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

Launched by THE CLEVELAND CLINIC · Dec 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the Swiftsure SwishKit, which aims to reduce harmful bacteria in the mouths of patients who are on a ventilator (a machine that helps them breathe) in the intensive care unit. The study will compare the usual oral care these patients receive with the additional use of this new device to see which one is more effective in keeping their mouths healthier and reducing infections.

To participate, individuals need to be at least 18 years old and must be intubated (have a tube placed in their throat to help them breathe) for at least two days. However, people with certain conditions, like facial injuries or infections, or those who have been intubated for over 24 hours in the past week, will not be eligible. Participants will need to give their consent or have a legal representative provide consent on their behalf. This trial is an important step in finding better ways to care for patients who are critically ill and on mechanical ventilation.

Gender

ALL

Eligibility criteria

• Inclusion 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.
• Exclusion Criteria:
• • 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.