope to discover a more robust method of keeping patients healthier while on mechanical ventilation.

What evidence suggests that this trial's treatments could be effective for reducing bacterial load in orotracheally intubated patients?

In this trial, participants will receive either the SwishKit alongside standard oral care treatment or standard oral care treatment alone. Research has shown that SwishKit might help reduce the risk of complications for patients using breathing machines. Studies have found that maintaining oral hygiene can lower the chances of developing ventilator-associated pneumonia (VAP), a common and serious issue. SwishKit aims to enhance oral care for these patients, potentially reducing germs in the mouth and throat. Other research has demonstrated that using oral care products can improve health by lowering bacterial counts. While specific data on SwishKit is still being gathered, its emphasis on oral health offers a promising approach to reducing infection risks. ^{1 3 4 6 7}

Who Is on the Research Team?

Marcelo Gama de Abreu, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Individual or legally authorized representative consent

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

Exclusion Criteria

Known or anticipated difficult intubation

Endotracheal cuff air leak that clinicians believe precludes mouth lavage

I cannot perform standard oral care due to facial injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either Oral care TAU or SwishKit + Oral care TAU for up to 5 days

5 days

Daily in-person visits for treatment administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Oral care treatment as usual
• SwishKit

Trial Overview 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.

How Is the Trial Designed?

Group I: SwishKit + Oral care treatment as usual Experimental Treatment 1 Intervention

SwishKit + Oral care Treatment as usual (TAU)

Group II: Oral care treatment as usual Active Control 1 Intervention

Oral care Treatment as usual (TAU)

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Swiftsure

Collaborator

Trials

1

Recruited

20+

Citations

1. withpower.com withpower.com/trial/phase-mechanical-ventilation-complication-2024-c5469

SwishKit for Mechanical Ventilation Complications What data supports the effectiveness of the treatment SwishKit for preventing complications in mechanically ventilated patients? Research shows that ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7095206/

Ventilator-associated pneumonia in adults: a narrative review VAP is associated with prolonged duration of mechanical ventilation and ICU stay. The estimated attributable mortality of VAP is around 10%, with higher ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06966817

The Effect of Two Different Oral Care Solutions on ... The aim of this observational study is to evaluate the effects of two different oral care solutions on ventilator-associated pneumonia and oral health in ...

4. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2023.1295277/full

Suction circuit flushing with chlorhexidine decreases ... The aim of the study is to assess the effectiveness of flushing multiple-used open endotracheal suction catheters and suctioning system with chlorhexidine ...

5. bmcinfectdis.biomedcentral.com bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-021-06383-2

The effect of ventilator-associated pneumonia on the ... The results delineated that the 90-day mortality of VAP patients in ICU was 33.33% and 180-day mortality was 37.62%. The 90-day and 180-day ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10063266/

Impact of oral care modalities on the incidence of ventilator ... According to global data, the incidence of VAP in ICU patients with mechanical ventilation is as high as 40% above. VAP is often accompanied by ...

7. ahrq.gov ahrq.gov/sites/default/files/wysiwyg/professionals/quality-patient-safety/hais/tools/mvp/mvp-report.pdf

Mechanically Ventilated Patients - Final Report Cohorts 1 and 2 had reductions in possible ventilator-associated pneumonia rates (44–55%). Rates for Cohort 3 remained stable. Based on the analysis of a ...