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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment SwishKit for preventing complications in mechanically ventilated patients?

Research shows that comprehensive oral care, including regular toothbrushing and the use of antimicrobials, can significantly reduce the risk of ventilator-associated pneumonia (VAP) in patients on mechanical ventilation. In one study, implementing an oral care routine every 8 hours led to a zero rate of VAP in the intervention group. ^{1 2 3 4 5}

Is SwishKit (oral care treatment) safe for humans?

Chlorhexidine, a component often used in oral care for ventilated patients, has been linked to potential safety concerns, including excess mortality in some cases, although it is generally used to prevent infections like ventilator-associated pneumonia. ^{2 6 7 8 9}

How does the SwishKit oral care treatment differ from other treatments for preventing mechanical ventilation complications?

The SwishKit oral care treatment is unique because it focuses on comprehensive oral hygiene, including intensified mouth care with chlorhexidine and tooth brushing, to prevent ventilator-associated pneumonia (VAP) by reducing bacterial colonization in the mouth and trachea. This approach is more aggressive and frequent compared to standard oral care protocols, aiming to significantly lower the risk of infections in mechanically ventilated patients. ^{3 4 10 11 12}

Research Team

Marcelo Gama de Abreu, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

The effect of different oral hygiene treatments on the occurrence of ventilator associated pneumonia (VAP) in ventilated patients. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Oral care intervention to reduce incidence of ventilator-associated pneumonia in the neurologic intensive care unit. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

[VAP and oral hygiene.A systematic review]. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Improving oral care in patients receiving mechanical ventilation. [2015]

5. Spain pubmed.ncbi.nlm.nih.gov

[Effectiveness of oral care in the prevention of ventilator-associated pneumonia. systematic review and meta-analysis of randomised clinical trials]. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Ventilator-associated pneumonia, liver disease and oral chlorhexldine. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Meta-Analysis of the Efficacy and Safety of Chlorhexidine for Ventilator-Associated Pneumonia Prevention in Mechanically Ventilated Patients. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Prevention of ventilator-associated pneumonia with oral antiseptics: a systematic review and meta-analysis. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Protocol for a multi-centered, stepped wedge, cluster randomized controlled trial of the de-adoption of oral chlorhexidine prophylaxis and implementation of an oral care bundle for mechanically ventilated critically ill patients: the CHORAL study. [2020]

10. France pubmed.ncbi.nlm.nih.gov

[Evaluation of the effectiveness of a protocol of intensification of mouth care (teeth brushing and chlorhexidine 0.12%) on the colonisation of tracheal aspirations in intubated and ventilated patients in intensive care]. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Oropharyngeal Decontamination with Antiseptics to Prevent Ventilator-Associated Pneumonia: Rethinking the Benefits of Chlorhexidine. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Impact of oral hygiene on prevention of ventilator-associated pneumonia in neuroscience patients. [2019]