NCT05578599

A Pilot Study Swiftsure

A Prospective, Single-center Clinical Pilot Study Evaluating Feasibility of the Swiftsure Complete Care System (CCS) in Intubated Adults Undergoing Mechanical Ventilation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the feasibility of using the Swiftsure Complete Care System (CCS) device as an adjunct to standard oral care procedures among intubated adult patients undergoing mechanical ventilation in the intensive care unit (ICU). This is a small study intended to gather initial feasibility before conducting a larger study. The feasibility of using the Swiftsure CSS device will be studied among 20 patients at a single study site.

Detailed description

This is a prospective, single-center, single-arm, non-blinded trial to assess the feasibility of using the Swiftsure CSS device as an adjunct to the standard oral care among intubated adult patients undergoing mechanical ventilation in the ICU. The CSS intervention will be performed 1 times per subject. The nurse performing the intervention will be asked to complete the study questionnaires after each device use.

Conditions

• Ventilated Patients

Interventions

Type	Name	Description
DEVICE	Swiftsure CCS device	The Swiftsure CSS device will be used twice per patient in addition to standard oral health care procedures among intubated adult patients undergoing mechanical ventilation in the ICU.

Timeline

• Start date: 2022-10-12
• Primary completion: 2023-02-16
• Completion: 2023-03-10
• First posted: 2022-10-13
• Last updated: 2023-03-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study